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. 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

Study Overview

• Status: Not yet recruiting
• Conditions: Emotion Regulation; Executive Functioning; Suicidal Ideation and Behavior; Self-injury
• Intervention / Treatment: Behavioral: Preadolescent SITB Intervention; Behavioral: Treatment as usual (TAU)

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preadolescent SITB Intervention; Experimental intervention for preadolescent SITBs targeting executive functioning, emotion regulation, and other SITB risk factors	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
Active Comparator: Treatment as Usual (TAU); Treatment as Usual provided by outpatient mental health therapist	Behavioral: Treatment as usual (TAU); Typical interventions Outpatient therapist would provide to a preadolescent with SITBs, based on their clinical judgement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicidal Ideation Intensity	Measured using the Columbia Suicide and Self Injury Severity Rating Scale (C-SSRS; Posner et al., 2011), a brief interview that consists of sections that assess: suicidal ideation, ideation intensity, and suicidal behavior. The C-SSRS has strong convergent validity, sensitivity to change, predictive and incremental validity, and good internal consistency.	From enrollment to 3-month follow-up at 24 weeks
Readmission/Admission Rates	Readmission/admission rates to the psychiatric ED or inpatient psychiatric hospitalization will be evaluated via caregiver report on the Brief form of the Services Assessment for Children and Adolescents (SACA; Horwitz et al., 2001), which will be supplemented with chart review.	From enrollment to 3-month follow-up at 24 weeks
Non-Suicidal Self-Injury	Measured using an adapted version of the Self-Injurious Thoughts and Behaviors Interview (SITBI)-Short Form, Thoughts of NSSI and NSSI subscales (Nock et al., 2007), which assesses history and characteristics of NSSI thoughts and behaviors. First instance of engagement in NSSI after beginning treatment will be the outcome of most interest, but other outcomes assessed by the interview (e.g., frequency of NSSI thoughts) may be examined as well if rates of NSSI are very low.	From enrollment to 3-month follow-up at 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Symptoms	We will measure anxiety using the Revised Child Anxiety and Depression Scale (RCADS)-Short Version (Ebesutani et al., 2012; 2017), which is a 25-item measure of depression and anxiety symptoms that includes both parent-and self-report measures. Both versions are rated on a 5-point Likert scale, with higher scores indicating greater frequency of anxiety symptoms. Anxiety items are summed to yield a raw score, which is then converted to a t-score. The measure has good psychometric properties and treatment sensitivity (Ebesutani et al., 2012; 2017).	From enrollment to 3-month follow-up at 24 weeks
Depression Symptoms	We will measure depression using the Revised Child Anxiety and Depression Scale (RCADS)-Short Version (Ebesutani et al., 2012; 2017), which is a 25-item measure of depression and anxiety symptoms that includes both parent-and self-report measures. Both versions are rated on a 5-point Likert scale, with higher scores indicating greater frequency of depression symptoms. Depression items are summed to yield a total raw score, which is then converted to a t-score. The measure has good psychometric properties and treatment sensitivity (Ebesutani et al., 2012; 2017).	From enrollment to 3-month follow-up at 24 weeks
Disruptive Behavior Symptoms	We will measure disruptive behaviors using the Disruptive Behavior Disorders Scale (DBRS)-Parent Version (Fosco et al., 2023), a 45-item rating scale used to assess symptoms of inattention, hyperactivity-impulsivity, and oppositional defiant behavior among school-aged children. Items are rated on a 4-point scale, with higher scores indicating greater severity of symptoms.	From enrollment to 3-month follow-up at 24 weeks
Emotion Dysregulation--Reactivity	Measured using the Emotion Dysregulation Inventory-Reactivity Short Form (EDI-R; Mazefsky et al., 2018; 2021), which includes a 7-item, caregiver report measure of emotional reactivity. Items are rated on a 5-point Likert scale, with higher scores indicating greater emotional reactivity.	From enrollment to 3-month follow-up at 24 weeks
Emotion Dysregulation--Dysphoria	Measured using the Emotion Dysregulation Inventory-Dysphoria Short Form (EDI-D; Mazefsky et al., 2018; 2021), which is a 6-item, caregiver report measure of dysphoria in youth. Items are rated on a 5-point Likert scale, with higher scores indicating greater dysphoria.	From enrollment to 3-month follow-up at 24 weeks
Caregiver Report of Preadolescent Executive Functioning	The Brief Rating Inventory of Executive Function 2nd Edition (BRIEF 2) --Parent Form (Gioia et al., 2015) is 63-item questionnaire with eight clinical scales designed to assess everyday behaviors associated with seven domains of EF. These scales are combined to form two broader indices (Behavioral Regulation and Metacognition) and a Global Executive Composite score. Items are rated on a 4-point scale, and sum scores for each scale and index are converted to t-scores, with higher t-scores indicating greater difficulties with executive functioning. The measure has strong psychometric properties, discriminates between typically developing and clinical populations, and is sensitive to change.	From enrollment to 3-month follow-up at 24 weeks
Behavioral Assessment of Executive Functioning and Distress Tolerance	Executive Function Challenge Task (EFCT; Kenworthy et al., 2014, 2020) is a "hot" measure of EF that uses a standardized protocol to assess flexibility and planning during several activities with an examiner that change rules or modalities. The EFCT has precise behavioral markers to guide scoring on a three-point scale and yields flexibility and planning raw scores that range from 0 to 8. The EFCT has good psychometric properties and demonstrated moderate associations with parent-reported EF and treatment-specific sensitivity to change (Kenworth et al., 2014; 2020).	From enrollment through post-treatment at 12 weeks
Task-Based Assessment of Executive Functioning	NIH toolbox Dimensional Change Card Sort test (DCCS; Kavanaugh et al., 2020; Zelazo et al., 2013). is a standard, lab-based, computerized task for assessing cognitive flexibility, will be administered as a computerized measure of EF. The DCCS has been validated in youth, does not demonstrate practice effects, and has excellent convergent validity.	From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Feasibility; Randomized controlled trial; Children; Self-Injury; Preadolescents; Suicidal ideation and behavior
• Additional Relevant MeSH Terms: Behavioral Symptoms; Suicide; Social Behavior; Self-Control; Suicidal Ideation; Self-Injurious Behavior; Behavior; Emotional Regulation; Therapeutics
• Other Study ID Numbers: 24-1783; R34MH135963 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD from the randomized controlled trial will be shared with the NIMH National Data Archive.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No