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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02973906
Other study ID # 1407S52001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2014
Est. completion date August 30, 2020

Study information

Verified date May 2021
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 PI 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 244
Est. completion date August 30, 2020
Est. primary completion date May 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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
ADAPT individualized web-facilitated
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).
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:

Locations

Country Name City State
United States Institute for Translational Research in Children's Mental Health Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in parenting practices and parent/child interactions Observed parenting is coded using FIT (Family Interaction Task) and self-report of parenting using the APQ (Alabama parenting Questionnaire), Change from Baseline, 6 months, 12 months, 24 months
Secondary Change in child adjustment and substance use 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
Secondary Change in parenting stress and support Parenting Stress Index-Short Form Change from Baseline, 6 months, 12 months, 24 months
Secondary Participant report of satisfaction with intervention Two 10-item measures: (1) group satisfaction and (2) online satisfaction Change from Baseline, 6 months, 12 months, 24 months
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