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Clinical Trials/NCT03926221
NCT03926221
Completed
Not Applicable

Parent-Adolescent Interpersonal Processes in the Science of Behavior Change

University of California, Berkeley1 site in 1 country112 target enrollmentDecember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Deprivation
Sponsor
University of California, Berkeley
Enrollment
112
Locations
1
Primary Endpoint
Number of BCTs used by parent coded from the Hot Topics Task
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2018
End Date
August 26, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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'

Outcomes

Primary Outcomes

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.

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.

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.

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.

Secondary Outcomes

  • 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)
  • Morningness/eveningness preference measured via Children's Morningness Eveningness Preference Scale(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(Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment)
  • 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)
  • 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)

Study Sites (1)

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