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