NCT03112265

Using Neuroimaging to Understand Children's Mental Health and Treatment Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Harvard University · Academic / Other
• Sex: All
• Age: 7 Years – 13 Years
• Healthy volunteers: Accepted

Summary

The study will compare the impact of Child STEPs versus usual school-based therapy on neural and companion behavioral measures of self-regulation.

Detailed description

This project will implement and evaluate the Child STEPs treatment approach as compared to "treatment as usual" (known as Usual Care or UC) through a randomized controlled trial (RCT) at eight K-8 public schools. The STEPs model has two components: (1) a modular protocol that combines 33 modules-i.e., descriptions of common elements within evidence-based therapies for anxiety, depression, post-traumatic stress, and conduct problems; and (2) a web-based system for monitoring student responses to treatment and providing weekly feedback to therapists to guide their selection and sequencing of the STEPs modules. The project will examine: (a) whether self-regulation skills at baseline are associated with baseline patterns of mental health and school problems; (b) whether self-regulation skills at baseline predict degree of improvement during treatment; (c) whether self-regulation skills improve from pre-to post treatment, and whether extent of this improvement differs by treatment condition; and (d) whether self-regulation improvement (from pre-to-post treatment) mediates the long-term benefit of treatment.

Conditions

• Anxiety
• Depression
• Trauma
• Behavior Problems

Interventions

Type	Name	Description
BEHAVIORAL	Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems	MATCH-ADTC is designed for children aged 6-15. Unlike most evidence-based treatments (EBTs), which focus on single disorder categories (e.g., anxiety only), MATCH is designed for multiple disorders and problems encompassing anxiety, depression, post-traumatic stress, and disruptive conduct, including the conduct problems associated with ADHD. MATCH is composed of 33 modules-i.e., specific treatment procedures derived from decades of research on EBTs. The various modules can be organized and sequenced flexibly to tailor treatment to each child's characteristics and needs.
OTHER	Monitoring and Feedback System	For each child, the web-based MFS system provides weekly monitoring of the MATCH modules used and the child's treatment response, in two forms (a) changes on the Behavior and Emotions Survey and (b) changes in severity of the top treatment concerns identified by youths and caregivers. At the end of treatment, the MFS provides a complete record of modules used, and child treatment response, across all the weeks of treatment.
BEHAVIORAL	Treatment as usual	Treatment in the UC condition will use the procedures therapists and their supervisors consider appropriate and believe to be effective.

Timeline

• Start date: 2015-01-01
• Primary completion: 2020-07-31
• Completion: 2020-07-31
• First posted: 2017-04-13
• Last updated: 2021-03-10

Locations

1 site across 1 country: United States