An interventional study of Family Check Up in Sleep Disorders, Physical Activity and Depression, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 10 Years to 13 Years. Per ClinicalTrials.gov, last updated 2016-01-11.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Prevention
The primary goal 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. This maturational period is also a crucial time in the normal development of habits, skills, and proclivities in each of these domains. Thus, early adolescence presents unique opportunities for intervention targeting these three interrelated regulatory systems. Participants will include 200 9-13 year-old children who are siblings of children enrolled in one of three ongoing studies of vulnerability and resilience, whose families were initially identified on the basis of sociodemographic, child, and/or family risk or are recruited thru local Family Centers. Children will be selected as having difficulties in at least one of these domains (sleep, sedentary behavior, or emotion regulation) and then randomly assigned to either a control or intervention group. All families will receive baseline, one- and two-year follow-up assessments of child sleep, physical activity, and emotion regulation. Families in the intervention group will have the opportunity to receive feedback and intervention services on these three child domains and other parenting and family issues (e.g., parent involvement, parent self-care, school problems) following the initial assessment and the one-year follow up. The intervention will involve the parent and target youth receiving feedback about the child's current status in these areas and family functioning. If desired, the family will also participate in follow-up meetings with the parent and/or target youth to improve the youth's sleep, physical activity, and/or emotion regulation skills, as well as aspects of the family environment. The investigators hypothesize that the intervention will be associated with improvements in sleep, physical activity, and emotion regulation among those in the intervention group, as well as improvements in measures of social, behavioral, and affective function. Finally, the investigators will explore the possibility that increases in parental involvement mediate some of the changes found in child sleep, physical activity, and emotion regulation.
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.
SPECIFIC AIMS:
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:
788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.
This study's enrollment of 324 is above the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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Exclusion Criteria:
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.
Also known as: Sleeping Tigers, Project MOVE
Home visit assessment
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.
Time frame: Yearly
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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University of Pittsburgh