Developing a Digital Intervention for Adolescent Nonsuicidal Self-injury

Not Applicable

Not yet recruiting

• Conditions: Nonsuicidal Self-injury; Depression; Anxiety

• Registration Number: NCT07224165
• Lead Sponsor: Northwestern University

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.

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 Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-31
• Study First Submitted QC: 2025-10-31
• Study First Posted: 2025-11-04
• Last Update Submitted: 2025-11-04
• Last Update Posted: 2025-11-06
• Study Start: 2026-01-01
• Primary Completion: 2027-02-28
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Actual help-seeking questionnaire (AHSQ)	16 weeks	10-item measure assessing recent help-seeking from a variety of formal and informal sources
Alexian Brothers Assessment of Self-Injury - Methods checklist	16 weeks	16-item checklist that assesses the frequency (days/times) of common NSSI methods within the past month.
Acceptability of Intervention Measure (AIM)	8 weeks	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.
Intervention Appropriateness Measure (IAM)	8 weeks	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.