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

NCT ID: NCT07281365

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-05-31
• Study Completion Date: 2028-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Preadolescent SITB Intervention

Experimental intervention for preadolescent SITBs targeting executive functioning, emotion regulation, and other SITB risk factors

Group Type: EXPERIMENTAL

Preadolescent SITB Intervention

Intervention Type: BEHAVIORAL

Experimental intervention developed with end-users and experts to target emotion regulation, executive functioning, and other risk factors for SITBs in preadolescents

Treatment as Usual (TAU)

Treatment as Usual provided by outpatient mental health therapist

Group Type: ACTIVE_COMPARATOR

Treatment as usual (TAU)

Intervention Type: BEHAVIORAL

Typical interventions Outpatient therapist would provide to a preadolescent with SITBs, based on their clinical judgement

Interventions

Treatment as usual (TAU)

Typical interventions Outpatient therapist would provide to a preadolescent with SITBs, based on their clinical judgement

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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
• ability to attend baseline and 12-week assessments in-person.
• estimated verbal IQ of 70 or greater

Exclusion Criteria

• 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
• ward of the state

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

R34MH135963

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-1783

Identifier Type: -

Identifier Source: org_study_id