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Enrolling by Invitation

NCT Number: NCT06139874

Thrive Intervention in Schools

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.

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Key information

Conditions

Childhood Mental Disorder Mental Disorders Neurodevelopmental Disorders

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Early Emotional Development Program

St Louis, Missouri, 63108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

Thrive

Behavioral

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

Parenting Wisely

Behavioral

Online asynchronous parenting program.

Primary outcomes

  1. Child Behavior Checklist

    Time frame: 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). 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.

Secondary outcomes

  1. The Emotion Regulation Checklist

    Time frame: T1 (baseline), T3 (completion of intervention)

    Measure of children's self-regulation that targets affective lability, intensity, valence, and flexibility. The total scores range from 24 to 96, with higher scores indicating better emotion regulation.

  2. Coping with Children's Negative Emotions Scale

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

    Measure of parental coping styles in response to children's negative emotions. It consists of six subscales: Distress Reactions, Punitive Reactions, Expressive Encouragement, Emotion-Focused Reactions, Problem-Focused Reactions, and Minimization Reactions. The scores of each subscale range from 12 to 84, with higher scores indicating a greater likelihood of the parent engaging the type of response measured by that subscale.

  3. Parenting Stress Index

    Time frame: T1 (baseline), T3 (completion of intervention)

    Measure of potential dysfunctional parent-child relationships and severity of parenting stress. Higher scores indicate higher levels of stress.

  4. Parent-Child Observed Interaction Coding

    Time frame: T1 (baseline), T3 (completion of intervention)

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

Other outcomes

  1. Beck Depression Inventory-II

    Time frame: T1 (baseline), T3 (completion of intervention)

    Measure of parental depression. The total scores range from 0 to 63, with higher scores indicating more severe symptoms.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Promoting Emotional Development Among Young Children Facing Adversity: An Effectiveness Implementation Study in St. Louis Schools

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 18, 2023
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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