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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 2026-05-14

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. Does the newer intervention lead to better engagement of families in treatment compared to treatment as usual (TAU)?
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 compared to TAU?

Preadolescent participants with SITBs and their families will be randomized to either the new intervention or TAU, which will consist of the typical interventions the study therapist would use for preadolescents with SITBs. 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 a \~weekly, outpatient intervention lasting around 3-4 months
3. Complete additional assessments at mid-treatment, 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
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

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

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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