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Group Treatment for Self-harming Adolescents and Their Parents: a Randomized Controlled Trial (ERA)

2026年8月17日 更新者：Hanna Sahlin、Karolinska Institutet

A Randomised Controlled Trial of Group Emotion Regulation for Adolescent Self-harm (the ERA-study)

Adolescent non-suicidal self-injury (NSSI) is common, strongly associated with psychiatric comorbidity and an increased risk of future suicide attempt. Although interventions targeting emotion regulation have been shown to reduce NSSI in both adults and adolescents few, are available within routine child and adolescent mental health services (CAMHS). Emotion Regulation for Adolescents (ERA), adapted from an evidence-based adult intervention is a brief group-based treatment designed to increase access to effective, evidence-based care for adolescents with NSSI. A large-scale randomised controlled trial (RCT) is needed to establish its efficacy and strengthen the evidence base for emotion regulation interventions for adolescent NSSI.

The overall aim of this project is to increase the availability of evidence-based psychological treatments for adolescent NSSI by developing and evaluating Emotion Regulation for Adolescents (ERA), a novel behavioural and acceptance-based intervention. The main objectives are to establish the efficacy, cost-effectiveness, and long-term outcomes of ERA for adolesent NSSI in two arm RCT comparing ERA with an active control condition (FUNK) as well as to investigate potential mediators such as emotion regulation and self-criticism.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

Primary and secondary objectives

Primary objective:

To determine the clinical efficacy of Emotion Regulation group therapy for Adolescents (ERA) in reducing NSSI frequency, as assessed by the clinician-rated Deliberate Self-Harm Inventory, Youth Version (DSHI-Y) in adolescents with NSSI, compared to an active control condition (FUNK). The primary endpoint is 1-month post-treatment.

Secondary objectives:

  1. To determine the efficacy of ERA compared to an active control condition (FUNK) in reducing NSSI severity, increasing NSSI abstinence, reducing impulsive and destructive behaviours, emotion dysregulation and self-criticism anxiety and depressive symptoms; and improving general functioning at 1-month post-treatment.
  2. To evaluate the durability of the treatment effects at 12-month follow-up
  3. To investigate whether improvements in emotion regulation and reductions in self-criticism mediate reductions in NSSI at the primary endpoint (1-month post-treatment).
  4. To conduct a health-economic evaluation of ERA compared with FUNK at 12-month follow-up from the perspectives of the healthcare payer; healthcare system resource use, and society.

Research questions:

  1. Is ERA more efficacious than FUNK in reducing NSSI frequency?
  2. Is ERA more efficacious than FUNK in reducing NSSI severity, increasing NSSI abstinence, reducing impulsive destructive behaviours, emotion dysregulation and self-criticism, anxiety and depressive symptoms; and improving global functioning?
  3. Are the treatment effects of ERA maintained at 12-month follow-up?
  4. Do improvements in emotion regulation and reductions in self-criticism mediate effects on NSSI?
  5. Is ERA more cost-effective than FUNK from healthcare and societal perspectives?

研究の種類

介入

入学 (推定)

180

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Hanna Sahlin, PhD, Ass Prof
  • 電話番号：+46706005920
  • メール：Hanna.Sahlin@ki.se

研究連絡先のバックアップ

  • 名前：Ann Rosén, PhD
  • 電話番号：+46733500371
  • メール：Ann.Rosen@ki.se

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Age: 13 - 17 years
  • At least 5 instances of NSSI in the past year, and at least one during the past month
  • ≥5 episodes of NSSI in the past year, including ≥1 in the past month
  • If receiving antidepressant, central stimulants or neuroleptic medication, dose must be stable for least 6 weeks prior to inclusion
  • At least one participating caregiver
  • Sufficient Swedish language proficiency (adolescent and caregiver)
  • Regular access to a smartphone for SMS-based assessment

Exclusion Criteria:

  • Intellectual disability or a severe psychiatric disorder requiring immediate treatment (e.g., psychosis, bipolar disorder type 1, anorexia nervosa, alcohol/substance dependence) or conditions that prevent participation (e.g., severe social anxiety, selective mutism)
  • Acute suicide risk (i.e., current suicide plans) or recent suicide attempt
  • Previous or ongoing structured emotion regulation treatment involving at least 3 sessions during the past 12 months
  • Previous or ongoing structured emotion regulation treatment (≥3 sessions within past 12 months)
  • Social circumstances preventing participation or require immediate action (e.g., domestic violence, abuse and/or neglect in the family, inpatient care)
  • Ongoing structured psychological treatment targeting NSSI

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：Emotion Regulation Adolescents (ERA).
Manualized 12-week group intervention for adolescents with NSSI and a parallel five-session parent program.
行動：Emotion Regulation Group Therapy for Self-harming Adolescents, ERA

Manualized 12-week group intervention for adolescents with NSSI and a parallel five-session parent program.

