About 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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Treatment as usual (TAU)
- Preadolescent SITB Intervention
Treatment groups
Sponsors and collaborators
University of Colorado, Denver
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator