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

NCT07281365 | Not Yet Recruiting DMC

• 2 other identifiers: 24-1783R34MH135963
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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. 1.Does the newer intervention lead to better engagement of families in treatment compared to treatment as usual (TAU)?
2. 2.Is the new intervention feasible, acceptable, and appropriate?
3. 3.Does the new intervention lead to more improvements in SITBs, mental health symptoms, and treatment targets compared to TAU?
4. 4.Complete an initial baseline assessment to determine eligibility and assess SITBs, mental health symptoms, executive functioning, and emotion regulation
5. 5.Participate in a \~weekly, outpatient intervention lasting around 3-4 months
6. 6.Complete additional assessments at mid-treatment, post-treatment, and 3-month follow-up
7. 7.Participate in an interview sharing their perceptions of the intervention

Conditions

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

Keywords

Preadolescents; Children; Self-Injury; Suicidal ideation and behavior; Randomized controlled trial; Feasibility

Outcome Measures

Primary Outcomes (7)

• Treatment Engagement

  Number of treatment sessions completed at post-treatment

  From enrollment to post-treatment at 12 weeks

• Feasibility of Retention

  % participants completing treatment (benchmark =≥ 80% participants considered treatment completers)

  From enrollment to the end of treatment at 12 weeks

• Feasibility of recruitment

  % recruitment targets met (benchmark = 52 preadolescents randomized to receive treatment)

  Calculated at enrollment

• Feasibility of Measurement

  % participants at each timepoint completing measures (target = ≥ 80% at each timepoint).

  From enrollment to follow-up at 24 weeks

• Perceived acceptability of intervention

  The Acceptability of Intervention Measure (AIM; Weiner et al., 2017) will be completed by preadolescents, caregivers, and therapists. The AIM is a 4-item measure assessing the extent to which stakeholders believe an intervention to be acceptable. Items are rated from 1 ("completely disagree") to 5 ("completely agree"), with higher scores indicating greater acceptability. The acceptability benchmark for all reporters is set at a mean score of 4 or greater.

  From enrollment to the end of treatment at 12 weeks

• Perceived Feasibility of Intervention

  The Feasibility of Intervention Measure (FIM; Weiner et al., 2017) will be completed by preadolescents, caregivers, and therapists. The FIM is a 4-item measures assessing the extent to which stakeholders believe an intervention to be feasible. Items are rated from 1 ("completely disagree") to 5 ("completely agree"), with higher scores indicating greater feasibility. The feasibility benchmark for all reporters is set at a mean score of 4 or greater.

  From enrollment to the end of treatment at 12 weeks

• Perceived Appropriateness of Intervention

  The Intervention Appropriateness Measure (IAM; Weiner et al., 2017) will be completed by preadolescents, caregivers, and therapists. The IAM is a 4-item measure assessing the extent to which stakeholders believe an intervention or to be appropriate. Items are rated from 1 ("completely disagree") to 5 ("completely agree"), with higher scores indicating greater appropriateness. The appropriateness benchmark for all reporters is set at a mean score of 4 or greater.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (3)

• Suicidal Ideation Intensity

  From enrollment to 3-month follow-up at 24 weeks

• Readmission/Admission Rates

  From enrollment to 3-month follow-up at 24 weeks

• Non-Suicidal Self-Injury

  From enrollment to 3-month follow-up at 24 weeks

Other Outcomes (8)

• Anxiety Symptoms

  From enrollment to 3-month follow-up at 24 weeks

• Depression Symptoms

  From enrollment to 3-month follow-up at 24 weeks

• Disruptive Behavior Symptoms

  From enrollment to 3-month follow-up at 24 weeks

Study Arms (2)

Preadolescent SITB Intervention

EXPERIMENTAL

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

Behavioral: Preadolescent SITB Intervention

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Treatment as Usual provided by outpatient mental health therapist

Behavioral: Treatment as usual (TAU)

Interventions

Treatment as usual (TAU) BEHAVIORAL

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

Treatment as Usual (TAU)

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

Preadolescent SITB Intervention

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• University of Colorado, Denver: lead

MeSH Terms

Conditions

Self-Injurious Behavior; Suicidal Ideation; Behavior; Emotional Regulation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Suicide; Self-Control; Social Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 15, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF