- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02973906
Comparing Web, Group, and Telehealth Formats of a Military Parenting Program
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The overarching goal of this study is to advance research on family-based prevention of negative child outcomes for reintegrating Operation Enduring Freedom/Operation Iraqi Freedom personnel by evaluating different formats of a parenting program, After Deployment, Adaptive Parenting Tools (ADAPT). The ADAPT program is based upon the Parent Management Training-Oregon Model/PMTO, but adapted for military deployed families. The investigators will examine which of three delivery formats of ADAPT is most effective at reducing youth risk behaviors associated with negative childhood outcomes by improving parenting, child, and parent adjustment. There is a clear intent to benefit all subjects in this study (except surveyed teachers), including children.
Combat deployment and related challenges are family stressors, associated with more negative parent-child interactions, ineffective and coercive parenting practices and lower levels of parenting satisfaction. Disrupted parenting practices are well-known predictors of risk for child adjustment difficulties that are precursors to youth substance use, including behavior problems, school failure, deviant peer association, and depression . These child adjustment problems can contribute to continuing parental stress, increasing parental distress, and further disrupting parenting.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55415
- Institute for Translational Research in Children's Mental Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Inclusion criteria are:
- one parent has returned from deployment to OIF or OEF
- at least one child ages 5-12 in their custody and living with parent(s) in the home
- high speed internet access at home We will include both single-and two-parent families, as well as families where care is shared between non-partnered adults (e.g. grandparent and mother)
Exclusion Criteria:
- active psychosis
- an open child protection case for abuse or neglect in the family
- a serious child mental health diagnosis
- families who piloted material or participated in or are currently participating in the original ADAPT RCT.
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 |
|---|---|
|
Other: ADAPT Self Directed web
ADAPT Self Directed Web.
In the self-directed web-only ADAPT condition, participants have access to the full ADAPT website (10 modules, online discussion forum)
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In the self-directed web-only ADAPT condition, participants have access to the full ADAPT website (10 modules, online discussion forum
|
|
Other: ADAPT individualized web-facilitated
This condition comprises access to the full ADAPT web program with augmentation of individual facilitator web support (i.e. the facilitator connects via Google Hangout).
Facilitators meet with families at a mutually convenient time weekly (10-14 weeks, approximately 3 sessions per month).
|
This condition comprises access to the full ADAPT web program as described above, with augmentation of individual facilitator web support (i.e. the facilitator connects via Google Hangout).
Facilitators meet with families at a mutually convenient time weekly (10-14 weeks, approximately 3 sessions per month).
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Other: Group-based ADAPT
Groups will meet weekly for 120 minutes, at a time convenient to participants (usually early evening).
Groups cover core ADAPT/PMTO topics
|
Groups will meet weekly for 120 minutes, at a time convenient to participants (usually early evening).
Groups cover core ADAPT/PMTO topics:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in parenting practices and parent/child interactions
Time Frame: Change from Baseline, 6 months, 12 months, 24 months
|
Observed parenting is coded using FIT (Family Interaction Task) and self-report of parenting using the APQ (Alabama parenting Questionnaire),
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Change from Baseline, 6 months, 12 months, 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in child adjustment and substance use
Time Frame: Change from Baseline, 6 months, 12 months, 24 months
|
Child adjustment assessed using BASC-2 (teacher, parent, and child self-report); Child intentions and use of substances assess using the Alcohol Use Intentions and Behavior Scale; Child distress measured by CDI (Children's Depression Inventory); Child peer adjustment is measured by 16-item scale assessing loneliness and dissatisfaction with peer relations; Deviant peer association measured using "Describing Friends"
|
Change from Baseline, 6 months, 12 months, 24 months
|
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Change in parenting stress and support
Time Frame: Change from Baseline, 6 months, 12 months, 24 months
|
Parenting Stress Index-Short Form
|
Change from Baseline, 6 months, 12 months, 24 months
|
|
Participant report of satisfaction with intervention
Time Frame: Change from Baseline, 6 months, 12 months, 24 months
|
Two 10-item measures: (1) group satisfaction and (2) online satisfaction
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Change from Baseline, 6 months, 12 months, 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Abigail Gewirtz, PhD, Institute for Translational Research in Children's Mental Health University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1407S52001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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