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Parent-Adolescent Interpersonal Processes in the Science of Behavior Change

3 novembre 2020 aggiornato da: University of California, Berkeley
This study seeks to examine a novel interpersonal target; namely, parent-teen conversations about youth health behavior change. The rationale is that parents have profound impacts on teen risk and vulnerability. Yet parents receive minimal training in the elements of conversations that optimally inspire their children toward engaging in healthy behaviors. A theoretically grounded and reliable taxonomy of behavior change techniques (BCTs) will be used as a basis for scientifically deriving the conversational elements, or micro-mechanisms, that reduce parent-teen conflict and facilitate upward spirals of healthful behavior change. This proposal builds on pilot data from a recently completed NICHD-funded R01 in which a sleep treatment improved sleep and reduced risk on selected outcomes in youth. While sleep-related health behaviors will be the focus of this R21, the research is designed to be relevant to a broad range of health behavior change. As part of an Administrative Supplement to the R21 awarded in Fall, 2019, two changes are made. First, measures of psychophysiology have been added to the Hot Topics Task. Second, an independent sample of teens who are healthy sleepers (n = 20), and their parents, will be tested on the protocol twice, 9 weeks apart. This comparison group is included to control for the passage of time and for completing the protocol twice. They do not receive an intervention.

Panoramica dello studio

Stato

Stato

Indica lo stato di reclutamento attuale o lo stato di accesso ampliato.
Completato

Condizioni

Condizioni

La malattia, il disturbo, la sindrome, la malattia o la lesione oggetto di studio. Su ClinicalTrials.gov, le condizioni possono includere anche altri problemi relativi alla salute, come la durata della vita, la qualità della vita e i rischi per la salute.

Intervento / Trattamento

Intervento / Trattamento

Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.

Tipo di studio

Tipo di studio

Descrive la natura di uno studio clinico. I tipi di studio includono studi interventistici (chiamati anche studi clinici), studi osservazionali (compresi i registri dei pazienti) e accesso allargato.
Interventistico

Iscrizione (Effettivo)

Iscrizione

Il numero di partecipanti a uno studio clinico. L'iscrizione "anticipata" è il numero target di partecipanti di cui i ricercatori hanno bisogno per lo studio.
112

Fase

Fase

La fase di una sperimentazione clinica che studia un farmaco o un prodotto biologico, sulla base delle definizioni sviluppate dalla Food and Drug Administration (FDA) statunitense. La fase si basa sull'obiettivo dello studio, sul numero di partecipanti e su altre caratteristiche. Ci sono cinque fasi: Early Phase 1 (precedentemente indicata come Fase 0), Phase 1, Phase 2, Phase 3 e Phase 4. Not Applicable è usato per descrivere sperimentazioni senza fasi definite dalla FDA, incluse sperimentazioni di dispositivi o interventi comportamentali.
  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • California
      • Berkeley, California, Stati Uniti, 94720-1650
        • University of California, Berkeley

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Criteri di ammissibilità

I requisiti chiave che devono soddisfare le persone che vogliono partecipare a uno studio clinico o le caratteristiche che devono avere. I criteri di ammissibilità sono costituiti sia da criteri di inclusione (necessari a una persona per partecipare allo studio) sia da criteri di esclusione (che impediscono a una persona di partecipare). I tipi di criteri di ammissibilità includono se uno studio accetta volontari sani, ha requisiti di età o gruppo di età o è limitato dal sesso.

Età idonea allo studio

Da 10 anni a 18 anni (Bambino, Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Age between 10 and 18 and living with a parent or guardian
  2. Lowest quartile of the widely used and well-validated Children's Morningness-Eveningness Preferences Scale (CMEP; 27 or lower) and
  3. Youth self-reported weekday sleep onset time for the past month later than 10:40 pm for 10- to 13-year- olds; 11:00pm for 14-16 year olds, and later than 11:20 for 17-18 year olds at least 3 nights per week;
  4. English language fluency;
  5. able and willing to give informed assent;
  6. at least one parent/primary caregiver who lives in the same household as the teen for at least 50% of the week must participate in all study sessions.

Exclusion Criteria:

  1. An active, progressive physical illness directly related to the onset and course of the sleep disturbance;
  2. evidence of sleep apnea, restless legs or periodic limb movements;
  3. significantly impairing pervasive developmental disorder;
  4. history of substance dependence in the past six months;
  5. suicide risk; bipolar disorder or schizophrenia or another current Axis I disorder if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed as a function of participating in any stage of this study;
  6. Participants will not be excluded if medications are stable (> 4 weeks).

