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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112265
• Other study ID #: 313704
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: July 31, 2020

Study information

• Verified date: March 2021
• Source: Harvard University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

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 clinically elevated problem levels on the Internalizing, Externalizing, Anxious-Depressed, Withdrawn-Depressed, Aggressive Behavior, or Rule-Breaking Behavior scales of the Child Behavior Checklist or Youth Self-Report or on the UCLA Post-Traumatic Stress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).

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Harvard University	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Harvard University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Chorpita, B.F., & Weisz, J.R. (2009). Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH-ADTC). Satellite Beach, FL: PracticeWise, LLC.

Weisz JR, Chorpita BF, Palinkas LA, Schoenwald SK, Miranda J, Bearman SK, Daleiden EL, Ugueto AM, Ho A, Martin J, Gray J, Alleyne A, Langer DA, Southam-Gerow MA, Gibbons RD; Research Network on Youth Mental Health. Testing standard and modular designs for psychotherapy treating depression, anxiety, and conduct problems in youth: a randomized effectiveness trial. Arch Gen Psychiatry. 2012 Mar;69(3):274-82. doi: 10.1001/archgenpsychiatry.2011.147. Epub 2011 Nov 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline Coping with Children's Negative Emotions Scale (CCNES) at End of Treatment		Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Other	Change from Baseline Parenting Stress Index-Short Form (PSI-SF) at End of Treatment		Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Other	Change from Baseline Family Adaptability and Cohesion Scale IV (FACES-IV) at End of Treatment		Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Other	Change from Baseline Five Minute Speech Sample (FMSS) at End of Treatment		Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Primary	Change from Baseline Emotion Regulation Task at End of Treatment		Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Primary	Change from Baseline Emotional Go/No-Go Task at End of Treatment		Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Secondary	Change from Baseline Attentional Bias Task at End of Treatment		Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Secondary	Change from Baseline Granularity Task at End of Treatment		Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Secondary	Change from Baseline Behavior Rating Inventory of Executive Function (BRIEF) at End of Treatment		Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Secondary	Change from Baseline Early Adolescent Temperament Questionnaire Revised (EATQ-R) at End of Treatment		Change over time from Day 1 to end of treatment, assessed up to 40 weeks