405 Participants Needed

THRIVE Intervention for Childhood Mental Disorder

Recruiting at 1 trial location
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

How does the THRIVE treatment for childhood mental disorder differ from other treatments?

The THRIVE treatment, also known as Lynparza or Olaparib, is unique because it is primarily used for cancer treatment, specifically targeting cancer cells by inhibiting a protein involved in DNA repair. This mechanism is different from typical treatments for childhood mental disorders, which often involve antipsychotics or behavioral therapies.12345

What is the purpose of this trial?

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.

Research Team

JL

Joan Luby, PhD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for children aged 3-7 who may be struggling with mental health issues, as indicated by their teachers or parents, but are not diagnosed with autism or major neurological disorders. Children already in weekly therapy are excluded.

Inclusion Criteria

Near the clinical threshold on the Teacher or Parent Report Form

Exclusion Criteria

Autism
I am currently in weekly individual or family therapy.
I have a significant brain or nerve condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

The THRIVE intervention is conducted over 6-8 weeks via video conference or within the school setting, compared to the Parenting Wisely online program.

6-8 weeks
Weekly sessions (virtual or in-person)

Follow-up

Participants are monitored for behavioral and socio-emotional outcomes, as well as parenting stress and depression.

12 weeks
1 visit (virtual or in-person)

Treatment Details

Interventions

  • Parenting Wisely
  • THRIVE
Trial Overview The study tests THRIVE, a caregiver-child intervention delivered via video conference or at school, against an online parenting course (Parenting Wisely). It also compares two ways of supporting therapists: ongoing coaching versus minimal post-training support.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: THRIVE Low CoachedExperimental Treatment1 Intervention
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.
Group II: THRIVE CoachedExperimental Treatment1 Intervention
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.
Group III: Parenting WiselyActive Control1 Intervention
Online asynchronous parenting training that parents will complete independently.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

References

Long-acting Injectable Risperidone Use in an 11-Years-Old Bipolar Child. [2022]
2.China (Republic : 1949- )pubmed.ncbi.nlm.nih.gov
Aripiprazole improves social interaction in Taiwanese children with pervasive developmental disorder. [2015]
Medication and parent training in children with pervasive developmental disorders and serious behavior problems: results from a randomized clinical trial. [2022]
High-risk psychotropic medications for US children with trauma sequelae. [2020]
A 1-year open-label trial of olanzapine in school-age children with schizophrenia. [2021]
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