Inclusion criteria (control group):

  1. Age between 10 and 18 and living with a parent or guardian
  2. (CMEP; 28 or higher) on Children's Morningness-Eveningness Preferences Scale
  3. Item #6 on the Pittsburgh Sleep Quality Index (PSQI) rated 'fairly' or 'very good'
  4. English language fluency;
  5. able and willing to give informed assent;
  6. at least one parent/primary caregiver who lives in the same household as the teen for at least 50% of the week must participate in all study sessions.

Exclusion Criteria (control group)

  1. An active, progressive physical illness directly related to the onset and course of the sleep disturbance;
  2. evidence of sleep apnea, restless legs or periodic limb movements;
  3. significantly impairing pervasive developmental disorder;
  4. history of substance dependence in the past six months;
  5. suicide risk; bipolar disorder or schizophrenia or another current Axis I disorder if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed as a function of participating in any stage of this study;
  6. Participants will not be excluded if medications are stable (> 4 weeks).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm

Gruppo di partecipanti / Arm

Un gruppo o sottogruppo di partecipanti a uno studio clinico che riceve un intervento/trattamento specifico o nessun intervento, secondo il protocollo dello studio.
Intervento / Trattamento

Intervento / Trattamento

Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
Sperimentale: PBC_I plus TranS-C
The Parent Behavior Change Intervention (PBC-I) is a behavioral intervention intended to teach parent behavior change techniques to better support their adolescents to improve sleep health behavior. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Comportamentale: Parent Behavior Change Intervention (PBC-I) and Transdiagnostic Sleep and Circadian Intervention (TranS-C)
PBC-I will be administered to the parent and TranS-C will be administered to the teenager. Both interventions are cognitive-behavioral and comprised of six weekly sessions. Parent and teenager sessions will be held in parallel.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misure di risultato primarie

Nel protocollo di uno studio clinico, la misura dell'esito pianificato più importante per valutare l'effetto di un intervento/trattamento. La maggior parte degli studi clinici ha una misura di esito primaria, ma alcuni ne hanno più di una.
Misura del risultato
Misura Descrizione
Lasso di tempo
Number of BCTs used by parent coded from the Hot Topics Task
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Parent measure.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Parent perception of general conflict between parent and child measured via Conflict Behavior Questionnaire
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Parent measure. 20 items each on a true/false scale. Total score ranges from 0 to 20 and is computed by adding up total score points. Higher scores indicate more general conflict.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Decisional balance proportion
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Measured by Decision Balance Worksheet. Youth measure.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Subjective sleep quality measured via Pittsburgh Sleep Quality Index global score
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. 19 items each on a 4-point scale. Global score ranges from 0 to 21 and is computed by totaling seven component scores. Lower scores indicate healthier sleep quality.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment

Misure di risultato secondarie

Misure di risultato secondarie

Nel protocollo di uno studio clinico, una misura dell'esito pianificato che non è importante quanto la misura dell'esito primario per valutare l'effetto di un intervento ma è comunque di interesse. La maggior parte degli studi clinici ha più di una misura di esito secondaria.
Misura del risultato
Misura Descrizione
Lasso di tempo
Type of BCTs used by parent coded from the Hot Topics Task
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Parent measure.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Number of negative and positive communication behaviors coded from the Hot Topics Task
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Parent measure.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's perception of general conflict between parent and child measured via Conflict Behavior Questionnaire.
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. 20 items each on a true/false scale. Total score ranges from 0 to 20 and is computed by adding up total score points. Higher scores indicate more general conflict.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth self-reported motivation of participating in TranS-C/making sleep behavior changes via the Intrinsic Motivation Questionnaire
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. 18 items on a 7-point Likert scale, with three subscales being used: Interest/Enjoyment, Perceived Competence, and Effort/Importance. Total score ranges from 3 to 21 (1-7 for each subscale score) and is computed by averaging items within each subscale and adding the 3 subscale scores.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Regularity in sleep midpoint across the week measured via daily sleep diary
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Regularity in sleep midpoint across the week measured via actigraphy
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Morningness/eveningness preference measured via Children's Morningness Eveningness Preference Scale
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. 10 items are weighed on either 4- or 5-point scales. Total score ranges from 10 to 43 and is computed by adding up total points. Scores between 10 and 20 indicate eveningness, scores between 28 and 42 indicate morningness, scores between 21 and 27 are categorized as neither.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment

