Thrive Intervention in Schools

NCT06139874 | Enrolling By Invitation

• 1 other identifier: 202306092
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Mental Disorder

Keywords

Preschool; Parent-Child Relationship; Emotion Development; Therapy; Prevention

Outcome Measures

Primary Outcomes (1)

• Child Behavior Checklist

  Measure of child psychopathology/impairment (emotional and behavioral functioning). Raw scores are converted into T-scores. The T-scores range from 50 to 100, with higher scores indicating more problematic behaviors. T-scores above 65 indicate psychiatric symptoms.

  T1 (baseline), T2 (halfway through intervention), T3 (completion of intervention) and T4 (12 weeks post intervention)

Secondary Outcomes (4)

• The Emotion Regulation Checklist

  T1 (baseline), T3 (completion of intervention)

• Coping with Children's Negative Emotions Scale

  T1 (baseline), T2 (halfway through intervention), T3 (completion of intervention)

• Parenting Stress Index

  T1 (baseline), T3 (completion of intervention)

• Parent-Child Observed Interaction Coding

  T1 (baseline), T3 (completion of intervention)

Other Outcomes (1)

• Beck Depression Inventory-II

  T1 (baseline), T3 (completion of intervention)

Study Arms (3)

THRIVE Coached

EXPERIMENTAL

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

THRIVE Low Coached

EXPERIMENTAL

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

Parenting Wisely

ACTIVE COMPARATOR

Online asynchronous parenting training that parents will complete independently.

Behavioral: Parenting Wisely

Interventions

THRIVE BEHAVIORAL

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

THRIVE Coached; THRIVE Low Coached

Parenting Wisely BEHAVIORAL

Online asynchronous parenting program.

Parenting Wisely

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Near the clinical threshold on the Teacher or Parent Report Form
• An active primary caregiver can be identified and is available to participate in the intervention (mother, father, grandparent or any adult in this role)

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Early Emotional Development Program

St Louis, Missouri, 63108, United States

Location

Related Links

• Early Emotional Development Program Website

MeSH Terms

Conditions

Neurodevelopmental Disorders

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Joan Luby, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: August 9, 2024
• Primary Completion (Estimated): November 10, 2028
• Study Completion (Estimated): November 10, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)