NCT07281365

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

Proof-of-Concept Trial of an Emotion Regulation and Executive Functioning Intervention for SITBs in Children

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Not accepted

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

Detailed description

In Phase 1 of the study (Aim 1), the investigators will iteratively design an intervention for preadolescent SITBs through a step-by-step process using frameworks for systematically developing and adapting interventions (Wingood et al., 2008; Bartholomew et al., 1998). The design process will incorporate user-centered design methods, whereby multisectoral experts and end-users (i.e., therapists and families) will participate in the design process to maximize the intervention's dissemination and implementation potential. In Phase 2 of the study (Aims 2 and 3), the investigators will conduct a pilot randomized controlled trial (RCT) of the intervention, with a treatment as usual (TAU) comparator, in 52 preadolescents ages 7-12. Aim 2 will evaluate engagement (primary outcome), feasibility, acceptability, and implementation outcomes for the intervention and study procedures. Aim 3 will be to collect preliminary evidence to explore superiority of the SITB intervention to TAU in reducing SITBs and engaging the target mechanisms of EF and emotion regulation. In Phase 1, the investigators will use mixed methods approaches and user-centered design principles to iteratively develop the preadolescent SITB intervention. Through a needs assessment, the investigators will use an exploratory sequential qualitative--\> quantitative mixed methods design, whereby qualitative interviews with therapists will inform the development of a quantitative survey assessing needs and experiences of therapists treating preadolescents with SITBs. Results from the therapist assessment will be integrated with findings from qualitative interviews with preadolescents and caregiversto further inform initial decisions about core functions and specific components of the intervention. During a pre-testing phase utilizing a concurrent mixed methods approach, therapists and preadolescents/families will participate in think-aloud design sessions to provide quantitative and qualitative feedback about rough intervention prototypes. An initial draft of the intervention will then be produced and reviewed by a group of experts, resulting in a second draft of the intervention and therapist training and consultation procedures. A single-arm, pilot feasibility trial of the intervention with 9 preadolescents (ADAPT-ITT Step 8, Part 1) will inform adaptations to the intervention, therapist training, and trial procedures. Phase 2 will involve training therapists in the intervention, using procedures and materials refined during the pilot trial, followed by a RCT with a TAU control condition with 52 preadolescents (ADAPT-ITT Step 8, Part 2). The trial will be powered to detect differences in engagement between conditions (primary outcome) and establish feasibility and acceptability, while also evaluating preliminary efficacy outcomes and EF change mechanisms.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2025-12-15
• Last updated: 2025-12-15