Parent-Adolescent Interpersonal Processes in the Science of Behavior Change

NCT03926221 | Completed

• 2 other identifiers: R21_parent_teen_studyR21HD097819
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Deprivation; Adolescent Behavior

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (7)

• Type of BCTs used by parent coded from the Hot Topics Task

  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

  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.

  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

  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

  Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment

Other Outcomes (34)

• Number of BCTs used by parent coded from the End of Treatment Conversation

  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

  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

  Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment

Study Arms (1)

PBC_I plus TranS-C

EXPERIMENTAL

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.

Behavioral: Parent Behavior Change Intervention (PBC-I) and Transdiagnostic Sleep and Circadian Intervention (TranS-C)

Interventions

Parent Behavior Change Intervention (PBC-I) and Transdiagnostic Sleep and Circadian Intervention (TranS-C) BEHAVIORAL

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.

PBC_I plus TranS-C

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.
• 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;

Sponsors & Collaborators

• University of California, Berkeley: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of California, Berkeley

Berkeley, California, 94720-1650, United States

Location

MeSH Terms

Conditions

Sleep Deprivation; Adolescent Behavior

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Study Officials

• Allison Harvey, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 24, 2019
• Study Start: December 1, 2018
• Primary Completion: August 11, 2020
• Study Completion: August 26, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)