跳至主要内容
临床试验/NCT07224165
NCT07224165招募中不适用

Developing a Digital Intervention for Adolescent Nonsuicidal Self-injury

Northwestern University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年6月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Actual help-seeking questionnaire (AHSQ)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Self-guided digital intervention for NSSI

Experimental

This is the experimental condition

干预措施: App-based digital mental health intervention for adolescent NSSI (Device)

Self-guided delivery of healthy living psychoeducational materials

Active Comparator

This is the comparison condition

干预措施: App-based delivery of healthy living psychoeducational materials (Device)

结局指标

主要结局

Actual help-seeking questionnaire (AHSQ)

时间窗: 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

时间窗: 16 weeks

16-item checklist that assesses the frequency (days/times) of common NSSI methods within the past month.

Acceptability of Intervention Measure (AIM)

时间窗: 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)

时间窗: 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.

Actual help-seeking questionnaire (AHSQ)

时间窗: 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

时间窗: 16 weeks

16-item checklist that assesses the frequency (days/times) of common NSSI methods within the past month.

Acceptability of Intervention Measure (AIM)

时间窗: 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)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kaylee Kruzan

Research Assistant Professor

Northwestern University

研究点 (1)

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