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

NCT07281365 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-07-29

No results posted yet for this study

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

Conditions

  • Self-injury
  • Suicidal Ideation and Behavior
  • Executive Functioning
  • Emotion Regulation

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2028-05-31
Completion
2028-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07281365 on ClinicalTrials.gov