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ParentingSMARTNCT05509348

SMART Optimization of a Parenting Program for Active-duty Families

A study testing Phase 1: ADAPT Workshop, Phase 1: ADAPT Online and Phase 2: ADAPT Group in people with Parenting, run by University of Minnesota at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Parenting
What is being tested?
Phase 1: ADAPT Workshop, Phase 1: ADAPT Online and Phase 2: ADAPT Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
423 participants
Where
4 sitesUnited States
Study dates
1 Jul 2017to 29 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • Fort Myer

    Arlington, Virginia, 22211

  • Fort Belvoir

    Fort Belvoir, Virginia, 22060

  • Fort Bragg

    Fort Bragg, North Carolina, 28303

  • Fort Campbell

    Fort Campbell North, Kentucky, 42223

Other trials in United States

About this study

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).

Read the detailed description

Deployment (and particularly high deployment operational tempo/OPTEMPO) can generate family and personal stressors that disrupt supportive social relationships and functioning at home, thereby weakening the strength of military force in the field. Stressors include separation from, and reunification with families, concerns about mobilizations and combat stressors. These stressors, in turn, are associated with reduced parenting effectiveness, marital/partner difficulties, emotion dysregulation, and increased coercion. Coercion predicts risk for child maladjustment, as well as marital disruptions. Without effective prevention interventions, such environments may contribute to high divorce rates, child maladjustment, and reductions in service member wellbeing.

Most prevention interventions use a one-size-fits-all approach (i.e. all participants receive the same dose, format, and type of program) but this approach is often inefficient. Some families benefit from this approach but many do not. Adaptive interventions maximize efficiency, scalability, and sustainability, by providing families with a tailored dose, timing, program format, and/or sequence to improve outcomes based on their preferences and needs.

After Deployment: Adaptive Parenting Tools (ADAPT) is a Parent Management Training-Oregon (PMTO) program for military families with children ages 5-12 years old. PMTO is a theoretically-based family of interventions with extensive research supporting efficacy and effectiveness. ADAPT was developed and tested primary with National Guard/Reserve families. Program findings, based on 3 RCTs, indicate positive outcomes. No empirically supported parent training programs have been validated in RCTs for active duty military families with school-aged children in regular and high deployment OPTEMPO contexts.

The investigators are proposing a Phase III Clinical trial. The SMART optimization of a parenting program for active-duty families uses an adaptive intervention strategy to optimize an evidence-based universal prevention intervention, After Deployment Adaptive Parenting Tools/(ADAPT). SMART trials are rapidly gaining recognition within the medical and mental health fields as an innovative approach to developing adaptive treatment regimens. SMARTs have been successfully implemented in diverse areas including interventions for cancer, autism spectrum disorders, adolescent depression, and alcoholism. SMARTs also show considerable promise in innovating intervention approaches within prevention contexts.

In this study, the investigators will compress and test a variety of formats, sequences, and doses of ADAPT. The investigators will provide two 'first line' ADAPT programs and two slightly more intensive booster ADAPT programs for families who do not 'respond' to the first line intervention. Adaptive intervention strategies involve decision rules that specify how the type or intensity of an intervention should change depending on participants' response on a predetermined indicator of initial progress within an intervention. Within a SMART, a measure of initial response is used following delivery of an intervention in order to evaluate each families' need for further intervention programming. In this way, programming is tailored to meet the needs of individual families by providing additional services only to those families who are likely to benefit. This measure of initial response is referred to as a primary tailoring variable. In the proposed study, the primary tailoring variable is parental locus of control, a key variable shown in prior studies to predict change in observed parenting effectiveness, as well as change in other outcomes (PTSD symptoms, suicidality, and child adjustment).

The tested formats, sequences, and doses of ADAPT include:

  1. Begin with ADAPT Online. Parents exhibiting initial response receive continued access to online resources. Parents exhibiting non-response are stepped-up to booster individual face-to-face ADAPT.
  2. Begin with ADAPT Online. Parents exhibiting initial response receive continued access to online resources. Parents exhibiting non-response are stepped -up to booster group-based ADAPT.
  3. Begin with ADAPT condensed group (with online support). Parents exhibiting initial response receive continued access to online resources. Parents exhibiting non-response are stepped to booster group-based ADAPT.
  4. Begin with ADAPT condensed group (with online support). Parents exhibiting initial response continue access to online resources. Parents exhibiting non-response are stepped-up to booster group-based ADAPT.

This approach allows families who do not need intensive services to receive appropriately brief services. Those higher-need families receive more intensive services.

