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

Depression Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anxiety
• Behavior Problems
• Depression
• Problem Behavior
• Trauma

• NCT number: NCT03112265
• Study type: Interventional
• Source: Harvard University
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Completion date: July 31, 2020