Back to resultsParent-Adolescent Interpersonal Processes in the Science of Behavior Change
Primary Purpose
Sleep Deprivation, Adolescent Behavior
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent Behavior Change Intervention (PBC-I) and Transdiagnostic Sleep and Circadian Intervention (TranS-C)
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Deprivation
Eligibility Criteria
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).
Sites / Locations
- University of California, Berkeley
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PBC_I plus TranS-C
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of BCTs used by parent coded from the Hot Topics Task
Parent measure.
Parent perception of general conflict between parent and child measured via Conflict Behavior Questionnaire
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.
Decisional balance proportion
Measured by Decision Balance Worksheet. Youth measure.
Subjective sleep quality measured via Pittsburgh Sleep Quality Index global score
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.
Secondary Outcome Measures
Type of BCTs used by parent coded from the Hot Topics Task
Parent measure.
Number of negative and positive communication behaviors coded from the Hot Topics Task
Parent measure.
Youth's perception of general conflict between parent and child measured via Conflict Behavior Questionnaire.
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.
Youth self-reported motivation of participating in TranS-C/making sleep behavior changes via the Intrinsic Motivation Questionnaire
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.
Regularity in sleep midpoint across the week measured via daily sleep diary
Youth measure.
Regularity in sleep midpoint across the week measured via actigraphy
Youth measure.
Morningness/eveningness preference measured via Children's Morningness Eveningness Preference Scale
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.
Full Information
NCT ID
NCT03926221
First Posted
April 4, 2019
Last Updated
November 3, 2020
Sponsor
University of California, Berkeley
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT03926221
Brief Title
Parent-Adolescent Interpersonal Processes in the Science of Behavior Change
Official Title
Parent-Adolescent Interpersonal Processes in the Science of Behavior Change
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
August 11, 2020 (Actual)
Study Completion Date
August 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Berkeley
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation, Adolescent Behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PBC_I plus TranS-C
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Parent Behavior Change Intervention (PBC-I) and Transdiagnostic Sleep and Circadian Intervention (TranS-C)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of BCTs used by parent coded from the Hot Topics Task
Description
Parent measure.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Parent perception of general conflict between parent and child measured via Conflict Behavior Questionnaire
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Decisional balance proportion
Description
Measured by Decision Balance Worksheet. Youth measure.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Subjective sleep quality measured via Pittsburgh Sleep Quality Index global score
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Secondary Outcome Measure Information:
Title
Type of BCTs used by parent coded from the Hot Topics Task
Description
Parent measure.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Number of negative and positive communication behaviors coded from the Hot Topics Task
Description
Parent measure.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's perception of general conflict between parent and child measured via Conflict Behavior Questionnaire.
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth self-reported motivation of participating in TranS-C/making sleep behavior changes via the Intrinsic Motivation Questionnaire
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Regularity in sleep midpoint across the week measured via daily sleep diary
Description
Youth measure.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Regularity in sleep midpoint across the week measured via actigraphy
Description
Youth measure.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Morningness/eveningness preference measured via Children's Morningness Eveningness Preference Scale
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Other Pre-specified Outcome Measures:
Title
Number of BCTs used by parent coded from the End of Treatment Conversation
Description
Parent measure.
Time Frame
Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Type of BCTs used by parent coded from the End of Treatment Conversation
Description
Parent measure.
Time Frame
Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Number of negative and positive communication behaviors coded from the End of Treatment Conversation
Description
Parent measure.
Time Frame
Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Number of conflicts and the mean anger intensity for parent
Description
Measured via Issues Checklist. Parent measure.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Number of conflicts and the mean anger intensity for youth
Description
Measured via Issues Checklist. Youth measure.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's subjective Bedtime measured via Daily Sleep Diary
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's subjective Wakeup Time measured via Daily Sleep Diary
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's subjective Sleep Onset Latency (SOL) measured via Daily Sleep Diary
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's subjective Wake After Sleep Onset (WASO) measured via Daily Sleep Diary
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's subjective Number of Awakenings measured via Daily Sleep Diary
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's subjective Time in Bed (TIB) measured via Daily Sleep Diary
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's subjective Naps measured via Daily Sleep Diary
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's subjective Total Sleep Time (TST) deviation score from developmental norms measured via Daily Sleep Diary
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's subjective Sleep Midpoint measured via Daily Sleep Diary
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's subjective Total Wake Time measured via Daily Sleep Diary
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's subjective Sleep Efficacy measured via Daily Sleep Diary
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's objective Bedtime measured via Actigraphy
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's objective Wakeup Time measured via Actigraphy
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's objective Sleep Onset Latency (SOL) measured via Actigraphy
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's objective Wake After Sleep Onset (WASO) measured via Actigraphy
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's objective Number of Awakenings measured via Actigraphy
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's objective Time in Bed (TIB) measured via Actigraphy
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's objective Naps measured via Actigraphy
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's objective Total Sleep Time (TST) deviation score from developmental norms measured via Actigraphy
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's objective Sleep Midpoint measured via Actigraphy
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's objective Total Wake Time measured via Actigraphy
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's objective Sleep Efficacy measured via Actigraphy
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Parent's perception of coercion in parent-child relationship measured via Parent-Child Coercion Scale
Description
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.
Time Frame
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Title
Youth's systolic blood pressure reactivity
Description
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.
Time Frame
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.
Title
Youth's diastolic blood pressure reactivity
Description
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.
Time Frame
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.
Title
Youth's heart rate variability
Description
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.
Time Frame
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.
Title
Parent's systolic blood pressure reactivity
Description
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.
Time Frame
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.
Title
Parent's diastolic blood pressure reactivity
Description
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.
Time Frame
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.
Title
Parent's heart rate variability
Description
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.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison Harvey, PhD
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94720-1650
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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