Experimental: ERA Participants receive ERA a 12-week manualized group intervention, targeting NSSI. The intervention focuses on increasing adaptive emotion regulation, reducing impulsive behaviours, and increasing acceptance of difficult emotions with integrated exercises to increase self-compassion and reduce self-criticism.

Caregivers participate in a parallel five-session parent group focusing on preventing NSSI contagion, supporting emotion regulation and strengthening adaptive family communication and functioning.
アクティブコンパレータ：Functional habits for mental health (FUNK)
Active comparator: Active Control Condition (FUNK) Manualized psychoeducational group intervention with family participation, individualized safety planning, and weekly risk monitoring.
行動：Functional habits for mental health, FUNK
Active comparator: Active Control Condition (FUNK) Participants receive a manualized active control condition FUNK consisting of: 1) ane individual family session to develop a personalized safety plan; 2) five group-based psychoeducation family sessions over 10 weeks, covering sleep, nutrition and physical activity, anxiety, depression and emotions; and 3) weekly suicide risk monitoring.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change from baseline in clinician-rated scores on Deliberate Self-Harm Inventory - Youth Version (DSHI-Y-7)
時間枠：[Time Frame: Baseline; week 12 post baseline; 1 [PRIMARY ENDPOINT]-, 6- and 12-month follow-up.]
Used to assess frequency, abstinence and severity of non-suicidal self-injury. Clinician-rated. Lower scores means better outcome.
[Time Frame: Baseline; week 12 post baseline; 1 [PRIMARY ENDPOINT]-, 6- and 12-month follow-up.]

二次結果の測定

結果測定
メジャーの説明
時間枠
Clinical Global Impression - Severity (CGI-S)
時間枠：[Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
Used to provide an overall rating of non-suicidal self-injury severity. Clinician-rated. Range: 1-7. Lower scores mean less severe symptoms.
[Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
Clinical Global Impression - Improvement (CGI-I)
時間枠：[Time Frame: Week 12 post baseline; 1-, 6- and 12-month follow-up.]
Used to assess global improvement. Clinician-rated. Range: 1-7. Lower scores mean better outcome.
[Time Frame: Week 12 post baseline; 1-, 6- and 12-month follow-up.]
Children's Global Assessment Scale (CGAS)
時間枠：[Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
Used to assess global psychosocial functioning. Clinician-rated. Range: 1-100. Higher scores means better outcome.
[Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
Deliberate Self-Harm Inventory - Youth Version (DSHI-Y-7)
時間枠：[Time Frame: Baseline; Mid-treatment: once every week (0-12 weeks post baseline); 1-, 6- and 12-month follow-up.]
Used to assess frequency, abstinence and severity of non-suicidal self-injury. Adolescent-rated. Lower scores mean better outcome.
[Time Frame: Baseline; Mid-treatment: once every week (0-12 weeks post baseline); 1-, 6- and 12-month follow-up.]
Borderline Symptom List, supplement (BSL-23, suppl)
時間枠：[Time Frame: Baseline; Mid- treatment: once every week (0-12 weeks post baseline); 1-, 6- and 12-month follow-up.]
Used to assess frequency of impulsive self-destructive behaviors. Adolescent-rated. Lower scores mean better outcome.
[Time Frame: Baseline; Mid- treatment: once every week (0-12 weeks post baseline); 1-, 6- and 12-month follow-up.]
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)
時間枠：[Time Frame: Baseline, Mid-treatment: once every week (0-12 weeks post baseline), 1-,6- and 12- month follow-up.]
Used to assess difficulties in emotion regulation. Adolescent-rated. Parent-rated. Range: 16-80, Higher scores mean greater difficulties.
[Time Frame: Baseline, Mid-treatment: once every week (0-12 weeks post baseline), 1-,6- and 12- month follow-up.]
Everyday Adolescent Emotion Regulation-scale (EARS)
時間枠：[Time Frame: Baseline, Mid-treatment: once every week (0-12 weeks post baseline), 1-,6- and 12- month follow-up.]
Brief measure of emotion regulation developed for this project. Adolescent-rated. Lower scores indicate better outcomes
[Time Frame: Baseline, Mid-treatment: once every week (0-12 weeks post baseline), 1-,6- and 12- month follow-up.]
Self-criticism And Kindness Scale (SAK)
時間枠：[Time Frame: Baseline, week 12 post baseline, 1-,6- and 12- month follow-up.]
Brief measure of self-criticism and self-compassion, developed for this project. Adolescent-rated. Lower scores indicate better outcomes.
[Time Frame: Baseline, week 12 post baseline, 1-,6- and 12- month follow-up.]
Short Revised Children's Anxiety and Depression Scale - Short version (RCADS-S)
時間枠：[Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
Used to assess depression and anxiety symptoms. 25 items. Adolescent- and parent-rated. Range: 0-75, Lower scores mean better outcome.
[Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
The Work and Social Adjustment Scale - Youth Version (WSAS-Y)
時間枠：[Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
Used to assess functional impairment. Adolescent and parent-rated. Range: 0-40. Lower scores means better outcome.
[Time Frame: Baseline; week 12 post baseline; 1-, 6- and 12-month follow-up.]
The Coping with Children's Negative Emotions Scale Adolescent Version (CANES-P).
時間枠：[Time Frame: Baseline; week 12 post baseline, 1-, 6- and 12-month follow-up.]
Used to assess parents' perceived ability to cope with children's negative emotions. Parent-rated. Six subscales: minimization; punitive; emotion-focused coping; problem-focused coping; encourage emotion expression; personal distress. Range: 1-7, higher scores in minimization and punitive subsclaes mean more difficulties. Higher scores in the rest mean better outcome.
[Time Frame: Baseline; week 12 post baseline, 1-, 6- and 12-month follow-up.]
Me as a parent (MaaP)
時間枠：[Time Frame: Baseline; week 12 post baseline, 1-, 6- and 12-month follow-up.]
Questionnaire used to assess parents' beliefs about their locus of control (personal agency) and ability to self-monitor and self-manage. Four subscales: self efficacy; personal agency; self sufficiency; self management. Parent-rated. Range:4-16/ 1-4 (subscales). Higher scores mean better outcome.
[Time Frame: Baseline; week 12 post baseline, 1-, 6- and 12-month follow-up.]
Working Alliance Inventory - Group version (WAI-S)
時間枠：[Time Frame: Mid-treatment (3 weeks post-baseline)]
Used to assess perceived working alliance. Adolesent-rated. Parent-rated. Range: 0-30. Higher scores means better outcome.
[Time Frame: Mid-treatment (3 weeks post-baseline)]
The Client Satisfaction Questionnaire (CSQ-8)
時間枠：[Time Frame: 12 weeks post baseline]
Used to assess client satisfaction with treatment. Adolescent-rated. Parent-rated. Range: 8-32. Higher scores mean better outcome.
[Time Frame: 12 weeks post baseline]
Treatment Credibility and Expectancy Scale (TCES)
時間枠：[Time Frame: Mid-treatment (3 weeks post-baseline)]
Questionnaire revised by the research team. Used to assess treatment credibility and expectations. Adolescent-rated. Parent-rated. Range: 0-40. Higher scores means better outcome
[Time Frame: Mid-treatment (3 weeks post-baseline)]

