Pilot Trial of an Emotion Regulation and Executive Functioning Intervention for Self-Injurious Thoughts and Behaviors (SITBs) in Children
Starting soon · Not applicable
Conditions studied: Self-injury, Suicidal Ideation and Behavior, Executive Functioning, Emotion Regulation
In brief
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
Key facts
- Study ID
- NCT07281365
- Run by
- University of Colorado, Denver
- People needed
- 52
- Starts
- 2026-12-01
- Expected to finish
- 2028-05-01
- Last updated by the study team
- 2026-07-29
Who can join
Age: 7 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- between the ages of 7-12
- at least one caregiver/legal guardian able to participate (more permitted)
- experienced at least one episode of SITBs within the last month
- ability to attend weekly sessions in-person or via telehealth
- ability to attend baseline and post-treatment assessments in-person.
- estimated verbal IQ of 70 or greater
You may not qualify if…
- symptoms interfering with ability to participate in assessments/therapy (i.e., psychosis)
- estimated verbal IQ<70 or previous diagnosis of intellectual development disorder
- requiring inpatient psychiatric stabilization or high-intensity intervention to prevent hospitalization
- active substance use
- ward of the state
Where it is running
- Children's Hospital Colorado — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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