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Pilot Trial of an Emotion Regulation and Executive Functioning Intervention for Self-Injurious Thoughts and Behaviors (SITBs) in Children
Sponsor: University of Colorado, Denver
Summary
The goal of this study is to develop and test an outpatient intervention for preadolescents (ages 7-12) with self-injurious thoughts and behaviors (SITBs). The main questions it aims to answer are: 1. Are the recruitment targets and study design feasible? 2. Is the new intervention feasible, acceptable, and appropriate? 3. Does the new intervention lead to more improvements in SITBs, mental health symptoms, and treatment targets relative to treatment as usual (TAU)? In Phase 1 (pre-implementation, months 1-6), enrolled preadolescent and caregiver dyads will receive TAU. In Phase 2 (post-implementation, months 7-13), enrolled dyads will receive the newly-developed SITB intervention. Participants will be recruited through referrals from the psychiatric emergency department at Children's Hospital Colorado. Participants will: 1. Complete an initial baseline assessment to determine eligibility and assess SITBs, mental health symptoms, executive functioning, and emotion regulation 2. Participate in an intervention lasting 6-12 weeks, including weekly or biweekly sessions 3. Complete additional assessments at post-treatment and 3-month follow-up 4. Participate in an interview sharing their perceptions of the intervention
Official title: Proof-of-Concept Trial of an Emotion Regulation and Executive Functioning Intervention for SITBs in Children
Key Details
Gender
All
Age Range
7 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2026-12
Completion Date
2028-05
Last Updated
2026-07-29
Healthy Volunteers
No
Interventions
Treatment as usual (TAU)
Typical interventions Outpatient therapist would provide to a preadolescent with SITBs, based on their clinical judgement
Preadolescent SITB Intervention
Experimental intervention developed with end-users and experts to target emotion regulation, executive functioning, and other risk factors for SITBs in preadolescents
Locations (1)
Children's Hospital Colorado
Aurora, Colorado, United States