Clinical trial NCT06139874: Thrive Intervention in Schools
Official title: Promoting Emotional Development Among Young Children Facing Adversity: An Effectiveness Implementation Study in St. Louis Schools
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Childhood Mental Disorder
Keywords: Preschool
Parent-Child Relationship
Emotion Development
Therapy
Prevention
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 405
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Child Behavior Checklist
timeFrame: T1 (baseline), T2 (halfway through intervention), T3 (completion of intervention) and T4 (12 weeks post intervention)
Secondary outcomes:
measure: The Emotion Regulation Checklist
timeFrame: T1 (baseline), T3 (completion of intervention)
measure: Coping with Children's Negative Emotions Scale
timeFrame: T1 (baseline), T2 (halfway through intervention), T3 (completion of intervention)
measure: Parenting Stress Index
timeFrame: T1 (baseline), T3 (completion of intervention)
measure: Parent-Child Observed Interaction Coding
timeFrame: T1 (baseline), T3 (completion of intervention)
Other outcomes:
measure: Beck Depression Inventory-II
timeFrame: T1 (baseline), T3 (completion of intervention)
Locations:
city: St. Louis
country: United States
facility: Early Emotional Development Program
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Joan Luby, PhD
role: PRINCIPAL_INVESTIGATOR
References: