Clinical trial NCT03112265: Using Neuroimaging to Understand Children's Mental Health and Treatment Outcomes
Official title: Using Neuroimaging to Understand Children's Mental Health and Treatment Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Harvard University
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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 clinically elevated problem levels on the Internalizing, Externalizing, Anxious-Depressed, Withdrawn-Depressed, Aggressive Behavior, or Rule-Breaking Behavior scales of the Child Behavior Checklist or Youth Self-Report or on the UCLA Post-Traumatic Stress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

Primary outcomes:
measure: Change from Baseline Emotion Regulation Task at End of Treatment
timeFrame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
measure: Change from Baseline Emotional Go/No-Go Task at End of Treatment
timeFrame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Secondary outcomes:
measure: Change from Baseline Attentional Bias Task at End of Treatment
timeFrame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
measure: Change from Baseline Granularity Task at End of Treatment
timeFrame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
measure: Change from Baseline Behavior Rating Inventory of Executive Function (BRIEF) at End of Treatment
timeFrame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
measure: Change from Baseline Early Adolescent Temperament Questionnaire Revised (EATQ-R) at End of Treatment
timeFrame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Other outcomes:
measure: Change from Baseline Coping with Children's Negative Emotions Scale (CCNES) at End of Treatment
timeFrame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
measure: Change from Baseline Parenting Stress Index-Short Form (PSI-SF) at End of Treatment
timeFrame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
measure: Change from Baseline Family Adaptability and Cohesion Scale IV (FACES-IV) at End of Treatment
timeFrame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
measure: Change from Baseline Five Minute Speech Sample (FMSS) at End of Treatment
timeFrame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Locations:
city: Cambridge
country: United States
facility: Harvard University
state: Massachusetts
Study officials:
affiliation: Harvard University
name: John R. Weisz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.