Internet-delivered Emotion Regulation Individual Therapy or Adolescents (IERITA) With Self-injury Within Child and Adolescent Mental Health Services: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Adapted ICBT Therapist Rating Scale (ICBT-TRS)
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 to optimize treatment outcomes for those adolescents at risk of insufficient effects. The specific purpose of this pilot trial is to investigate feasibility in preparation for a larger trial.
详细描述
Self-injury without the intention to die 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 self-injury entails risks and suffering.
In this randomized controlled pilot 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, non-remission will be predicted. Adolescents allocated to adaptable IERITA and classified as likely non-remission, will change to adapted IERITA for the remaining eight weeks while all other participants will continue standard IERITA. Data will be collected pre-treatment, during treatment, post-treatment, one- three- and twelve-month post-treatment. The primary endpoint is one-month post-treatment.
The main objective is to investigate the project's feasibility and test key components. The specific objectives are:
- Examine the feasibility of the project (treatment satisfaction and adherence, degree of participation in data collection, and level of resources).
- Explore the utility of adapted IERITA compared to standard IERITA for adolescents at risk of non-remission.
- Evaluate the performance of the algorithm predicting treatment non-remission.
This project is sponsored by the Swedish Research Council for Health, Working life, and Welfare (number 2024-01916)
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
Participants and outcome assessors will be masked to allocation and classification. Therapists will be masked until treatment week four.
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
研究组 & 干预措施
Adaptable Internet-delivered emotion regulation individual therapy adjunctive to treatment as usual
Participants will receive Internet-delivered Emotion Regulation Individual Therapy (IERITA) for 12 weeks. Adolescents allocated to experimental arm and classified as likely non-remission, will change to adapted IERITA in treatment week four. Adolescents allocated to experimental arm and classified as likely remission will continue standard IERITA. In addition to IERITA, participants are free to will receive any type of treatment as usual for 12 weeks as provided in the community.
干预措施: Treatment as usual (Other)
Adaptable Internet-delivered emotion regulation individual therapy adjunctive to treatment as usual
Participants will receive Internet-delivered Emotion Regulation Individual Therapy (IERITA) for 12 weeks. Adolescents allocated to experimental arm and classified as likely non-remission, will change to adapted IERITA in treatment week four. Adolescents allocated to experimental arm and classified as likely remission will continue standard IERITA. In addition to IERITA, participants are free to will receive any type of treatment as usual for 12 weeks as provided in the community.
干预措施: Adaptable IERITA (Behavioral)
Standard Internet-delivered emotion regulation individual therapy adjunctive to treatment as usual
Participants will receive Internet-delivered Emotion Regulation Individual Therapy (IERITA) for 12 weeks. All participants will continue standard IERITA throughout the treatment period. In addition to IERITA, participants are free to will receive any type of treatment as usual for 12 weeks as provided in the community.
干预措施: Standard IERITA (Behavioral)
Standard Internet-delivered emotion regulation individual therapy adjunctive to treatment as usual
Participants will receive Internet-delivered Emotion Regulation Individual Therapy (IERITA) for 12 weeks. All participants will continue standard IERITA throughout the treatment period. In addition to IERITA, participants are free to will receive any type of treatment as usual for 12 weeks as provided in the community.
干预措施: Treatment as usual (Other)
结局指标
主要结局
Adapted ICBT Therapist Rating Scale (ICBT-TRS)
时间窗: Through study completion, an average of 1 year
Therapist behaviors are rated separately as 0 (absence of behavior), 1 (inadequate performance), or 2 (competent). Rated by experienced clinical supervisors.
Deliberate Self-harm Inventory - Youth version (DSHI-Y)
时间窗: One-, three- and twelve-months post-treatment
The DSHI-Y measures the frequency of the most common NSSI behaviors. The primary outcome will be the proportion of treatment remission. Remission will be defined as the absence of self-injury the past 30 days. Clinician-rated.
Internet Intervention Patient Adherence Scale (iiPAS)
时间窗: Treatment week 3 and post-treatment (week 12)
The IIPAS measures patient adherence to guided internet-delivered behavioral interventions. This scale has 5 items, and a total score ranging from 0 to 20, where 0 indicates no adherence and 20 perfect adherence. Clinician-rated.
Credibility/Expectancy Questionnaire (CEQ) - 1 item version
时间窗: Treatment week 3
CEQ measures treatment credibility and expectancy. This version of the scale has 1 item ranging from 0 to 100, with higher scores indicating greater credibility/expectancy. Self-rated (adolescent).
