Parent-Adolescent Interpersonal Processes in the Science of Behavior Change
3 de noviembre de 2020 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
112
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
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California
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Berkeley, California, Estados Unidos, 94720-1650
- University of California, Berkeley
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
10 años a 18 años (Niño, Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of BCTs used by parent coded from the Hot Topics Task
Periodo de tiempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
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Parent measure.
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Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
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Parent perception of general conflict between parent and child measured via Conflict Behavior Questionnaire
Periodo de tiempo: 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.
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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
Periodo de tiempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
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Measured by Decision Balance Worksheet.
Youth measure.
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Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
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Subjective sleep quality measured via Pittsburgh Sleep Quality Index global score
Periodo de tiempo: 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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Type of BCTs used by parent coded from the Hot Topics Task
Periodo de tiempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
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Parent measure.
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Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
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Number of negative and positive communication behaviors coded from the Hot Topics Task
Periodo de tiempo: 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
|
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Youth's perception of general conflict between parent and child measured via Conflict Behavior Questionnaire.
Periodo de tiempo: 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
|
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Youth self-reported motivation of participating in TranS-C/making sleep behavior changes via the Intrinsic Motivation Questionnaire
Periodo de tiempo: 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.
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Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
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Regularity in sleep midpoint across the week measured via daily sleep diary
Periodo de tiempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
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Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
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Regularity in sleep midpoint across the week measured via actigraphy
Periodo de tiempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
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Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
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Morningness/eveningness preference measured via Children's Morningness Eveningness Preference Scale
Periodo de tiempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
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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.
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Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of BCTs used by parent coded from the End of Treatment Conversation
Periodo de tiempo: Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
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Parent measure.
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Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
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Type of BCTs used by parent coded from the End of Treatment Conversation
Periodo de tiempo: Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Parent measure.
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Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
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Number of negative and positive communication behaviors coded from the End of Treatment Conversation
Periodo de tiempo: Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Parent measure.
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Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
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Number of conflicts and the mean anger intensity for parent
Periodo de tiempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
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Measured via Issues Checklist.
Parent measure.
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Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
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Number of conflicts and the mean anger intensity for youth
Periodo de tiempo: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Measured via Issues Checklist.
Youth measure.
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Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
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Youth's subjective Bedtime measured via Daily Sleep Diary
Periodo de tiempo: 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.
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Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
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Youth's subjective Wakeup Time measured via Daily Sleep Diary
Periodo de tiempo: 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
|
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Youth's subjective Sleep Onset Latency (SOL) measured via Daily Sleep Diary
Periodo de tiempo: 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.
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Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
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Youth's subjective Wake After Sleep Onset (WASO) measured via Daily Sleep Diary
Periodo de tiempo: 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.
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Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
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Youth's subjective Number of Awakenings measured via Daily Sleep Diary
Periodo de tiempo: 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.
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Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
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Youth's subjective Time in Bed (TIB) measured via Daily Sleep Diary
Periodo de tiempo: 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
|
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Youth's subjective Naps measured via Daily Sleep Diary
Periodo de tiempo: 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
|
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Youth's subjective Total Sleep Time (TST) deviation score from developmental norms measured via Daily Sleep Diary
Periodo de tiempo: 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
|
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Youth's subjective Sleep Midpoint measured via Daily Sleep Diary
Periodo de tiempo: 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
|
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Youth's subjective Total Wake Time measured via Daily Sleep Diary
Periodo de tiempo: 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.
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Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
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Youth's subjective Sleep Efficacy measured via Daily Sleep Diary
Periodo de tiempo: 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.
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Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
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Youth's objective Bedtime measured via Actigraphy
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Parent's perception of coercion in parent-child relationship measured via Parent-Child Coercion Scale
Periodo de tiempo: 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.
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Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
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Youth's systolic blood pressure reactivity
Periodo de tiempo: 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.
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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.
|
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Youth's diastolic blood pressure reactivity
Periodo de tiempo: 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.
|
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Youth's heart rate variability
Periodo de tiempo: 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.
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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.
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Parent's systolic blood pressure reactivity
Periodo de tiempo: 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
Periodo de tiempo: 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.
|
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Parent's heart rate variability
Periodo de tiempo: 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.
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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.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de diciembre de 2018
Finalización primaria (Actual)
11 de agosto de 2020
Finalización del estudio (Actual)
26 de agosto de 2020
Fechas de registro del estudio
Enviado por primera vez
4 de abril de 2019
Primero enviado que cumplió con los criterios de control de calidad
22 de abril de 2019
Publicado por primera vez (Actual)
24 de abril de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de noviembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
3 de noviembre de 2020
Última verificación
1 de noviembre de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R21_parent_teen_study
- R21HD097819 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Parent Behavior Change Intervention (PBC-I) and Transdiagnostic Sleep and Circadian Intervention (TranS-C)
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VA Office of Research and DevelopmentRetiradoTrastornos del sueño y la vigilia | Alteración del sueño | Deterioro relacionado con el sueñoEstados Unidos