その他の成果指標

結果測定
メジャーの説明
時間枠
Child Health Utility 9D (CHU9D)
時間枠：[Time Frame: Baseline; 1- and 12-month follow-up.]
Used to assess health-related quality of life for health economic evaluation. Adolescent reported. Higher scores indicate better health-related quality of life.
[Time Frame: Baseline; 1- and 12-month follow-up.]
Trimbos Questionnaire for Costs associated with Psychiatric Illness (TiC-P)
時間枠：[Time Frame: Baseline; 1- and 12-month follow-up.]
Used to assess healthcare and societal resource use Parent reported.
[Time Frame: Baseline; 1- and 12-month follow-up.]
Negative effects questionnaire
時間枠：[Time Frame: Week 6; Week 12 post baseline; 1-, 6- and 12-month follow-up]
Questionnaire developed by the research team. Used to assess adverse events for the adolescent. Adolescent-reported. Parent-reported. Lower scores means better outcome.
[Time Frame: Week 6; Week 12 post baseline; 1-, 6- and 12-month follow-up]

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Karolinska Institutet

協力者

Region Stockholm
Västra Götalandsregionen

捜査官

  • 主任研究者：Hanna Sahlin, PhD, Ass Professor、Karolinska Institutet
  • スタディチェア：Mats J Olsson, Professor、Karolinska Institutet

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月17日

一次修了 (推定)

2032年12月31日

研究の完了 (推定)

2034年12月31日

試験登録日

最初に提出

2026年7月17日

QC基準を満たした最初の提出物

2026年7月17日

最初の投稿 (実際)

2026年7月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月18日

QC基準を満たした最後の更新が送信されました

2026年8月17日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 2025-08964-01
  • 2025-06882 (その他の助成金/資金番号：Swedish Research Council)
  • 2025-00347 (その他の助成金/資金番号：Swedish Research Council for Health, working life and welfare)
  • 2026-03899-02 (その他の識別子：Ethical amendment)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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