Developing a Digital Intervention for Adolescent Nonsuicidal Self-injury

Northwestern University

Status: Not yet enrolling

Conditions: Nonsuicidal Self-injury; Depression; Anxiety

Treatments: Device: App-based delivery of healthy living psychoeducational materials; Device: App-based digital mental health intervention for adolescent NSSI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07224165

STU00219136

K01MH131898 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 14 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Self-guided digital intervention for NSSI

Experimental group

Description:

This is the experimental condition

Treatment:

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

Self-guided delivery of healthy living psychoeducational materials

Active Comparator group

Description:

This is the comparison condition

Treatment:

Device: App-based delivery of healthy living psychoeducational materials