Clinical trial NCT03926221: Parent-Adolescent Interpersonal Processes in the Science of Behavior Change
Official title: Parent-Adolescent Interpersonal Processes in the Science of Behavior Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Adolescent Behavior
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-04-24
Enrollment: 112
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

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).

Primary outcomes:
measure: Number of BCTs used by parent coded from the Hot Topics Task
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Parent perception of general conflict between parent and child measured via Conflict Behavior Questionnaire
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Decisional balance proportion
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Subjective sleep quality measured via Pittsburgh Sleep Quality Index global score
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Secondary outcomes:
measure: Type of BCTs used by parent coded from the Hot Topics Task
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Number of negative and positive communication behaviors coded from the Hot Topics Task
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's perception of general conflict between parent and child measured via Conflict Behavior Questionnaire.
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth self-reported motivation of participating in TranS-C/making sleep behavior changes via the Intrinsic Motivation Questionnaire
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Regularity in sleep midpoint across the week measured via daily sleep diary
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Regularity in sleep midpoint across the week measured via actigraphy
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Morningness/eveningness preference measured via Children's Morningness Eveningness Preference Scale
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Other outcomes:
measure: Number of BCTs used by parent coded from the End of Treatment Conversation
timeFrame: Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Type of BCTs used by parent coded from the End of Treatment Conversation
timeFrame: Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Number of negative and positive communication behaviors coded from the End of Treatment Conversation
timeFrame: Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Number of conflicts and the mean anger intensity for parent
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Number of conflicts and the mean anger intensity for youth
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's subjective Bedtime measured via Daily Sleep Diary
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's subjective Wakeup Time measured via Daily Sleep Diary
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's subjective Sleep Onset Latency (SOL) measured via Daily Sleep Diary
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's subjective Wake After Sleep Onset (WASO) measured via Daily Sleep Diary
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's subjective Number of Awakenings measured via Daily Sleep Diary
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's subjective Time in Bed (TIB) measured via Daily Sleep Diary
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's subjective Naps measured via Daily Sleep Diary
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's subjective Total Sleep Time (TST) deviation score from developmental norms measured via Daily Sleep Diary
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's subjective Sleep Midpoint measured via Daily Sleep Diary
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's subjective Total Wake Time measured via Daily Sleep Diary
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's subjective Sleep Efficacy measured via Daily Sleep Diary
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's objective Bedtime measured via Actigraphy
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's objective Wakeup Time measured via Actigraphy
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's objective Sleep Onset Latency (SOL) measured via Actigraphy
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's objective Wake After Sleep Onset (WASO) measured via Actigraphy
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's objective Number of Awakenings measured via Actigraphy
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's objective Time in Bed (TIB) measured via Actigraphy
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's objective Naps measured via Actigraphy
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's objective Total Sleep Time (TST) deviation score from developmental norms measured via Actigraphy
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's objective Sleep Midpoint measured via Actigraphy
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's objective Total Wake Time measured via Actigraphy
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's objective Sleep Efficacy measured via Actigraphy
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Parent's perception of coercion in parent-child relationship measured via Parent-Child Coercion Scale
timeFrame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
measure: Youth's systolic blood pressure reactivity
timeFrame: 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.
measure: Youth's diastolic blood pressure reactivity
timeFrame: 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.
measure: Youth's heart rate variability
timeFrame: 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.
measure: Parent's systolic blood pressure reactivity
timeFrame: 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.
measure: Parent's diastolic blood pressure reactivity
timeFrame: 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.
measure: Parent's heart rate variability
timeFrame: 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.
Locations:
city: Berkeley
country: United States
facility: University of California, Berkeley
state: California
Study officials:
affiliation: University of California, Berkeley
name: Allison Harvey, PhD
role: PRINCIPAL_INVESTIGATOR
References: