Developing a Digital Intervention for Adolescent Nonsuicidal Self-injury

Last updated: June 8, 2026
Sponsor: Northwestern University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Panic Disorders

Anxiety Disorders

Depression

Treatment

App-based digital mental health intervention for adolescent NSSI

App-based delivery of healthy living psychoeducational materials

Clinical Study ID

NCT07224165
STU00219136
K01MH131898
  • Ages 14-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Current NSSI (NSSI on 2 or more days in the last month

  • English language skills sufficient to engage in the consent and interventionprocedures

  • Age 14-18

  • Access to smartphone

Exclusion

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 Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: App-based digital mental health intervention for adolescent NSSI
Phase:
Study Start date:
June 04, 2026
Estimated Completion Date:
July 31, 2027

Study 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.

Connect with a study center

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.