SMART Optimization of a Parenting Program for Active-duty Families
Condition: Parenting
Study type: Interventional

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).
    

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.
    

Intervention name(s): Phase 1: ADAPT Workshop; Phase 1: ADAPT Online; Phase 2: ADAPT Group; Phase 2: ADAPT Individual
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 2 day workshop; Online curriculum; 3 in person group sessions; 3 sessions in person one on one
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Sequential multiple assignment randomization trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Parenting; Military Families; Prevention