Altre misure di risultato

Altre misure di risultato

Per gli studi clinici, una misurazione pianificata descritta nel protocollo utilizzata per determinare l'effetto di un intervento/trattamento sui partecipanti. Per gli studi osservazionali, una misurazione o un'osservazione utilizzata per descrivere modelli di malattie o tratti o associazioni con esposizioni, fattori di rischio o trattamento. I tipi di misure di esito includono la misura dell'esito primario e la misura dell'esito secondario.
Misura del risultato
Misura Descrizione
Lasso di tempo
Number of BCTs used by parent coded from the End of Treatment Conversation
Lasso di tempo: Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
Parent measure.
Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
Type of BCTs used by parent coded from the End of Treatment Conversation
Lasso di tempo: Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
Parent measure.
Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
Number of negative and positive communication behaviors coded from the End of Treatment Conversation
Lasso di tempo: Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
Parent measure.
Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
Number of conflicts and the mean anger intensity for parent
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Measured via Issues Checklist. Parent measure.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Number of conflicts and the mean anger intensity for youth
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Measured via Issues Checklist. Youth measure.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's subjective Bedtime measured via Daily Sleep Diary
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. Self-report of Bedtime in hour : minutes. Bedtime discrepancy between weeknights and weekend nights is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's subjective Wakeup Time measured via Daily Sleep Diary
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. Self-report of Wakeup Time in hour : minutes. Wakeup Time discrepancy between weeknights and weekend nights is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's subjective Sleep Onset Latency (SOL) measured via Daily Sleep Diary
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. Self-report of SOL in hour : minutes. SOL discrepancy between weeknights and weekend nights is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's subjective Wake After Sleep Onset (WASO) measured via Daily Sleep Diary
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. Self-report of WASO in hour : minutes. WASO discrepancy between weeknights and weekend nights is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's subjective Number of Awakenings measured via Daily Sleep Diary
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. Self-report of Number of Awakenings. Number of Awakenings discrepancy between weeknights and weekend nights is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's subjective Time in Bed (TIB) measured via Daily Sleep Diary
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. Self-report of TIB in hour : minutes. TIB discrepancy between weeknights and weekend nights is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's subjective Naps measured via Daily Sleep Diary
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. Self-report of Naps in hour : minutes. Naps discrepancy between weeknights and weekend nights is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's subjective Total Sleep Time (TST) deviation score from developmental norms measured via Daily Sleep Diary
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. TST in minutes is computed for weeknights and weekend nights by using self-report of daily Bedtime, Wakeup Time, Sleep Onset Latency (SOL), Wake After Sleep Onset (WASO), Naps. TST discrepancy between weeknights and weekend nights is calculated. TST deviation score from developmental norms is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post-assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's subjective Sleep Midpoint measured via Daily Sleep Diary
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. Sleep Midpoint in hour : minutes is computed for weeknights and weekend nights by subtracting Waketime from Bedtime and dividing the difference by TST [(bedtime-waketime)/TST]. Sleep Midpoint discrepancy between weeknights and weekend nights is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's subjective Total Wake Time measured via Daily Sleep Diary
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youths measure. Total Wake Time in minutes is computed for weeknights and weekend nights by adding up Sleep Onset Latency and Wake After Sleep Onset (WASO). Total Wake Time discrepancy between weeknights and weekend nights is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's subjective Sleep Efficacy measured via Daily Sleep Diary
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. Sleep Efficacy in minutes is computed for weeknights and weekend nights by dividing Total Sleep Time (TST) by Time in Bed (TIB) times 100 (TST/TIB x 100). Sleep Efficacy discrepancy between weeknights and weekend nights is calculated. Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's objective Bedtime measured via Actigraphy
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. Objective method of monitoring Bedtime in hour : minutes. Bedtime discrepancy between weeknights and weekend nights is calculated. Actigraphy is obtained over a period of 7 days at pre and post assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's objective Wakeup Time measured via Actigraphy
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. Objective method of monitoring Wakeup Time in hour : minutes. Wakeup Time discrepancy between weeknights and weekend nights is calculated. Actigraphy is obtained over a period of 7 days at pre and post assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's objective Sleep Onset Latency (SOL) measured via Actigraphy
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. Objective method of monitoring SOL in hour : minutes. SOL discrepancy between weeknights and weekend nights is calculated. Actigraphy is obtained over a period of 7 days at pre and post assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's objective Wake After Sleep Onset (WASO) measured via Actigraphy
