Thrive Intervention in Schools

Childhood Mental Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06139874
• Other study ID #: 202306092
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: November 10, 2028

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 405
• Est. completion date: November 10, 2028
• Est. primary completion date: November 10, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Mental Disorder
• Mental Disorders

Intervention

Behavioral:
• THRIVE
Early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention.
• Parenting Wisely
Online asynchronous parenting program.

Locations

Country	Name	City	State
United States	Early Emotional Development Program	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Beck Depression Inventory-II	Measure of parental depression. The total scores range from 0 to 63, with higher scores indicating more severe symptoms.	T1 (baseline), T3 (completion of intervention)
Primary	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	The Emotion Regulation Checklist	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.	T1 (baseline), T3 (completion of intervention)
Secondary	Coping with Children's Negative Emotions Scale	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.	T1 (baseline), T2 (halfway through intervention), T3 (completion of intervention)
Secondary	Parenting Stress Index	Measure of potential dysfunctional parent-child relationships and severity of parenting stress. Higher scores indicate higher levels of stress.	T1 (baseline), T3 (completion of intervention)
Secondary	Parent-Child Observed Interaction Coding	Objective ratings of the parent-child relationship functioning, parent emotion learning and child emotional competence.	T1 (baseline), T3 (completion of intervention)

External Links

•   Early Emotional Development Program Website