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

NCT01289197 | Completed DMC

• 1 other identifier: 5R01HD057893-02
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Sleep Disorders; Physical Activity; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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.

  Yearly

Study Arms (2)

No Feedback or services offered.

NO INTERVENTION

The Family Check-Up is not offered.

Intervention

OTHER

Family Check Up is offered.

Behavioral: Family Check Up

Interventions

Family Check Up BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Motor Activity; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior; Behavioral Symptoms

Study Officials

• Daniel Shaw, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 3, 2011
• Study Start: April 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: January 11, 2016

Record last verified: 2016-01

Locations

US (1)