Psychological Treatment for Adolescents With Self-injury Within Intensive Mental Health Outpatient Services: Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Degree of participation in data collection
研究概览
简要总结
The overarching aim of this study is to develop and evaluate a new blended treatment format, which combines face-to-face and digital treatment components, for Emotion Regulation Individual Therapy for Adolescents (ERITA). This brief, transdiagnostic, and blended treatment targeting nonsuicidal self-injury (NSSI) - referred to as blended ERITA - will be specifically designed for adolescents with NSSI and low levels of functioning within intensive outpatient psychiatric services. The specific purpose of this pilot trial is to investigate feasibility in preparation for a larger trial.
详细描述
NSSI is a growing health crisis among youth and the strongest risk factor for suicide attempts. Scalable and evidence-based treatments are needed but lacking. We have recently shown that a brief digital treatment, Internet-delivered ERITA, can be efficacious compared to treatment as usual only.
However, digital treatment is not suitable for everyone. Adolescents with low levels of functioning have trouble engaging in text-based therapy independently from home. A blended format, which combines in-person and online treatment, may enhance effectiveness; therapists can tailor delivery of material, and adolescents can access the skills when necessary.
This project aims to develop and evaluate a blended version of ERITA - blended ERITA - for adolescents with low levels of functioning. The specific objectives of this pilot study are:
Primary:
- Evaluate the feasibility of the project (i.e., data proportion at the primary endpoint, adherence, treatment completion, and therapist time)
- Evaluate acceptability of blended ERITA (i.e., satisfaction, credibility, negative effects)
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12-17 years old
- •At least one NSSI episode in the past three months
- •A parent willing to engage in the parent program
- •Global functioning corresponding to a rating ≤50 of the Children's Global Assessment Scale (CGAS)
排除标准
- •Immediate suicide risk
- •Social problems needing immediate intervention (e.g., violence within the family)
- •Other psychiatric disorder or symptoms requiring immediate treatment (e.g., severe anorexia nervosa, acute psychosis, severe substance abuse)
- •Ongoing dialectical behavior therapy for adolescents
研究组 & 干预措施
Blended Emotion Regulation Individual Therapy for Adolescents (ERITA)
Participants will receive Blended Emotion Regulation Individual Therapy (ERITA) for 20 weeks. In addition to Blended ERITA, participants are free to will receive any type of concomitant care for 20 weeks as provided by the regular care services.
干预措施: Blended ERITA (Behavioral)
Treatment as usual
Participants will receive treatment as usual for NSSI for 20 weeks. In addition, participants are free to will receive any type of concomitant care for 20 weeks as provided by the regular care services.
干预措施: Concomitant care (Other)
Blended Emotion Regulation Individual Therapy for Adolescents (ERITA)
Participants will receive Blended Emotion Regulation Individual Therapy (ERITA) for 20 weeks. In addition to Blended ERITA, participants are free to will receive any type of concomitant care for 20 weeks as provided by the regular care services.
干预措施: Concomitant care (Other)
Treatment as usual
Participants will receive treatment as usual for NSSI for 20 weeks. In addition, participants are free to will receive any type of concomitant care for 20 weeks as provided by the regular care services.
干预措施: Treatment as Usual (TAU) (Behavioral)
结局指标
主要结局
Degree of participation in data collection
时间窗: One-month post-treatment
Proportion of adolescents completing the primary clinical outcome, Deliberate Self-harm Inventory - Youth version, either through interview or self-report questionnaire at one-month post-treatment.
Treatment completion
时间窗: Post-treatment (week 20)
Proportion of adolescents completing ≥ six ERITA modules. Only in the experimental condition. Clinician-rated
Therapist time
时间窗: Post-treatment (week 20)
Therapists will report time for having sessions with adolescents and/or parents or giving feedback on the digital platform. Only in the experimental condition.
Credibility/Expectancy Questionnaire (CEQ)
时间窗: Week 2 (after first week in treatment)
CEQ measures treatment credibility and expectancy. Scale points range from 0-9, and 0-100%, where higher scores indicate greater credibility and expectancy. Self-rated by adolescents. Only in the experimental condition.
Emotion regulation therapy adherence checklist
时间窗: Through study completion, an average of 1 year
This checklist measures therapist adherence to emotion regulation therapy. Adapted to be suitable for therapy with adolescents. Only in the experimental condition.
Client Satisfaction Questionnarie (CSQ)
时间窗: Post-treatment (week 20)
The CSQ measures satisfaction with treatment. This scale has 8 items and a summary score ranging from 8 to 32, with higher scores indicating greater treatment satisfaction. Self-reported (adolescents and parents).
Adverse events
时间窗: Post-treatment and through study completion, an average of 1 year
A scale where participants are asked to report, describe, and rate the discomfort/impact of any negative effects or adverse events caused by their participation in the treatment. Participants rate the impact of potential adverse events when it happened and today on a scale from 1 to 4, where a higher score indicates greater impact. Self-reported (adolescents and parents). Adverse events will be recorded by PI throughout the treatment period.
次要结局
- Deliberate Self-harm Inventory - Youth version (DSHI-Y)(One- and three-months post-treatment)
- Deliberate Self-harm Inventory - Youth version (DSHI-Y)(Baseline, one-, and three-months post-treatment)
- Difficulties in Emotion Regulation Scale - 16 items version (DERS-16)(Baseline, one-, and three-months post-treatment)
- Clinical Global Assessment Scale (CGAS)(Baseline, one-, and three-months post-treatment)
- Borderline Symptom List - Behavior Supplement (BSL-Supplement)(Baseline, one-, and three-months post-treatment)
- Child Health Utility 9D Index (CHU-9D)(Baseline, one-, and three-months post-treatment)
- Revised Child Anxiety and Depression Scale-Short Version (RCADS-25)(Baseline, one-, and three-months post-treatment)
- Coping with Children's Negative Emotions Scale - Adolescent version (CCNES-A)(Baseline, one-, and three-months post-treatment)
- The Work and Social Adjustment Scale -Youth version (WSAS-Y)(Baseline, one-, and three-months post-treatment)
- The Work and Social Adjustment Scale - Parent version (WSAS-P)(Baseline, one-, and three-months post-treatment)
研究者
Olivia Ojala
Principal Investigator
Karolinska Institutet