To address Aim 1, the investigators will compress the ADAPT group and individual curriculum, through consultation with service members, spouse, and content experts. The investigators will conduct two focus groups with parents who have returned from deployment (including spouses) and live on military installations and will assemble a Panel of 7 experts via a video conference call to inform program modifications. Each of the two parent focus group will consist of 12 families (24 individuals), one group at Fort Bragg with Special Operations (SO) participants, one group at Joint Base Lewis-McChord (JBLM) and Ft. Campbell with 12 Regular Army (RA) participants. To ensure gender sensitivity, the investigators will recruit and ask similar questions of mothers and fathers.

The investigators will ask an Expert Panel to view and advise on modifications to the current ADAPT NG/R group and individual materials. After reviewing the report of the focus group results, an Expert Panel will gather via videoconference (Month 4). Panel experts will weigh in on the results and be provided with two weeks to provide written recommendations. Expert panel and focus group feedback will inform (i) how to best compress key ADAPT skills, and (ii) address issues specific to high deployment OPTEMPO conditions. The focus group data and panel feedback will be used to finalize components for the SMART.

To address Aims 2,3,4: Among 210 SO and 315 RA families (i.e., total N=525 families) with 5-12 year-old children, the investigators will examine effects of ADAPT modalities and sequences/timing on multiple behaviors and outcomes (i.e., (i) coercive family interactions, positive parenting, couple adjustment, and co-parenting, (ii) parents PTSD symptoms, depression symptoms, substance use, (iii) child behavior and emotional problems, and positive adjustment, by conducting a 2-stage SMART, and (iv) document participation, satisfaction, and fidelity. To assess behaviors and outcomes, the investigators will administer and collect a series of assessments at 4 timepoints.

For Aims 2, 3, and 4, the investigators will use a 2-stage SMART design to examine the optimal sequence, dosage, and delivery formats of ADAPT for active duty military families living in a range of operational tempo contexts. The investigators will recruit a total of 525 families living on three installations: FT Bragg, FTs Belvoir/Myer and FT Campbell, with 210 families recruited from FTs Bragg and Campbell, and 105 from FTs Belvoir/Myer.

Conditions
Parenting
Being tested
Phase 1: ADAPT Workshop, Phase 1: ADAPT Online, Phase 2: ADAPT Group, Phase 2: ADAPT Individual
Keywords
Parenting, Military Families, Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phase 1: ADAPT WorkshopBehavioural

    2 day workshop

  • Phase 1: ADAPT OnlineBehavioural

    Online curriculum

  • Phase 2: ADAPT GroupBehavioural

    3 in person group sessions

  • Phase 2: ADAPT IndividualBehavioural

    3 sessions in person one on one

Study groups in NCT05509348
Study groupRoleWhat they receive
Phase 1: ADAPT WorkshopExperimental2 - day long in-person workshops (7 hours each day). Workshops are 2 weeks apart.
Receives: Behavioral: Phase 1: ADAPT Workshop
Phase 1: ADAPT OnlineExperimental3 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.
Receives: Behavioral: Phase 1: ADAPT Online
Phase 2: ADAPT GroupExperimental3 - 2 hour long in-person group sessions. Group sessions are consecutive weeks.
Receives: Behavioral: Phase 2: ADAPT Group
Phase 2: ADAPT IndividualExperimental3 - 1 1/2 hour in-person individual sessions. Sessions are consecutive weeks.
Receives: Behavioral: Phase 2: ADAPT Individual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Observed Parenting Effectiveness

    Family Interaction Tasks (FIT) with each parent and child

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2022
  2. Study start1 Jul 2017
  3. Primary completion29 Sep 2022
  4. Study completion29 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Model description
Sequential multiple assignment randomization trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
423 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05509348
Sponsor's protocol ID
STUDY00015375
Other IDs
CDMRP-PT150093
Acronym
SMART
Status last verified
Nov 2022
First submitted
16 Jul 2019
Last updated
1 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22438190
  • 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.

    PubMed 24839882
  • 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.

    PubMed 17971530
  • 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.

    PubMed 17056207
  • 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.

    PubMed 25256135

Questions about this trial

What is this clinical trial studying?

A study testing Phase 1: ADAPT Workshop, Phase 1: ADAPT Online and Phase 2: ADAPT Group in people with Parenting, run by University of Minnesota at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Observed Parenting Effectiveness (time frame: T1 (baseline), T3 (1 year) and T4 (2 years). Change is being assessed, primarily change between T1 and T3.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05509348, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.

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