Health Promotion in Early Adolescence: Sleep, Activity, and Emotion Regulation
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|ClinicalTrials.gov Identifier: NCT01289197|
Recruitment Status : Completed
First Posted : February 3, 2011
Last Update Posted : January 11, 2016
|Condition or disease||Intervention/treatment|
|Sleep Disorders Physical Activity Depression Anxiety||Behavioral: Family Check Up|
The primary objective of this project is to examine the short and long-term effects of an intervention focusing on three interrelated dimensions of health: improving sleep, increasing physical activity, and improving skills in emotion regulation. This intervention targets high-risk youth at a key neuromaturational period—early adolescence—when many individuals are experiencing new challenges to regulatory systems involved in sleep, activity, and emotion regulation.
To examine the effects of the intervention on sleep, physical activity, and emotion regulation:
Hypothesis 1a: The intervention will result in increased total sleep and more regularized sleep/wake schedules (as measured by Sensewear sleep/activity monitors and sleep logs in the home environment).
Hypothesis 1b: The intervention will result in increased physical activity and less time per week in sedentary activity (as measured by Sensewear activity monitors and standardized physical activity questionnaire).
Hypothesis 1c: The intervention will result in improved emotion regulation (as measured by a composite index derived from interaction tasks, as well as home and school measures of emotion regulation).
To examine intervention effects on externalizing (problem behavior), internalizing symptoms, and peer relationships.
Hypothesis 2a: The intervention will result in lower levels of externalizing and internalizing symptoms and improved relationships with peers as measured by parent, youth, and teacher reports.
Hypothesis 2b: Intervention effects for lower levels of externalizing and internalizing symptoms and improved relationships with peers, if found, will be mediated by improvements in child sleep, physical activity, and emotion regulation.
SECONDARY AIMS: In addition to these specific aims the following exploratory analyses are planned:
- To examine parent-child interaction as a mediator of change in child sleep, physical activity, and emotion regulation. Just as we are interested in the possibility that changes in child problem behavior and peer relationships are mediated by improvements in sleep, physical activity, and emotion regulation, we will examine aspects of improvements in sleep, physical activity, and emotion regulation that are mediated by improvements in the quality of parent-child interaction (e.g., parental involvement), based on both parent reports and observations of parent-child quality.
- To explore directional effects between sleep, daytime activity, daytime mood, emotion regulation, and affective and behavioral symptoms. For example, we will examine: a) if sleep difficulties will predict daytime measures of negative mood, irritability, and decreased physical activity the following day; or b) if daytime measures of stress and negative affect will predict sleep difficulties the subsequent night; c) if physical activity during the day will be associated with better sleep that night.
- To examine the impact of this intervention on measures of physical health (e.g., Body Mass Index and waist circumference) and academic function (e.g., days of school missed/tardiness and school performance).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||324 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Health Promotion in Early Adolescence: Sleep, Activity, and Emotion Regulation|
|Study Start Date :||April 2009|
|Primary Completion Date :||March 2013|
|Study Completion Date :||March 2013|
No Intervention: No Feedback or services offered.
The Family Check-Up is not offered.
Family Check Up is offered.
Behavioral: Family Check Up
Families in the intervention condition will be contacted by the parent consultant following the T1 and T2 assessments and be invited to participate in the Family Check-Up (FCU). The FCU intervention involves at least three sessions in which we expect both mother and child to participate in. First is the in-home family assessment. The second session involves rapport-building via an initial interview with the caregiver(s), referred to as the Get-to-Know-You visit, or for families already enrolled in an ongoing study, a Check-Back-In visit. The third is a Feedback Session during which the results of the assessment and initial interview are discussed with the caregiver, with attention focused on the caregiver's and child's readiness to change and the delineation of specific change options.
- Home visit assessment [ Time Frame: Yearly ]Includes caregiver packets (including CBCL, Sleep Habits Questionnaire, and Modifiable Activity Questionnaire for Adolescents), child assessment (including Sleep Habits Questionnaire, Modifiable Activity Questionnaire for Adolescents, Children's Affective Dysregulation Scale, and Children's Affective Lability Scale) and Parent-Child videotaped discussions. Additionally, child will be fitted with a SenseWear Armband device.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01289197
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Daniel Shaw, PhD||University of Pittsburgh|