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
Completato
Condizioni
Tipo di studio
Interventistico
Iscrizione (Effettivo)
112
Fase
- 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
-
-
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
Età idonea allo studio
Da 10 anni a 18 anni (Bambino, Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Age between 10 and 18 and living with a parent or guardian
- Lowest quartile of the widely used and well-validated Children's Morningness-Eveningness Preferences Scale (CMEP; 27 or lower) and
- 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;
- English language fluency;
- able and willing to give informed assent;
- 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:
- An active, progressive physical illness directly related to the onset and course of the sleep disturbance;
- evidence of sleep apnea, restless legs or periodic limb movements;
- significantly impairing pervasive developmental disorder;
- history of substance dependence in the past six months;
- 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;
- Participants will not be excluded if medications are stable (> 4 weeks).
Inclusion criteria (control group):
- Age between 10 and 18 and living with a parent or guardian
- (CMEP; 28 or higher) on Children's Morningness-Eveningness Preferences Scale
- Item #6 on the Pittsburgh Sleep Quality Index (PSQI) rated 'fairly' or 'very good'
- English language fluency;
- able and willing to give informed assent;
- 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)
- An active, progressive physical illness directly related to the onset and course of the sleep disturbance;
- evidence of sleep apnea, restless legs or periodic limb movements;
- significantly impairing pervasive developmental disorder;
- history of substance dependence in the past six months;
- 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;
- 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 |
Intervento / Trattamento |
|---|---|
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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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
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.
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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
|
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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.
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Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Misure di risultato secondarie
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
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.
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)
1 dicembre 2018
Completamento primario (Effettivo)
11 agosto 2020
Completamento dello studio (Effettivo)
26 agosto 2020
Date di iscrizione allo studio
Primo inviato
4 aprile 2019
Primo inviato che soddisfa i criteri di controllo qualità
22 aprile 2019
Primo Inserito (Effettivo)
24 aprile 2019
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 novembre 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 novembre 2020
Ultimo verificato
1 novembre 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 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 .