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

President and Fellows of Harvard College

Status: Completed

Conditions: Behavior Problems; Trauma; Depression; Anxiety

Treatments: Behavioral: Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems; Other: Monitoring and Feedback System; Behavioral: Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT03112265

313704

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 7 to 13 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. enrolled in grades 3-7
2. have a primary clinical problem in the areas of anxiety, depression, conduct, or posttraumatic stress
3. clinically elevated problem levels on the Internalizing, Externalizing, Anxious-Depressed, Withdrawn-Depressed, Aggressive Behavior, or Rule-Breaking Behavior scales of the Child Behavior Checklist or Youth Self-Report or on the UCLA Post-Traumatic Stress Disorder Reaction Index.

Exclusion criteria

1. Mental retardation
2. Pervasive developmental disorder
3. Eating disorder
4. children for whom attention problems or hyperactivity are the primary referral concern
5. active psychosis and/or a suicide attempt in the previous year

To participate in the two neuroimaging tasks (Emotion Regulation Task; Emotional Go/No Go Task), participants must be healthy (no major medical illness), right-handed, fluent in English, have no history of neurological impairment (including but not limited to history of loss of consciousness for great than 20 minutes, seizures, stroke, etc.), have normal or corrected to normal vision, and have no contra-indications or risk factors for MRI research (such as braces or metal implants).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

100 participants in 2 patient groups

Child STEPS

Experimental group

Description:

Child STEPs includes (1) a treatment protocol, Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct Problems (MATCH-ADTC), and (2) a youth monitoring and feedback system (MFS).

Treatment:

Other: Monitoring and Feedback System

Behavioral: Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems

Usual Care

Active Comparator group

Description:

Treatment in the UC condition will use the procedures therapists and their supervisors consider appropriate and believe to be effective, and researchers will not influence their work.

Treatment:

Behavioral: Treatment as usual