Developing a Digital Intervention for Adolescent Nonsuicidal Self-injury

This is a feasibility trial of a digital mental health intervention aimed at adolescents (ages 14-18) with nonsuicidal self-injury and who are not currently engaged in mental health treatment. The study has two arms: a self-guided DMHI and an active control which will involve the delivery of non-interactive psychoeducational content via the same app interface. The primary goals of this project are to evaluate the feasibility of the intervention and trial procedures in preparation for a fully-powered randomized-controlled trial.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Anxiety; Nonsuicidal Self-injury
• Intervention / Treatment: Device: App-based digital mental health intervention for adolescent NSSI; Device: App-based delivery of healthy living psychoeducational materials

Detailed Description

The primary purpose of this trial is to test the feasibility of conducting a randomized controlled trial (RCT) of an 8-week digital mental health intervention (DMHI) for non-treatment engaged adolescents who engage in nonsuicidal self-injury. The DMHI will include a highly interactive conversational agent that conveys psychoeducational content and guides participants through skill-based activities. The study team will conduct a 2-arm feasibility trial, randomizing participants to receive either DMHI (weeks 1-8) or an active psychoeducational control (weeks 1-8). Participants will be 1:1 randomized to arms in varying block sizes of 4 and 6. To prevent allocation bias, randomization will be conducted by the biostatistician, who will not inform the study team of the treatment arms until the baseline assessment has been completed and the participant has been enrolled.

The primary clinical outcome measures will be frequency and severity of NSSI behavior (ABASI) and help-seeking activities (AHSQ). Implementation potential outcomes include intervention acceptability (IAM) and appropriateness (AIM).

This study will enroll individuals who have meet the following eligibility criteria: 1) Current NSSI, defined as NSSI on 2 or more days in the past month, as assessed by the Alexian Brothers Assessment of Self-Injury (ABASI). 2) English language skills sufficient to engage in the consent and intervention procedures. 3) Age 14 to 18. 4) Access to smartphone.

Exclusion criteria include: 1) Severe mental health diagnoses for which this intervention would be inappropriate (e.g., psychotic disorders, active manic episodes), 2) Severe suicide risk, including suicidal ideation with a plan and intent to act or history of suicide attempt in the past 3 months; or 3) Current engagement in psychotherapy (at baseline and for the trial recruitment only). Participants will be permitted to seek treatment at any point once enrolled in the study.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kaylee Kruzan, PhD, LCSW; Phone Number: 312-503-3114; Email: kaylee.kruzan@northwestern.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Current NSSI (NSSI on 2 or more days in the last month
• English language skills sufficient to engage in the consent and intervention procedures
• Age 14-18
• Access to smartphone

Exclusion Criteria:

• Severe mental health diagnoses for which this intervention would be inappropriate (psychotic disorders, active manic episodes)
• Severe suicide risk, including suicidal ideation with a plan and intent to act
• Current engagement in psychotherapy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-guided digital intervention for NSSI; This is the experimental condition	Device: App-based digital mental health intervention for adolescent NSSI; The digital intervention for NSSI is an app-based intervention consisting of 16 modules (8 focused on internal skills and 8 focused on external sources of support) to be delivered twice weekly for 8 weeks. Modules containing psychoeducation and skill-based practice, and brief assessments. All content is delivered by a highly interactive conversational agent that guides users through the app content via a text-like interface. Psychoeducational content and strategies center on cognitive behavioral principles and support increased knowledge of external sources of support. Brief assessments examine NSSI and use of skills.
Active Comparator: Self-guided delivery of healthy living psychoeducational materials; This is the comparison condition	Device: App-based delivery of healthy living psychoeducational materials; The control intervention is an app-based adolescent healthy living intervention consisting of 16 modules containing psychoeducation (e.g., sleep hygiene, water intake, exercise). Modifications will be made to an existing intervention used as a control in prior studies, 1,2 to mitigate potential contraindication for participants with eating disorder comorbidity by replacing nutrition with sun exposure content and an expansion of module content on sleep hygiene and exercise. Like the treatment app, all content in the control app is delivered by a highly interactive conversational agent that guides users through the app content via a text-like interface. Psychoeducational content and psychological strategies delivered center on stress management and healthy living.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alexian Brothers Assessment of Self-Injury - Methods checklist	16-item checklist that assesses the frequency (days/times) of common NSSI methods within the past month.	16 weeks
Actual help-seeking questionnaire (AHSQ)	10-item measure assessing recent help-seeking from a variety of formal and informal sources	16 weeks
Acceptability of Intervention Measure (AIM)	4-item measure of intervention acceptability. Item responses are measured on a Likert scale from 1-5. So total scores can vary from 4-20 with 20 representing more acceptability.	8 weeks
Intervention Appropriateness Measure (IAM)	4-item measure of intervention appropriateness. Item responses are measured on a Likert scale from 1-5. So total scores can vary from 4-20 with 20 representing more appropriateness.	8 weeks

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: October 31, 2025
• First Submitted That Met QC Criteria: October 31, 2025
• First Posted (Actual): November 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression; Self-Injurious Behavior
• Other Study ID Numbers: STU00219136; K01MH131898 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be shared through and managed by the NIMH Data Archive (NDA). De-identified human subjects data, harmonized to a common standard, are available to qualified researchers.
• IPD Sharing Time Frame: Data will be available after publication of the primary outcome papers.
• IPD Sharing Access Criteria: The NIMH Data Archive is managed by the NIMH. Access criteria are determined by the NIMH.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No