Developing a Digital Intervention for Adolescent Nonsuicidal Self-injury
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
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
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
Kaylee Kruzan
Research Assistant Professor
Northwestern University
