Sleep DisordersNCT01289197
Health Promotion in Early Adolescence: Sleep, Activity, and Emotion Regulation
A study testing Family Check Up in people with Sleep Disorders and Physical Activity, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 13 years
- Conditions the study is for
- Sleep Disorders, Physical Activity, Depression
- What is being tested?
- Family Check Up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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adolescent becomes incarcerated or is placed in a court mandated facility after enrollment in the study, he/she will be withdrawn from the study if the duration of incarceration or court mandated placement is longer than the amount of time remaining for study participation.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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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).
- Conditions
- Sleep Disorders, Physical Activity, Depression, Anxiety
- Being tested
- Family Check Up
- Medical subject headings
- Sleep Wake Disorders, Motor Activity, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Check UpBehavioural
Also called Sleeping Tigers, Project MOVE
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.
| Study group | Role | What they receive |
|---|---|---|
| No Feedback or services offered. | No intervention | The Family Check-Up is not offered. |
| Intervention | Other | Family Check Up is offered. Receives: Behavioral: Family Check Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startApr 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Shaw, University of Pittsburgh
- Investigators
- Daniel Shaw, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289197
- Sponsor's protocol ID
- 5R01HD057893-02
- Status last verified
- Jan 2016
- First submitted
- 1 Feb 2011
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Promotion in Early Adolescence: Sleep, Activity, and Emotion Regulation
- ClinicalTrials.gov ID
- NCT01289197
- Acronym / sponsor ID
- 5R01HD057893-02
- Conditions
- Sleep Disorders, Physical Activity, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 3 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Feedback or services offered. | No intervention | –The Family Check-Up is not offered. |
| Intervention | Other | Behavioral: Family Check UpFamily Check Up is offered. |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Check UpAlso: Sleeping Tigers, Project MOVEFamilies 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. | Behavioural | Intervention |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
Related trials for Sleep Disorders
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Shaw, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Check Up in people with Sleep Disorders and Physical Activity, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Home visit assessment (time frame: Yearly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2016.