Developing a Digital Intervention for Adolescent Nonsuicidal Self-injury

NCT07224165 | Not Yet Recruiting DMC

• 2 other identifiers: STU00219136K01MH131898
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Nonsuicidal Self-injury; Depression; Anxiety

Outcome Measures

Primary Outcomes (4)

• Actual help-seeking questionnaire (AHSQ)

  10-item measure assessing recent help-seeking from a variety of formal and informal sources

  16 weeks

• 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

• 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

Study Arms (2)

Self-guided digital intervention for NSSI

EXPERIMENTAL

This is the experimental condition

Device: App-based digital mental health intervention for adolescent NSSI

Self-guided delivery of healthy living psychoeducational materials

ACTIVE COMPARATOR

This is the comparison condition

Device: App-based delivery of healthy living psychoeducational materials

Interventions

App-based digital mental health intervention for adolescent NSSI DEVICE

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.

Self-guided digital intervention for NSSI

App-based delivery of healthy living psychoeducational materials DEVICE

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.

Self-guided delivery of healthy living psychoeducational materials

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• Northwestern University: lead

MeSH Terms

Conditions

Self-Injurious Behavior; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Kaylee Kruzan, PhD, LCSW

CONTACT

312-503-3114; kaylee.kruzan@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: October 31, 2025
• First Posted: November 4, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after publication of the primary outcome papers.
• Access Criteria: The NIMH Data Archive is managed by the NIMH. Access criteria are determined by the NIMH.