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Developing a Digital Intervention for Adolescent Nonsuicidal Self-injury

NCT07224165 · Northwestern University
In plain English

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About this study
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.
Eligibility criteria
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
Enrollment target: 80 participants
Allocation: randomized
Masking: triple
Age groups: child, adult
Timeline
Starts: 2026-06-04
Estimated completion: 2027-07-31
Last updated: 2026-07-08
Interventions
Device: App-based digital mental health intervention for adolescent NSSIDevice: App-based delivery of healthy living psychoeducational materials
Primary outcomes
  • Actual help-seeking questionnaire (AHSQ) (16 weeks)
  • Alexian Brothers Assessment of Self-Injury - Methods checklist (16 weeks)
  • Acceptability of Intervention Measure (AIM) (8 weeks)
Sponsor
Northwestern University · other
With: National Institute of Mental Health (NIMH)
Contacts & investigators
ContactKaylee Kruzan, PhD, LCSW · contact · kaylee.kruzan@northwestern.edu · 312-503-3114
All locations (1)
Northwestern UniversityRecruiting
Chicago, Illinois, United States
Developing a Digital Intervention for Adolescent Nonsuicidal Self-injury · TrialPath