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

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

In Stage 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 Stage 2 of the study (Aims 2 and 3), the new intervention will be evaluated using a quasi-experimental, pre-post implementation design including 52 preadolescents and caregiver(s), recruited through the CHCO emergency department (ED) at the Anschutz Campus.

In Stage 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, intervention development trial with 6 preadolescents will inform adaptations to the intervention, therapist training, and trial procedures.

In Stage 2, the investigators will evaluate the feasibility and acceptability of the study methods and intervention, implementation, and changes in SITB and mental health outcomes using a quasi-experimental, pre-post implementation design (ADAPT-ITT Step 8, Part 2). The trial will have two phases. In Phase 1 of the trial (pre-implementation, months 1-6), enrolled participants will receive treatment as usual (TAU); in Phase 2 of the trial (post-implementation, months 7-13), enrolled participants will receive the new intervention. All treatment will be delivered at the Crisis Clinic at Children's Hospital Colorado, which provides short-term (i.e., 6-12 session) outpatient crisis intervention to youth referred from the ED. Clinicians (up to N = 16) will be recruited from the Crisis Clinic to participate. During Phase 1, clinicians will provide treatment using their typical clinical practice. Prior to Phase 2, clinicians will receive training in the new intervention and will receive monthly consultation support from the developers throughout the implementation phase. Aim 2 will evaluate feasibility, acceptability, and implementation outcomes for the intervention and study procedures. Aim 3 will be to collect preliminary evidence to explore changes in SITBs, hypothesized target mechanisms of EF and emotion regulation, and mental health symptoms relative to TAU.

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 post-treatment 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