NCT03522610

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

5 years

First QC Date

February 16, 2018

Last Update Submit

November 29, 2023

Conditions

Parenting

Keywords

PreventionMilitary FamiliesParenting

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Examine dosage and participation in ADAPT.

    Change from Baseline, at 6 months, at 12 months, at 24 months

Study Arms (2)

ADAPT

EXPERIMENTAL

Parents participate in a 14-week in person group based version of ADAPT with web-enhanced online ADAPT materials.

Behavioral: ADAPT

Comparison Group

NO INTERVENTION

Parents receive services as usual (pamphlets, brochures, etc) on parenting typically found at a VA or Dr.'s office.

Interventions

ADAPTBEHAVIORAL

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

ADAPT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • one parent has returned from deployment to OIF or OEF,
  • at least one child in grades preK-6 in their custody and living with parent(s) in the home, and
  • 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.

You may not qualify if:

  • active psychosis,
  • an open child protection case for abuse or neglect in the family,
  • a serious child mental health diagnosis,
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Gewirtz AH, DeGarmo DS, Lee S. What works better? 1-year outcomes of an effectiveness trial comparing online, telehealth, and group-based formats of a military parenting program. J Consult Clin Psychol. 2024 May;92(5):310-319. doi: 10.1037/ccp0000882. Epub 2024 Mar 28.

    PMID: 38546621DERIVED

  • DeGarmo DS, Gewirtz AH, Li L, Tavalire HF, Cicchetti D. The ADAPT Parenting Intervention Benefits Combat Exposed Fathers Genetically Susceptible to Problem Drinking. Prev Sci. 2023 Jan;24(1):150-160. doi: 10.1007/s11121-022-01424-x. Epub 2022 Sep 3.

    PMID: 36057024DERIVED

Related Links

Study Officials

  • Abigail Gewirtz, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study is a two-group randomized controlled effectiveness trial with baseline and three follow-up assessment points
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2018

First Posted

May 11, 2018

Study Start

July 15, 2010

Primary Completion

July 15, 2015

Study Completion

July 15, 2016

Last Updated

November 30, 2023

Record last verified: 2023-11