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

NCT03112265 | Completed DMC

• 1 other identifier: 313704
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety; Depression; Trauma; Behavior Problems

Keywords

anxiety; depression; trauma; behavior problems; evidence-based treatments; manualized treatments; cognitive-behavioral therapy; youth; mental health; self-regulation; neuroimaging

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• 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

• Change from Baseline Granularity Task at End of Treatment

  Change over time from Day 1 to end of treatment, assessed up to 40 weeks

• 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

• 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

Other Outcomes (4)

• 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

• 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

• 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

Study Arms (2)

Child STEPS

EXPERIMENTAL

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).

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

Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Treatment as usual

Interventions

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

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.

Also known as: MATCH, MATCH - ADTC

Child STEPS

Monitoring and Feedback System OTHER

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.

Also known as: MFS

Child STEPS

Treatment as usual BEHAVIORAL

Treatment in the UC condition will use the procedures therapists and their supervisors consider appropriate and believe to be effective.

Also known as: Usual Care, UC

Usual Care

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• enrolled in grades 3-7
• have a primary clinical problem in the areas of anxiety, depression, conduct, or posttraumatic stress
• 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.

You may not qualify if:

• Mental retardation
• Pervasive developmental disorder
• Eating disorder
• children for whom attention problems or hyperactivity are the primary referral concern
• 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).

Sponsors & Collaborators

• Harvard University: lead

Study Sites (1)

Harvard University

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (2)

• 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.

  PMID: 22065252 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Wounds and Injuries; Mental Disorders; Psychological Well-Being; Self-Control

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction; Social Behavior

Study Officials

• John R. Weisz, PhD

  Harvard University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Primary Investigator

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 13, 2017
• Study Start: January 1, 2015
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: March 10, 2021

Record last verified: 2021-03

Locations

US (1)