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. Objective method of monitoring WASO in hour : minutes. WASO discrepancy between weeknights and weekend nights is calculated. Actigraphy is obtained over a period of 7 days at pre and post assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's objective Number of Awakenings measured via Actigraphy
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. Objective method of monitoring Number of Awakenings in hour : minutes. Number of Awakenings discrepancy between weeknights and weekend nights is calculated. Actigraphy is obtained over a period of 7 days at pre and post assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's objective Time in Bed (TIB) measured via Actigraphy
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. Objective method of monitoring TIB in hour : minutes. TIB discrepancy between weeknights and weekend nights is calculated. Actigraphy is obtained over a period of 7 days at pre and post assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's objective Naps measured via Actigraphy
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. Objective method of monitoring Naps in hour : minutes. Naps discrepancy between weeknights and weekend nights is calculated. Actigraphy is obtained over a period of 7 days at pre and post assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's objective Total Sleep Time (TST) deviation score from developmental norms measured via Actigraphy
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. TST in minutes is computed for weeknights and weekend nights by using Bedtime, Wakeup Time, Sleep Onset Latency (SOL), Wake After Sleep Onset (WASO), Naps. TST discrepancy between weeknights and weekend nights is calculated. TST deviation score from developmental norms is calculated. Actigraphy is obtained over a period of 7 days at pre and post-assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's objective Sleep Midpoint measured via Actigraphy
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. Sleep Midpoint in hour : minutes is computed for weeknights and weekend nights by subtracting Waketime from Bedtime and dividing the difference by TST [(bedtime-waketime)/TST]. Sleep Midpoint discrepancy between weeknights and weekend nights is calculated. Actigraphy is obtained over a period of 7 days at pre and post assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's objective Total Wake Time measured via Actigraphy
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. Total Wake Time in minutes is computed for weeknights and weekend nights by adding up Sleep Onset Latency and Wake After Sleep Onset (WASO). Total Wake Time discrepancy between weeknights and weekend nights is calculated. Actigraphy is obtained over a period of 7 days at pre and post assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's objective Sleep Efficacy measured via Actigraphy
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. Sleep Efficacy in minutes is computed for weeknights and weekend nights by dividing Total Sleep Time (TST) by Time in Bed (TIB) times 100 (TST/TIB x 100). Sleep Efficacy discrepancy between weeknights and weekend nights is calculated. Actigraphy is obtained over a period of 7 days at pre and post assessment.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Parent's perception of coercion in parent-child relationship measured via Parent-Child Coercion Scale
Lasso di tempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Parent measure. 9 items each on a 5-point scale. Total score is computed by adding up total points and dividing them by the number of items completed. Total score ranges from 1 to 5. Higher scores indicate more coercion.
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's systolic blood pressure reactivity
Lasso di tempo: Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
Youth measure. Blood pressure is measured using an ambulatory blood pressure monitor during the Hot Topic Task. Readings will be averaged during the resting and task periods. Reactivity will be calculated as the change score between the resting and task periods.
Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
Youth's diastolic blood pressure reactivity
Lasso di tempo: Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
Youth measure. Blood pressure is measured using an ambulatory blood pressure monitor during the Hot Topic Task. Readings will be averaged during the resting and task periods. Reactivity will be calculated as the change score between the resting and task periods.
Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
Youth's heart rate variability
Lasso di tempo: Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
Youth measure. Heart rate variability is measured using an ambulatory electrocardiogram during the Hot Topic Task. HRV will be calculated as the root mean square of successive differences (RMSSD), which is the square root of the mean squared differences between successive beat-to-beat RR intervals.
Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
Parent's systolic blood pressure reactivity
Lasso di tempo: Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
Parent measure. Blood pressure is measured using an ambulatory blood pressure monitor during the Hot Topic Task. Readings will be averaged during the resting and task periods. Reactivity will be calculated as the change score between the resting and task periods.
Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
Parent's diastolic blood pressure reactivity
Lasso di tempo: Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
Parent measure. Blood pressure is measured using an ambulatory blood pressure monitor during the Hot Topic Task. Readings will be averaged during the resting and task periods. Reactivity will be calculated as the change score between the resting and task periods.
Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
Parent's heart rate variability
Lasso di tempo: Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
Parent measure. Heart rate variability is measured using an ambulatory electrocardiogram during the Hot Topic Task. HRV will be calculated as the root mean square of successive differences (RMSSD), which is the square root of the mean squared differences between successive beat-to-beat RR intervals.
Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sponsor

