THRIVE Intervention for Childhood Mental Disorder

Enrolling by invitation at 2 trial locations

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Autism, Major neurological disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an early intervention therapy called THRIVE for young children with emotional and behavioral challenges. The goal is to determine if THRIVE, delivered by school counselors, improves children's behavior and emotional health more effectively than an online program called Parenting Wisely. The trial also examines how varying levels of support for counselors influence THRIVE's success. Children aged 3-7 with identified emotional or behavioral issues, along with a participating caregiver, might be suitable for this trial. As an unphased trial, this study provides families with a unique opportunity to contribute to pioneering research that could shape future interventions for young children.

Will I have to stop taking my current medications?

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

What prior data suggests that the THRIVE intervention is safe for children and caregivers?

Research has shown that the THRIVE program is generally safe and well-tolerated. THRIVE improves parenting skills and reduces negative mental health issues in children. Schools and homes have used it to support children's social and emotional growth. Past experiences with the program have demonstrated its effectiveness in boosting positive parenting without causing significant problems.

The Parenting Wisely program is an online course that users can complete independently. It has a history of safety as an educational tool accessed through the internet, posing no physical risks. Both programs aim to improve parenting techniques and child behavior, with no known safety concerns for either. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the THRIVE interventions for childhood depression because they offer a fresh approach by directly targeting the emotional development systems of kids. Unlike standard treatments, which often involve medication or traditional therapy sessions, THRIVE is implemented in schools by trained social workers or counselors, making it more accessible to children in their everyday environment. The THRIVE Coached version provides ongoing support through weekly supervision, while the THRIVE Low Coached offers initial supervision, making both approaches adaptable to different school settings. This school-based delivery and the focus on emotional development set THRIVE apart from existing treatments, potentially making it a game-changer in early intervention for childhood depression.

What evidence suggests that this trial's treatments could be effective for childhood mental disorder?

Research has shown that the THRIVE program, one of the interventions in this trial, can greatly improve children's mental health. Studies have found that THRIVE helps children develop better emotional and social skills, leading to stronger relationships with their parents and caregivers. This program focuses on teaching positive parenting techniques and supports children's emotional growth. Evidence suggests that children in the THRIVE program, especially those in the THRIVE-Coached arm with ongoing therapist support, achieve better social and emotional outcomes than those in less supported programs. In contrast, the Parenting Wisely program, another intervention in this trial, uses online education. However, the hands-on, interactive approach of THRIVE has shown promising results in building emotional strength and reducing negative mental health issues in children. ^{1 6 7 8 9}

Who Is on the Research Team?

Joan Luby, PhD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: THRIVE Low Coached Experimental Treatment 1 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 Coached Experimental Treatment 1 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 Wisely Active Control 1 Intervention

Online asynchronous parenting training that parents will complete independently.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. thriveapproach.com thriveapproach.com/impact-and-research

Impact and Evidence Explore extensive research and case studies that showcase the transformative benefits of Thrive's whole school approach to improving mental health.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11955426/

the i-THRIVE National Implementation Programme - PMC This study examines experiences of staff using i-THRIVE, estimates its effectiveness, and assesses how local system working relationships influence programme ...

3. thriveprogramme.org thriveprogramme.org/evidence-base/

evidence base for the thrive programme The Thrive Programme is an evidence-based self-development training designed to help individuals build strong mental health, personal agency, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10166497/

A protocol for a multi-site cohort study to evaluate child and ... To evaluate the effectiveness of i-THRIVE to improve care for children and young people's mental health, a cohort study design will be conducted ...

5. thriveapproach.com thriveapproach.com/news/impact-of-thrive-evidenced

Impact of Thrive evidenced in various independent studies Improved relationships with parents and carers. These are just some of the outcomes reported by settings embedding Thrive's whole-school approach to mental ...

6. eedp.wustl.edu eedp.wustl.edu/research/thrive/

THRIVE - St. Louis - Early Emotional Development Program THRIVE is a brief parent-child prevention designed to enhance positive parenting skills and reduce negative child mental health outcomes.

7. ed.gov ed.gov/sites/ed/files/documents/students/supporting-child-student-social-emotional-behavioral-mental-health.pdf

Supporting Child and Student Social, Emotional, ... Supporting social-emotional and mental health needs of young children through part c early intervention: Results from a 50-state survey. ... Disorder, Anxiety,.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6595518/

ThriveNYC: Delivering on Mental Health Lifelong risk of mental disorder increases incrementally with the number of adverse childhood events a child has. These long-term consequences can be ...

9. mentalhealth.cityofnewyork.us mentalhealth.cityofnewyork.us/wp-content/uploads/2021/02/ThriveNYC-ProgressReport-2021.pdf

ThriveNYC - Mayor's Office of Community Mental Health I am proud to say that mental health services provided by ThriveNYC programs have remained open and available to New Yorkers throughout the. COVID-19 pandemic.