Harvard University
Cambridge, Massachusetts, 02138, United States
NCT Number: NCT03112265
The study will compare the impact of Child STEPs versus usual school-based therapy on neural and companion behavioral measures of self-regulation.
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Notify Me7 year–13 year
All sexes
Interventional
Not applicable
Cambridge, Massachusetts, 02138, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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 names: MATCH, MATCH - ADTC
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.
Other names: MFS
Treatment in the UC condition will use the procedures therapists and their supervisors consider appropriate and believe to be effective.
Other names: Usual Care, UC
Time frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Time frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Time frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Time frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Time frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Time frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Time frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Time frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Time frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Time frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Harvard University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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