L'organizzazione o la persona che avvia lo studio e che ha autorità e controllo sullo studio.
University of California, Berkeley

Collaboratori

Collaboratori

Un'organizzazione diversa dallo sponsor che fornisce supporto per uno studio clinico. Questo supporto può includere attività relative al finanziamento, alla progettazione, all'implementazione, all'analisi dei dati o al reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

Inizio studio

La data effettiva in cui il primo partecipante è stato arruolato in uno studio clinico. La data di inizio dello studio "prevista" è la data che i ricercatori pensano sarà la data di inizio dello studio.
1 dicembre 2018

Completamento primario (Effettivo)

Completamento primario

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento per raccogliere i dati finali per la misura dell'esito primario. Il fatto che lo studio clinico sia terminato secondo il protocollo o sia stato interrotto non influisce su questa data. Per gli studi clinici con più di una misura di esito primario con diverse date di completamento, questo termine si riferisce alla data in cui la raccolta dei dati è completata per tutte le misure di esito primario. La data di completamento principale "prevista" è la data che i ricercatori ritengono sarà la data di completamento principale per lo studio.
11 agosto 2020

Completamento dello studio (Effettivo)

Completamento dello studio

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento/trattamento per raccogliere i dati finali per le misure di esito primarie, le misure di esito secondarie e gli eventi avversi (ovvero l'ultima visita dell'ultimo partecipante). La data di completamento dello studio "prevista" è la data che i ricercatori ritengono sarà la data di completamento dello studio.
26 agosto 2020

Date di iscrizione allo studio

Primo inviato

Primo inviato

La data in cui lo sponsor o il ricercatore dello studio ha inviato per la prima volta un record di studio a ClinicalTrials.gov. In genere c'è un ritardo di alcuni giorni tra la prima data di invio e la disponibilità del record su ClinicalTrials.gov (la prima data di invio).
4 aprile 2019

Primo inviato che soddisfa i criteri di controllo qualità

Primo inviato che soddisfa i criteri di controllo qualità

La data in cui lo sponsor dello studio o il ricercatore invia per la prima volta un record di studio che è coerente con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). Lo sponsor o lo sperimentatore potrebbe dover rivedere e inviare un record di studio una o più volte prima che i criteri di revisione QC di NLM siano soddisfatti. È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
22 aprile 2019

Primo Inserito (Effettivo)

Primo Inserito

La data in cui il record dello studio è stato disponibile per la prima volta su ClinicalTrials.gov dopo la conclusione della revisione del controllo di qualità (QC) della National Library of Medicine (NLM). In genere c'è un ritardo di alcuni giorni tra la data in cui lo sponsor dello studio o lo sperimentatore ha presentato il record dello studio e la prima data pubblicata.
24 aprile 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento pubblicato

La data più recente in cui le modifiche al record di uno studio sono state rese disponibili su ClinicalTrials.gov. Potrebbe esserci un ritardo tra il momento in cui le modifiche sono state inviate a ClinicalTrials.gov dallo sponsor o dallo sperimentatore dello studio (data di invio dell'ultimo aggiornamento) e la data di pubblicazione dell'ultimo aggiornamento.
5 novembre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo aggiornamento inviato che soddisfa i criteri QC

La data più recente in cui lo sponsor dello studio o il ricercatore ha presentato modifiche a un record di studio che sono coerenti con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
3 novembre 2020

Ultimo verificato

Ultimo verificato

La data più recente in cui lo sponsor dello studio o il ricercatore ha confermato che le informazioni su uno studio clinico su ClinicalTrials.gov sono accurate e aggiornate. Se uno studio con stato di reclutamento di reclutamento; non ancora reclutamento; o attivo, non reclutamento non è stato confermato negli ultimi 2 anni, lo stato di reclutamento dello studio viene mostrato come sconosciuto.
1 novembre 2020

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Altri numeri di identificazione dello studio

Identificatori o numeri ID diversi dal numero NCT assegnati a uno studio clinico dallo sponsor, dai finanziatori o da altri dello studio. Questi numeri possono includere identificatori univoci di altri registri di sperimentazione e numeri di sovvenzioni del National Institutes of Health.
  • R21_parent_teen_study
  • R21HD097819 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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