Parent-Adolescent Interpersonal Processes in the Science of Behavior Change

NCT ID: NCT03926221

Last Updated: 2020-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2020-08-26

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

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

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).

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).

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of California, Berkeley

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allison Harvey, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Berkeley

Locations

University of California, Berkeley

Berkeley, California, United States

Countries

United States

Other Identifiers

R21HD097819

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R21_parent_teen_study

Identifier Type: -

Identifier Source: org_study_id