The Client Satisfaction Questionnaire (CSQ)
时间窗: Post-treatment (week 12)
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-rated (adolescent and parent).
Therapist time
时间窗: Post-treatment (week 12)
Clinicians report time spent on treatment.
Number of completed sessions and modules
时间窗: Post-treatment (week 12)
Clinicians report number of completed sessions and modules for adolescents and parents.
Rate of treatment adaptions
时间窗: Post-treatment (week 12)
Clinicians report presence or absence of possible treatment adaptions (e.g., changes in therapist contact or what material to focus on).
Degree of partcipation in data collection
时间窗: One-month post-treatment
The 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
Deliberate Self-harm Inventory - Youth version (DSHI-Y)
时间窗: One-, three- and twelve-months post-treatment
The DSHI-Y measures the frequency of the most common NSSI behaviors. The primary outcome will be the proportion of treatment remission. Remission will be defined as the absence of self-injury the past 30 days. Clinician-rated.
Internet Intervention Patient Adherence Scale (iiPAS)
时间窗: Treatment week 3 and post-treatment (week 12)
The IIPAS measures patient adherence to guided internet-delivered behavioral interventions. This scale has 5 items, and a total score ranging from 0 to 20, where 0 indicates no adherence and 20 perfect adherence. Clinician-rated.
Credibility/Expectancy Questionnaire (CEQ) - 1 item version
时间窗: Treatment week 3
CEQ measures treatment credibility and expectancy. This version of the scale has 1 item ranging from 0 to 100, with higher scores indicating greater credibility/expectancy. Self-rated (adolescent).
The Client Satisfaction Questionnaire (CSQ)
时间窗: Post-treatment (week 12)
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-rated (adolescent and parent).
Therapist time
时间窗: Post-treatment (week 12)
Clinicians report time spent on treatment.
Number of completed sessions and modules
时间窗: Post-treatment (week 12)
Clinicians report number of completed sessions and modules for adolescents and parents.
Rate of treatment adaptions
时间窗: Post-treatment (week 12)
Clinicians report presence or absence of possible treatment adaptions (e.g., changes in therapist contact or what material to focus on).
Degree of partcipation in data collection
时间窗: One-month post-treatment
The 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
Adapted ICBT Therapist Rating Scale (ICBT-TRS)
时间窗: Through study completion, an average of 1 year
Therapist behaviors are rated separately as 0 (absence of behavior), 1 (inadequate performance), or 2 (competent). Rated by experienced clinical supervisors.
次要结局
- Deliberate Self-harm Inventory - Youth version (DSHI-Y)(Baseline, one-, three- and twelve-months post-treatment)
- Children's Global Assessment Scale (CGAS)(Baseline, one-, three- and twelve-months post-treatment)
- The Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A)(Baseline, one-, three- and twelve-months post-treatment)
- Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)(Baseline, one-, three- and twelve-months post-treatment)
- Child Health Utility 9D (CHU-9D)(Baseline, one-, three- and twelve-months post-treatment)
- Borderline symtom checklist supplement (BSL)(Baseline, one-, three- and twelve-months post-treatment)
- The Revised Child Anxiety and Depression Scale-Short Version (RCADS-25)(Baseline, one-, three- and twelve-months post-treatment)
- The Work and Social Adjustment Scale -Youth version (WSAS-Y)(Baseline, one-, three- and twelve-months post-treatment)
- The Work and Social Adjustment Scale - Parent version (WSAS-P)(Baseline, one-, three- and twelve-months post-treatment)
- Deliberate Self-harm Inventory - Youth version (DSHI-Y)(Baseline, one-, three- and twelve-months post-treatment)
- The Revised Child Anxiety and Depression Scale-Short Version (RCADS-25)(Baseline, one-, three- and twelve-months post-treatment)
- Borderline symtom checklist supplement (BSL)(Baseline, one-, three- and twelve-months post-treatment)
- Child Health Utility 9D (CHU-9D)(Baseline, one-, three- and twelve-months post-treatment)
- Children's Global Assessment Scale (CGAS)(Baseline, one-, three- and twelve-months post-treatment)
- Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)(Baseline, one-, three- and twelve-months post-treatment)
- The Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A)(Baseline, one-, three- and twelve-months post-treatment)
- The Work and Social Adjustment Scale -Youth version (WSAS-Y)(Baseline, one-, three- and twelve-months post-treatment)
- The Work and Social Adjustment Scale - Parent version (WSAS-P)(Baseline, one-, three- and twelve-months post-treatment)
研究者
Olivia Ojala
Principal Investigator
Karolinska Institutet