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

University of Colorado Denver (CU Denver)

Status: Begins enrollment in 2 months

Conditions: Suicidal Ideation and Behavior; Executive Functioning; Emotion Regulation; Self-injury

Treatments: Behavioral: Treatment as usual (TAU); Behavioral: Preadolescent SITB Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07281365

24-1783

R34MH135963 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

Preadolescent SITB Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Preadolescent SITB Intervention

Treatment as Usual (TAU)

Active Comparator group

Description:

Treatment as Usual provided by outpatient mental health therapist

Treatment:

Behavioral: Treatment as usual (TAU)