Thrive Intervention in Schools

Sponsor
Washington University School of Medicine (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06139874
Collaborator
(none)
405
1
3
60
6.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: THRIVE
  • Behavioral: Parenting Wisely
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
405 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Promoting Emotional Development Among Young Children Facing Adversity: An Effectiveness Implementation Study in St. Louis Schools
Anticipated Study Start Date :
Nov 10, 2023
Anticipated Primary Completion Date :
Nov 10, 2028
Anticipated Study Completion Date :
Nov 10, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: THRIVE Coached

Thrive 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.

Behavioral: THRIVE
Early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention.

Experimental: THRIVE Low Coached

Thrive 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.

Behavioral: THRIVE
Early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention.

Active Comparator: Parenting Wisely

Online asynchronous parenting training that parents will complete independently.

Behavioral: Parenting Wisely
Online asynchronous parenting program.

Outcome Measures

Primary Outcome Measures

  1. Child Behavior Checklist (CBCL) [T1 (baseline), T2 (halfway through intervention), T3 (completion of intervention) and T4 (12 weeks post intervention)]

    Measure of child psychopathology/impairment (emotional and behavioral functioning)

Secondary Outcome Measures

  1. The Emotion Regulation Checklist (ERC) [T1 (baseline), T3 (completion of intervention)]

    Measure of children's self-regulation that targets affective lability, intensity, valence, and flexibility

  2. Coping with Children's Negative Emotions Scale (CCNES) [T1 (baseline), T2 (halfway through intervention), T3 (completion of intervention)]

    measure of parental coping styles in response to children's negative emotions

  3. Parenting Stress Index [T1 (baseline), T3 (completion of intervention)]

    measure of potential dysfunctional parent-child relationships 96 and severity of parenting stress

  4. Parent-Child Observed Interaction Coding [T1 (baseline), T3 (completion of intervention)]

    objective ratings of the parent-child relationship functioning, parent emotion learning and child emotional competence

Other Outcome Measures

  1. Beck Depression Inventory-II (BDI-II) [T1 (baseline), T3 (completion of intervention)]

    measure of parental depression

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 7 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Near the clinical threshold on the Teacher or Parent Report Form

Exclusion Criteria:

Autism Major neurological disorder Participating in active weekly individual or family therapy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Early Emotional Development Program Saint Louis Missouri United States 63108

Sponsors and Collaborators

  • Washington University School of Medicine

Investigators

  • Principal Investigator: Joan Luby, PhD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Joan Luby, MD, Professor of Psychiatry, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT06139874
Other Study ID Numbers:
  • 202306092
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Joan Luby, MD, Professor of Psychiatry, Washington University School of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2023