Parent-Adolescent Interpersonal Processes in the Science of Behavior Change

Adolescent Behavior Clinical Trial

Official title:

Parent-Adolescent Interpersonal Processes in the Science of Behavior Change

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03926221
• Other study ID #: R21_parent_teen_study
• Secondary ID: R21HD097819
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: August 26, 2020

Study information

• Verified date: November 2020
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: August 26, 2020
• Est. primary completion date: August 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Age between 10 and 18 and living with a parent or guardian

2. Lowest quartile of the widely used and well-validated Children's Morningness-Eveningness Preferences Scale (CMEP; 27 or lower) and

3. Youth self-reported weekday sleep onset time for the past month later than 10:40 pm for 10- to 13-year- olds; 11:00pm for 14-16 year olds, and later than 11:20 for 17-18 year olds at least 3 nights per week;

4. English language fluency;

5. able and willing to give informed assent;

6. at least one parent/primary caregiver who lives in the same household as the teen for at least 50% of the week must participate in all study sessions.

Exclusion Criteria:

1. An active, progressive physical illness directly related to the onset and course of the sleep disturbance;

2. evidence of sleep apnea, restless legs or periodic limb movements;

3. significantly impairing pervasive developmental disorder;

4. history of substance dependence in the past six months;

5. suicide risk; bipolar disorder or schizophrenia or another current Axis I disorder if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed as a function of participating in any stage of this study;

6. Participants will not be excluded if medications are stable (> 4 weeks).

Inclusion criteria (control group):

1. Age between 10 and 18 and living with a parent or guardian

2. (CMEP; 28 or higher) on Children's Morningness-Eveningness Preferences Scale

3. Item #6 on the Pittsburgh Sleep Quality Index (PSQI) rated 'fairly' or 'very good'

4. English language fluency;

5. able and willing to give informed assent;

6. at least one parent/primary caregiver who lives in the same household as the teen for at least 50% of the week must participate in all study sessions.

Exclusion Criteria (control group)

1. An active, progressive physical illness directly related to the onset and course of the sleep disturbance;

2. evidence of sleep apnea, restless legs or periodic limb movements;

3. significantly impairing pervasive developmental disorder;

4. history of substance dependence in the past six months;

5. suicide risk; bipolar disorder or schizophrenia or another current Axis I disorder if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed as a function of participating in any stage of this study;

6. Participants will not be excluded if medications are stable (> 4 weeks).

Related Conditions & MeSH terms

• Adolescent Behavior
• Sleep Deprivation

Intervention

Behavioral:
• Parent Behavior Change Intervention (PBC-I) and Transdiagnostic Sleep and Circadian Intervention (TranS-C)
PBC-I will be administered to the parent and TranS-C will be administered to the teenager. Both interventions are cognitive-behavioral and comprised of six weekly sessions. Parent and teenager sessions will be held in parallel.

Locations

Country	Name	City	State
United States	University of California, Berkeley	Berkeley	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Berkeley	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of BCTs used by parent coded from the End of Treatment Conversation	Parent measure.	Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
Other	Type of BCTs used by parent coded from the End of Treatment Conversation	Parent measure.	Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
Other	Number of negative and positive communication behaviors coded from the End of Treatment Conversation	Parent measure.	Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
Other	Number of conflicts and the mean anger intensity for parent	Measured via Issues Checklist. Parent measure.	Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Other	Number of conflicts and the mean anger intensity for youth	Measured via Issues Checklist. Youth measure.	Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Other	Youth's subjective Bedtime measured via Daily Sleep Diary	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
Other	Youth's subjective Wakeup Time measured via Daily Sleep Diary	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
Other	Youth's subjective Sleep Onset Latency (SOL) measured via Daily Sleep Diary	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
Other	Youth's subjective Wake After Sleep Onset (WASO) measured via Daily Sleep Diary	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
Other	Youth's subjective Number of Awakenings measured via Daily Sleep Diary	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
Other	Youth's subjective Time in Bed (TIB) measured via Daily Sleep Diary	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
Other	Youth's subjective Naps measured via Daily Sleep Diary	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
Other	Youth's subjective Total Sleep Time (TST) deviation score from developmental norms measured via Daily Sleep Diary	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
Other	Youth's subjective Sleep Midpoint measured via Daily Sleep Diary	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
Other	Youth's subjective Total Wake Time measured via Daily Sleep Diary	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
Other	Youth's subjective Sleep Efficacy measured via Daily Sleep Diary	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
Other	Youth's objective Bedtime measured via Actigraphy	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
Other	Youth's objective Wakeup Time measured via Actigraphy	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
Other	Youth's objective Sleep Onset Latency (SOL) measured via Actigraphy	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
Other	Youth's objective Wake After Sleep Onset (WASO) measured via Actigraphy	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
Other	Youth's objective Number of Awakenings measured via Actigraphy	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
Other	Youth's objective Time in Bed (TIB) measured via Actigraphy	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
Other	Youth's objective Naps measured via Actigraphy	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
Other	Youth's objective Total Sleep Time (TST) deviation score from developmental norms measured via Actigraphy	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
Other	Youth's objective Sleep Midpoint measured via Actigraphy	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
Other	Youth's objective Total Wake Time measured via Actigraphy	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
Other	Youth's objective Sleep Efficacy measured via Actigraphy	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
Other	Parent's perception of coercion in parent-child relationship measured via Parent-Child Coercion Scale	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
Other	Youth's systolic blood pressure reactivity	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.
Other	Youth's diastolic blood pressure reactivity	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.
Other	Youth's heart rate variability	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.
Other	Parent's systolic blood pressure reactivity	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.
Other	Parent's diastolic blood pressure reactivity	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.
Other	Parent's heart rate variability	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.
Primary	Number of BCTs used by parent coded from the Hot Topics Task	Parent measure.	Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Primary	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.	Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Primary	Decisional balance proportion	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
Primary	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.	Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Secondary	Type of BCTs used by parent coded from the Hot Topics Task	Parent measure.	Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Secondary	Number of negative and positive communication behaviors coded from the Hot Topics Task	Parent measure.	Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Secondary	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.	Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Secondary	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.	Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Secondary	Regularity in sleep midpoint across the week measured via daily sleep diary	Youth measure.	Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Secondary	Regularity in sleep midpoint across the week measured via actigraphy	Youth measure.	Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Secondary	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.	Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment