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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03522610
Other study ID # 1005S82692
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 15, 2010
Est. completion date July 15, 2016

Study information

Verified date November 2023
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed project will produce and test the first combined group-online prevention program for reintegrating parents - "ADAPT: After Deployment Adaptive Parenting Tools". We will conduct a randomized effectiveness trial of the program, compared with a 'services as usual' (tip sheet) comparison group among 400 military families identified in the RFA as a special population: reintegrating Army National Guard parents.


Description:

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. Despite this, no parenting interventions have been empirically tested for reintegrating military families deployed to OEF/OIF. PMTO is a well-established empirically supported intervention targeting highly stressed parents that applies Social Interaction Learning theory. Similar to family stress and stress amplification models, SIL posits that parenting mediates the effects of family stressors on child adjustment. That is, deployment and related stressors would be expected to impair social interactional patterns, leading to increases in coercion, decrements in positive parenting, and increased risk for child maladjustment. PMTO interventions have demonstrated efficacy and effectiveness, showing benefits for children including reductions in behavior problems that are precursors to substance use, actual substance use, and internalizing problems, as well as increases in social competence and school adjustment. Moreover, recent findings indicate that strengthening parenting practices contributes to improved outcomes for parents themselves. While PMTO interventions have been implemented in multiple diverse contexts, no study to date has adapted and examined PMTO among military populations. Data from studies of the current wars demonstrate a strong need for accessible prevention interventions that reduce parent stress, enhance parenting, and promote family resilience. Specific aims of this study are as follows: 1. Examine the usability and feasibility of an adapted PMTO prevention program: After Deployment: Adaptive Parenting Tools/ADAPT 1. Conduct in-house testing and external usability evaluation of ADAPT online enhancement 2. Evaluate feasibility of ADAPT group component 2. Assess effectiveness of and satisfaction with ADAPT (group and web enhancement) program compared with a services-as-usual comparison group, among 400 reintegrating MN Army National Guard (MN ARNG) families with 6-12 year old children. 1. Assess effectiveness of ADAPT in (i) reducing coercion, and improving positive parenting practices, (ii) reducing child risk for substance use and related behavior problems, and (iii) improving parental adjustment, in the face of deployment and reintegration stressors. 2. Assess the capacity of ADAPT to yield higher parent satisfaction ratings than the services as-usual (tip sheet) comparison condition. 3. Within the ADAPT intervention group, detail and describe responsiveness to intervention. 1. Report dosage for group (face-to-face) and web components of ADAPT 2. Examine dosage as a potential moderator of intervention outcome 3. Examine fidelity of the implementation as a potential moderator of intervention outcome


Recruitment information / eligibility

Status Completed
Enrollment 360
Est. completion date July 15, 2016
Est. primary completion date July 15, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. one parent has returned from deployment to OIF or OEF, 2. at least one child in grades preK-6 in their custody and living with parent(s) in the home, and 3. high speed internet access at home (a recent MN study indicates that 97% deployed families have internet, with 70% using internet daily; Sayer et al., 2009). 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), and will control for relationship status in analyses. Participants must live within an hour's travel time of the Twin Cities Metro area, St Cloud, Mankato, Duluth, agree to randomization, and indicate willingness to interact with study materials and complete assessment batteries. Exclusion Criteria: 1. active psychosis, 2. an open child protection case for abuse or neglect in the family, 3. a serious child mental health diagnosis, 4. families who participated in the pilot ADAPT intervention (usability or feasibility) study described in Aim 1. MN NG data indicate that fewer than 10% families would be excluded based on a-c, above (personal correspondence, Polusny).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
ADAPT
Two hour, once a week in-person parenting program for 14 weeks plus use web-enhanced supplemental ADAPT materials

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Outcome

Type Measure Description Time frame Safety issue
Primary Assess effectiveness of the After Deployment: Adaptive Parenting Tools/ADAPT program Compare child adjustment with parental adjustment Change from Baseline, at 6 months , at 12 months , at 24 months
Secondary Examine dosage and participation in ADAPT. Report dosage for group (face-to-face) vs web components of ADAPT Change from Baseline, at 6 months, at 12 months, at 24 months
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