Pilot Trial of an Emotion Regulation and Executive Functioning Intervention for Self-Injurious Th… (NCT07281365) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pilot Trial of an Emotion Regulation and Executive Functioning Intervention for Self-Injurious Thoughts and Behaviors (SITBs) in Children
United States52 participantsStarted 2026-12
Plain-language 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
Who can participate
Age range
7 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.