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NOT YET RECRUITING
NCT07281365
NA

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

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

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

BEHAVIORAL

Treatment as usual (TAU)

Typical interventions Outpatient therapist would provide to a preadolescent with SITBs, based on their clinical judgement

BEHAVIORAL

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