- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03926221
Parent-Adolescent Interpersonal Processes in the Science of Behavior Change
November 3, 2020 updated by: 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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
112
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Berkeley, California, United States, 94720-1650
- University of California, Berkeley
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of BCTs used by parent coded from the Hot Topics Task
Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Parent measure.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Parent perception of general conflict between parent and child measured via Conflict Behavior Questionnaire
Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Parent measure.
20 items each on a true/false scale.
Total score ranges from 0 to 20 and is computed by adding up total score points.
Higher scores indicate more general conflict.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Decisional balance proportion
Time Frame: 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
Time Frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
19 items each on a 4-point scale.
Global score ranges from 0 to 21 and is computed by totaling seven component scores.
Lower scores indicate healthier sleep quality.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Type of BCTs used by parent coded from the Hot Topics Task
Time Frame: 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
Time Frame: 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.
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of BCTs used by parent coded from the End of Treatment Conversation
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
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.
|
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
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.
|
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
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.
|
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
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.
|
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
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.
|
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
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2018
Primary Completion (Actual)
August 11, 2020
Study Completion (Actual)
August 26, 2020
Study Registration Dates
First Submitted
April 4, 2019
First Submitted That Met QC Criteria
April 22, 2019
First Posted (Actual)
April 24, 2019
Study Record Updates
Last Update Posted (Actual)
November 5, 2020
Last Update Submitted That Met QC Criteria
November 3, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21_parent_teen_study
- R21HD097819 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sleep Deprivation
-
University of PennsylvaniaCompletedSleep Restriction Then Total Sleep Deprivation | Total Sleep Deprivation Then Sleep RestrictionUnited States
-
Herlev HospitalTRYG Foundation; Danish Medical AssociationCompletedEffect of Sleep DeprivationDenmark
-
Christian BaumannCompletedAcute and Partial Sleep DeprivationSwitzerland
-
Dr. Osman HospitalCairo UniversityUnknownEffect of Insomnia and Sleep Deprivation in 3rdtrimesterEgypt
-
Hallym University Medical CenterCompletedWe Investigated the Effect of Sleep Deprivation on the Tear Film and Ocular Surface.Korea, Republic of
-
University of PittsburghNational Institute of Mental Health (NIMH)Not yet recruitingSleep | Sleep Disturbance | Insufficient SleepUnited States
-
Children's Hospital of PhiladelphiaEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedSleep | Sleep Disturbance | Sleep DeprivationUnited States
-
University of ChicagoCompleted
-
Beth Israel Deaconess Medical CenterNational Institute of Mental Health (NIMH)Active, not recruiting
Clinical Trials on Parent Behavior Change Intervention (PBC-I) and Transdiagnostic Sleep and Circadian Intervention (TranS-C)
-
University of California, BerkeleyEnrolling by invitationImplementing and Sustaining a Sleep Treatment to Improve Community Mental Health Part 3: SustainmentSleep Wake Disorders | Circadian Rhythm DisordersUnited States
-
University of California, BerkeleyRecruitingSleep Disorder | Memory ImpairmentUnited States
-
University of California, BerkeleyRecruitingSleep Disorder | Circadian DysregulationUnited States
-
University of California, BerkeleyRecruitingSleep Disorder | Circadian DysregulationUnited States
-
Chinese University of Hong KongNot yet recruitingDepression | Sleep Disorders, Circadian RhythmHong Kong
-
Chinese University of Hong KongUniversity of California, BerkeleyUnknownSleep Disturbance | Major Depressive DisorderHong Kong
-
Chinese University of Hong KongUniversity of California, BerkeleyCompleted
-
Children's Hospital Medical Center, CincinnatiCompleted
-
University of California, BerkeleyCompletedSleep Disorder | Feasibility | Sleep Disorders, Circadian Rhythm | Adaptation | Acceptability | Implementation ResearchUnited States
-
University of California, BerkeleyRecruitingSleep Disorder | Memory Impairment | Circadian DysregulationUnited States