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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

7 Years - 12 Years

Healthy Volunteers

Not accepted

Interventions

• Treatment as usual (TAU) — BEHAVIORAL
  Typical interventions Outpatient therapist would provide to a preadolescent with SITBs, based on their clinical judgement
• Preadolescent SITB Intervention — BEHAVIORAL
  Experimental intervention developed with end-users and experts to target emotion regulation, executive functioning, and other risk factors for SITBs in preadolescents

Study Details

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

Key Dates

First listed

Dec 15, 2025

Start date

Dec 31, 2026

Status verified

Jul 2026

Primary completion

May 31, 2028

Completion

May 31, 2028

Study Design

Enrollment

52 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Preadolescent SITB Intervention
  Experimental intervention for preadolescent SITBs targeting executive functioning, emotion regulation, and other SITB risk factors
• Active Comparator: Treatment as Usual (TAU)
  Treatment as Usual provided by outpatient mental health therapist

Primary Outcome Measure

Feasibility of recruitment [ Time Frame: Calculated at enrollment ]

Locations (1)

Find similar trials in Aurora, CO

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