Internet-delivered Emotion Regulation Individual Therapy or Adolescents (IERITA) With Self-injury Within Child and Adolescent Mental Health Services
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 341
- 试验地点
- 1
研究概览
简要总结
The overall purpose of the study is to implement and evaluate IERITA (Internet-delivered Emotion Regulation Individual Therapy for Adolescents) within child and adolescent mental health services for adolescents engaging in nonsuicidal self-injury (NSSI) and optimize treatment outcomes for those adolescents at risk of non-remission (continued NSSI).
详细描述
Nonsuicidal self-injury (NSSI) is a growing and urgent global health crisis among youth. It is associated with substantial individual and societal costs, including increased risk of suicide attempts. Scalable and evidence-based treatments are needed but lacking. Digital interventions can be one promising solution. A recent study shows that a novel brief digital treatment, IERITA, can be efficacious compared to treatment as usual only. However, not all respond sufficiently to standardized treatment, such as IERITA, and continued NSSI entails risks and suffering.
In this randomized controlled trial, participants will be randomly allocated (1:1) to standard IERITA or adaptable IERITA. All participants will first receive standard IERITA for four weeks. In treatment week four, or earlier if the adolescent is at risk of discontinuation, classification of non-remission/remission will be conducted. Adolescents allocated to adaptable IERITA and classified as likely non-remission, will change to adapted IERITA (e.g., personalized dose and delivery of treatment) for the remaining weeks (until week 12) while all other participants will continue with standard IERITA. Data will be collected pre-treatment, during treatment, post-treatment, one- three- and twelve-month post-treatment, and in public registers up to ten years post-treatment. The primary endpoint is one-month post-treatment.
The primary aim is to evaluate efficacy of an adaptable treatment strategy for adolescents at risk of non-remission. Secondary aims include implementation, cost-effectiveness, moderators and predictors, distal effects, algorithm performance, and psychometrical evaluations. The specific objectives are:
PRIMARY AIM
- Determine the efficacy of adaptable IERITA compared to standard IERITA for adolescents at risk of non-remission at one-month post-treatment (primary endpoint) and to assess the durability of effects at three-month follow-up
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Therapists will be partially blinded. They will be blinded to treatment allocation and participant classification until treatment week 4, or until a participant is classified as a likely non-remission. At treatment week 4, blinding will be broken only for the subset of participants classified as likely non-remission who are allocated to the adaptable IERITA condition. Therapists will remain blinded to allocation and classification for most participants throughout the trial.
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •13-17 years old
- •At least one self-injury episode in the past three months
- •A parent willing to engage in the parent program
排除标准
- •Immediate suicide risk
- •Global functioning corresponding to a rating ≤40 of the Children's Global Assessment Scale (CGAS)
- •Social problems needing immediate intervention (e.g., violence within the family)
- •Ongoing dialectical behavior therapy for adolescents
研究者
Olivia Ojala
Principal Investigator
Karolinska Institutet