Pilot Trial of an Emotion Regulation and Executive Functioning Intervention for Self-Injurious Thoughts and Behaviors (SITBs) in Children

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

NCT Number	NCT07281365
Lead Sponsor	University of Colorado, Denver Collaborators: National Institute of Mental Health (NIMH)
Conditions	Self-injury, Suicidal Ideation and Behavior, Executive Functioning, Emotion Regulation
Enrollment	52 participants
Start Date	2026-12
Primary Completion	2028-05 (estimated)
Study Completion	2028-05 (estimated)
Updated on ClinicalTrials.gov	2026-07-29