Health Promotion in Early Adolescence: Sleep, Activity, and Emotion Regulation
Public ClinicalTrials.gov record NCT01289197. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01289197
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 324 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 10 Years to 13 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2009
- Primary completion
- Feb 28, 2013
- Completion
- Feb 28, 2013
- Last update posted
- Jan 10, 2016
2009 – 2013
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01289197, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 10, 2016 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01289197 live on ClinicalTrials.gov.