CompletedNot Applicable

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

United States100 participantsStarted 2015-01

Plain-language summary

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

Age range7 Years – 13 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 clinically elevated problem levels on the Internalizing, Externalizing, Anxious-Depressed, Withdrawn-Depressed, Aggressive Behavior, or Rule-Breaking Behavior scales of the Child Behavior Checklist or Youth Self-Report or on the UCLA Post-Traumatic Stress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

✕. 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

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

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

NCT IDNCT03112265

SponsorHarvard University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-31