Thrive Intervention in Schools
Part of paid clinical trials in St Louis, Missouri.
- Sponsor
- Washington University School of Medicine
- Study ID
- NCT06139874
- Status
- Enrolling By Invitation
Conditions
- Childhood Mental Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 3 Years - 7 Years
- Healthy Volunteers
- Not accepted
Interventions
- THRIVE — BEHAVIORALEarly intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention.
- Parenting Wisely — BEHAVIORALOnline asynchronous parenting program.
Study Details
This study is designed to test the effectiveness and implementation of an early intervention therapy for children and their primary caregivers by using existing school counselors across several school districts. The intervention is a 6-8 week caregiver-child intervention (THRIVE) which will be conducted via video conference in the family's home (i.e., zoom), or within the school setting (or a combination of those 2 modalities depending upon feasibility for the family). THRIVE will be compared to an asynchronous on-line parenting education program, Parenting Wisely (PW). This online parenting course will be accessed at www.parentingwisely.com. Existing school counselors will be trained in the delivery of THRIVE to 3-7 year old children (in preschool, kindergarten and first grade) and their primary caregivers. In addition to testing the effectiveness of THRIVE compared to PW, we will also compare two implementation strategies: THRIVE-Coached and THRIVE-Low Coached (LC). We will assess ongoing coaching of THRIVE trainees to increase therapist efficacy and adherence to the intervention (THRIVE-Coached). This will be compared to implementation of THRIVE with low supports (e.g. weekly supervision) provided only for the first case following the initial training (THRIVE-LC\]. Compared to those randomized to PW, we expect children who receive THRIVE will have significantly better behavioral and socio-emotional outcomes. Caregivers who receive THRIVE will experience less parenting stress and depression, more optimism and will show more nurturing, emotional tolerance, and supportive caregiving. Therapists in the THRIVE-Coached condition will deliver the intervention with higher achieved outcomes and find the intervention to be more acceptable than therapists in the THRIVE-LC condition. Therapists in the THRIVE-Coached condition will be more likely to plan to sustain the intervention following the completion of the study than those in the THRIVE-LC condition. Parents and children receiving THRIVE from therapists in the THRIVE-Coached condition will have better socio-emotional outcomes than those in the THRIVE-LC and PW conditions.
Key Dates
- Start date
- Aug 9, 2024
- Status verified
- Mar 2026
- Primary completion
- Nov 10, 2028
- Completion
- Nov 10, 2028
Study Design
- Enrollment
- 405 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: THRIVE CoachedThrive is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention. It will be delivered by school social workers/counselors. Following training in THRIVE, school therapists in this condition will receive ongoing weekly group supervision over the life of the study.
- Experimental: THRIVE Low CoachedThrive is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention. It will be delivered by school social workers/counselors. Following training in THRIVE, school therapists in this condition will receive weekly group supervision only during thier first THRIVE case.
- Active Comparator: Parenting WiselyOnline asynchronous parenting training that parents will complete independently.
Primary Outcome Measure
Child Behavior Checklist [ Time Frame: T1 (baseline), T2 (halfway through intervention), T3 (completion of intervention) and T4 (12 weeks post intervention) ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Early Emotional Development Program | St Louis | Missouri | 63108 | - |