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NCT01289197 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by University of Pittsburgh.

Completed
Registry status
NA
Development phase
324
Enrollment target

NCT01289197: Completed NA study, sponsored by University of Pittsburgh.

NCT01289197 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 324 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01289197, a NA study, has completed, sponsored by University of Pittsburgh.

COMPLETED
Registry status
NA
Development phase
324 participants
Enrollment target

Study Summary

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

Primary Outcome

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.

Interventions

  • BEHAVIORAL Family Check Up

Trial Details

FieldValue
Enrollment Target 324 participants
Start Date 2009-04
Est. Completion 2013-03
Phase NA
University of Pittsburgh

1,238 total trials

What the finished NCT01289197 record still lists

NCT01289197 is an interventional study that assigns participants to a tested intervention. The registered 324 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 1 intervention - of which Family Check Up is the first listed.

NCT01289197 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01289197 about?

NCT01289197 is a clinical study titled "Health Promotion in Early Adolescence: Sleep, Activity, and Emotion Regulation". 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 neuroma...

What is the current status of trial NCT01289197?

This trial is currently completed. It is a NA study. The enrollment target is 324 participants. The study started on 2009-04. Estimated completion is 2013-03.

What interventions are being tested in trial NCT01289197?

The interventions under investigation include: Family Check Up (BEHAVIORAL).

Who is sponsoring clinical trial NCT01289197?

This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01289197's enrollment target sits among peer trials

324 312th of 2000 higher than 1,686 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01289197, the US trial registry maintained by the National Library of Medicine. NCT01289197 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.