- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01289197
Health Promotion in Early Adolescence: Sleep, Activity, and Emotion Regulation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- To examine parent-child interaction as a mediator of change in child sleep, physical activity, and emotion regulation. Just as we are interested in the possibility that changes in child problem behavior and peer relationships are mediated by improvements in sleep, physical activity, and emotion regulation, we will examine aspects of improvements in sleep, physical activity, and emotion regulation that are mediated by improvements in the quality of parent-child interaction (e.g., parental involvement), based on both parent reports and observations of parent-child quality.
- To explore directional effects between sleep, daytime activity, daytime mood, emotion regulation, and affective and behavioral symptoms. For example, we will examine: a) if sleep difficulties will predict daytime measures of negative mood, irritability, and decreased physical activity the following day; or b) if daytime measures of stress and negative affect will predict sleep difficulties the subsequent night; c) if physical activity during the day will be associated with better sleep that night.
- To examine the impact of this intervention on measures of physical health (e.g., Body Mass Index and waist circumference) and academic function (e.g., days of school missed/tardiness and school performance).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No Feedback or services offered.
The Family Check-Up is not offered.
|
|
Other: Intervention
Family Check Up is offered.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Home visit assessment
Time Frame: Yearly
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Shaw, PhD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01HD057893-02 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
Clinical Trials on Family Check Up
-
Brown UniversityCompletedSubstance Use | Risky Sexual BehaviorUnited States
-
RTI InternationalUniversity of PittsburghCompletedSubstance UseUnited States
-
University of OregonRecruitingDepression | Parent-Child Relations | Parenting | Self-regulation | Problem Behavior in School | School AdjustmentUnited States
-
University of OregonCase Western Reserve UniversityCompletedDepression | Parent-Child Relations | Parenting | Self-regulationUnited States
-
McMaster UniversityUniversity of Calgary; Hamilton Health Sciences Corporation; Arizona State University and other collaboratorsCompletedBehavior Problems | Emotional ProblemsCanada
-
University of OregonNational Institute on Drug Abuse (NIDA)RecruitingDepression | Stress | Anxiety | Parent-Child Relations | Parenting | Substance Use Disorders | Pediatrics | Parenting Self-efficacyUnited States
-
University of OregonCompletedThe Positive Family Support Project - Partnering With Families for a Successful Transition to SchoolAchievementUnited States
-
Arizona State UniversityArizona Health Care Cost Containment SystemEnrolling by invitation
-
McMaster UniversityHamilton Health Sciences CorporationRecruitingAutism Spectrum Disorder | Behavior Problem | Emotional ProblemCanada
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)RecruitingDiabetes | Overweight | Hypertension, Pregnancy-Induced | Hypertension in Pregnancy | Obesity, MaternalUnited States