Health Promotion in Early Adolescence: Sleep, Activity, and Emotion Regulation

Completed · Not applicable

Conditions studied: Sleep Disorders, Physical Activity, Depression, Anxiety

In brief

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.

Key facts

Study ID

NCT01289197

Run by

University of Pittsburgh

People needed

324

Starts

2009-04-01

Expected to finish

2013-03-01

Last updated by the study team

2016-01-11

Who can join

Age: 10 and older, up to 13. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eligibility in the study will be based on multiple criteria, including the family's low SES status (i.e., income less than 50% over the poverty line and no more than 2 years of college education for parents)
• Risk status on child problems with sleep, physical activity, and/or affect regulation. Criteria for the latter will be established using a 14-item screening procedure administered to parents.

You may not qualify if…

• Children or parents with severe mental health concerns that prohibit them from completing the assessment protocol or potentially benefiting from the intervention will not be eligible for participation (e.g., parents or children with severe mental retardation, autism, schizophrenia, or other psychotic disorders).
• If a child has a previous diagnosis of obstructive sleep apnea, they will still benefit from participating in the study and will not be excluded.
• Adolescents who are currently incarcerated or who are in a court mandated facility will be excluded from enrolling in the study.
• If an adolescent becomes incarcerated or is placed in a court mandated facility after enrollment in the study, he/she will be withdrawn from the study if the duration of incarceration or court mandated placement is longer than the amount of time remaining for study participation.
• However, adolescents who are transiently incarcerated (for example an adolescent who is detained for a week at juvenile detention facility) may resume research activities when he/she is no longer incarcerated or in a court mandated facility if the time remaining for study participation has not lapsed.
• No study procedures or activities will be conducted with any participant while he/she is incarcerated or in a court mandated facility.

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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