NCT05509348

Brief Summary

The overarching goal of the "SMART Optimization of a Parenting Program for Active-Duty Families" study is to advance the "development, adaptation, efficiency or optimization, and testing of a prevention intervention by using a sequential, multiple assignment, randomized trial/SMART to test multiple components of an empirically-supported parent training prevention intervention - After Deployment Adaptive Parenting Tools (ADAPT) for active-duty families negotiating multiple deployments and high deployment OPTEMPO (an army program that provides critical responses).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
423

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

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 1, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2019

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2022

Completed
Last Updated

December 1, 2022

Status Verified

November 1, 2022

Enrollment Period

5.2 years

First QC Date

July 16, 2019

Last Update Submit

November 29, 2022

Conditions

Keywords

ParentingMilitary FamiliesPrevention

Outcome Measures

Primary Outcomes (1)

  • Change in Observed Parenting Effectiveness

    Family Interaction Tasks (FIT) with each parent and child

    T1 (baseline), T3 (1 year) and T4 (2 years). Change is being assessed, primarily change between T1 and T3.

Study Arms (4)

Phase 1: ADAPT Workshop

EXPERIMENTAL

2 - day long in-person workshops (7 hours each day). Workshops are 2 weeks apart.

Behavioral: Phase 1: ADAPT Workshop

Phase 1: ADAPT Online

EXPERIMENTAL

3 weeks are given to complete 12 online modules using a secure website. Online modules include skill video, practice video, summary sheets, mindfulness audio and exercise video, printable handouts and motivation questionnaire.

Behavioral: Phase 1: ADAPT Online

Phase 2: ADAPT Group

EXPERIMENTAL

3 - 2 hour long in-person group sessions. Group sessions are consecutive weeks.

Behavioral: Phase 2: ADAPT Group

Phase 2: ADAPT Individual

EXPERIMENTAL

3 - 1 1/2 hour in-person individual sessions. Sessions are consecutive weeks.

Behavioral: Phase 2: ADAPT Individual

Interventions

2 day workshop

Phase 1: ADAPT Workshop

Online curriculum

Phase 1: ADAPT Online

3 in person group sessions

Phase 2: ADAPT Group

3 sessions in person one on one

Phase 2: ADAPT Individual

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • families in which one parent has returned from deployment
  • families with at least one child age 5 to 12 in their custody and living with parent(s) in the home
  • must agree to randomization
  • must indicate willingness to interact with study materials and complete assessment batteries

You may not qualify if:

  • families with children younger than 5 or older than 12
  • families in which at least one parent has an active psychosis
  • families with an open child protection case for abuse or neglect in the family
  • families in which there is a child with a serious mental health diagnosis (i.e., autism, child psychosis)
  • youth who have a documented pervasive developmental disability or mental retardation
  • families who participated in the focus group
  • those with less than a 5th grade comprehension level in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Fort Campbell

Fort Campbell North, Kentucky, 42223, United States

Location

Fort Bragg

Fort Bragg, North Carolina, 28303, United States

Location

Fort Myer

Arlington, Virginia, 22211, United States

Location

Fort Belvoir

Fort Belvoir, Virginia, 22060, United States

Location

Related Publications (5)

  • Almirall D, Compton SN, Gunlicks-Stoessel M, Duan N, Murphy SA. Designing a pilot sequential multiple assignment randomized trial for developing an adaptive treatment strategy. Stat Med. 2012 Jul 30;31(17):1887-902. doi: 10.1002/sim.4512. Epub 2012 Mar 22.

    PMID: 22438190BACKGROUND
  • Kasari C, Kaiser A, Goods K, Nietfeld J, Mathy P, Landa R, Murphy S, Almirall D. Communication interventions for minimally verbal children with autism: a sequential multiple assignment randomized trial. J Am Acad Child Adolesc Psychiatry. 2014 Jun;53(6):635-46. doi: 10.1016/j.jaac.2014.01.019. Epub 2014 Mar 12.

    PMID: 24839882BACKGROUND
  • Thall PF, Logothetis C, Pagliaro LC, Wen S, Brown MA, Williams D, Millikan RE. Adaptive therapy for androgen-independent prostate cancer: a randomized selection trial of four regimens. J Natl Cancer Inst. 2007 Nov 7;99(21):1613-22. doi: 10.1093/jnci/djm189. Epub 2007 Oct 30.

    PMID: 17971530BACKGROUND
  • Murphy SA, Lynch KG, Oslin D, McKay JR, TenHave T. Developing adaptive treatment strategies in substance abuse research. Drug Alcohol Depend. 2007 May;88 Suppl 2(Suppl 2):S24-30. doi: 10.1016/j.drugalcdep.2006.09.008. Epub 2006 Oct 23.

    PMID: 17056207BACKGROUND
  • August GJ, Piehler TF, Bloomquist ML. Being "SMART" About Adolescent Conduct Problems Prevention: Executing a SMART Pilot Study in a Juvenile Diversion Agency. J Clin Child Adolesc Psychol. 2016 Jul-Aug;45(4):495-509. doi: 10.1080/15374416.2014.945212. Epub 2014 Sep 25.

    PMID: 25256135BACKGROUND

Related Links

Study Officials

  • Abigail Gewirtz, PhD

    University of Minnesota and Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Sequential multiple assignment randomization trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2019

First Posted

August 22, 2022

Study Start

July 1, 2017

Primary Completion

September 29, 2022

Study Completion

September 29, 2022

Last Updated

December 1, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations