Health TrialsbyHealthPanel

Developing a Digital Intervention for Adolescent Nonsuicidal Self-injury

ConditionsNonsuicidal Self-injuryDepressionAnxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-18
SponsorNorthwestern University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Factorial

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Self-guided digital intervention for NSSIExperimental treatment 1 intervention
Group B: Self-guided delivery of healthy living psychoeducational materialsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Actual help-seeking questionnaire (AHSQ)

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

Time frame
16 weeks
2

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.

Time frame
16 weeks
3

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.

Time frame
8 weeks
4

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.

Time frame
8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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