Emotion Regulation Intervention for Self-Harm in Children
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Are You a Good Fit for This Trial?
This trial is for children ages 7-12 who have had self-injurious thoughts or behaviors in the past month, can attend weekly sessions (in-person or online), have a caregiver able to participate, and have an estimated verbal IQ of at least 70.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Preadolescent SITB Intervention
- Treatment as usual (TAU)
Trial Overview
The study compares a new outpatient program focused on emotion regulation and executive functioning with standard treatment. Children are assigned to either the usual care group or the new intervention group for about 6-12 weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Experimental intervention for preadolescent SITBs targeting executive functioning, emotion regulation, and other SITB risk factors
Treatment as Usual provided by outpatient mental health therapist
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
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