跳至主要内容
临床试验/NCT07021274
NCT07021274招募中不适用

DBT Skill Training for Autistic Adults With Difficulties in Emotion Regulation: a Feasibility Study.

Helse Møre og Romsdal HF1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
1
主要终点
Difficulties in emotion regulation scale (DERS) - 8

研究概览

简要总结

One in 44 has autism, 70% of them have additional mental health challenges. Currently, this patient population does not have access to effective treatment within specialist healthcare services and has struggled to benefit from standard treatments. The goal of this project is to increase access to treatment tailored to their challenges. We will investigate whether a treatment program with an adapted version of Dialectical Behavior Therapy (DBT) is feasible, accepted, and perceived as useful for people with autism. The purpose of the treatment is to improve emotion regulation, function better in relationships, and avoid crises, thereby enhancing their ability to achieve personal goals, reduce suffering, and increase quality of life. Autism is a lifelong neurodevelopmental disorder, presenting with great variation and more widespread than previously thought. Difficulties with emotion regulation are a central challenge for many with autism. These difficulties often manifest as an inability to recognize, understand, and manage emotional responses, leading to destructive strategies, behaviors, and suffering. DBT is developed with a focus on emotion regulation and has shown good effects in other patient populations. The project can increase access to treatment for a patient population that currently stands without.

详细描述

Autism Spectrum Disorder (ASD) is a lifelong neurodevelopmental condition marked by difficulties in social interaction, communication, sensory sensitivities, and repetitive behaviors. ASD varies widely among individuals and has become more recognized over time. The prevalence of ASD has significantly increased, with the U.S Centers for Disease Control and Prevention (CDC) reporting a rise from 1 in 2,222 children in 1968 to 1 in 44 children in 2020. This increase is due to evolving definitions, greater awareness, and differences in study methodologies.

Many individuals with ASD, especially those without intellectual disabilities, often remain undiagnosed until adulthood. Undiagnosed ASD is common in adult clinical populations, with a Swedish study finding that 18.9% of psychiatric outpatients had ASD. Psychiatric comorbidities are frequent in ASD, including anxiety, depression, attention deficit hyperactity disorder (ADHD), obsessive compulsive disorder (OCD), bipolar disorders, and sleep-wake disorders, complicating diagnosis and treatment. Autistic individuals often engage in suicidal behaviors, self-harm, and aggression, impacting daily life.

Autistic women without intellectual disabilities are often underdiagnosed due to less overt symptoms and their ability to camouflage difficulties. Misdiagnosis with personality disorders, particularly borderline personality disorder, is common.

Despite rising diagnosis rates, there is a lack of evidence-based treatment options for autistic adults, especially for those with comorbid mental disorders. Many clinicians lack training to work with autistic adults, and ASD specialists often lack expertise in treating co-occurring conditions. In Norway, there is a significant gap in treatment options for autistic adults without intellectual disabilities.

Emotion regulation difficulties are central challenges for many autistic adults, involving physiological arousal, brain region alterations, and unique ASD mechanisms like cognitive rigidity. Autistic adults often struggle with alexithymia, exacerbating emotion regulation issues. Developing effective emotion regulation strategies can improve quality of life.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fit general inclusion criteria for the out- patient treatment at the clinic.
  • Have diagnosed autism, and pervasive difficulties in emotion regulation.
  • Speak Scandinavian (Norwegian, Danish and/or Swedish).
  • Manage to commit to participating in the DBT- skills training.
  • Be willing to sign the written informed consent.

排除标准

  • Have a clinically significant low linguistic functioning that hinders the patient in understanding and answering the questions on the self-report instruments.
  • Being actively psychotic.
  • Have a Body Mass Index (BMI) under
  • Cognitive disability Intelliganve quotient (IQ) <85

研究组 & 干预措施

Participate in DBT skills training

Experimental

The intervention period will be from August 2025- February 2027.

DBT- skills is a group skills training component of Dialectical Behaviour therapy a comprehensive treatment focused on extensive difficulties in emotion regulation. In this project, the investigators will use the standard DBT skill-training model with an addition of Autism specific interventions and adjustments.

The DBT-SUD Skills intervention consists of:

2-3 sessions with a DBT therapist focusing on treatment orientation - mapping the patients' goals, obstacles, and resources, DBT- hierarchy, and commitment.

Skills training - 28, two-hour sessions - once a week.

1 status and evaluation session half-way through the skills training.

1 summary session with a focus on goals reached and troubleshooting.

Two DBT therapists lead the group, and each group consists of approx. 4-6 participants.

干预措施: DBT skills training adjusted to autistic needs (Behavioral)

结局指标

主要结局

Difficulties in emotion regulation scale (DERS) - 8

时间窗: From enrollment to the end of treatment at 28 weeks.

a shortened self-report instrument, developed from the original DERS-36 meant to measure difficulties in emotion regulation. The DERS-8 consists of 8 items prefaced with the phrase "When I'm upset," to provide respondents with a uniform context that elicits thinking about situations requiring regulation of negative emotion; answers to items likely to represent affect, thought, and actions in response to such situations. The scale offers a brief unidimensional measure of difficulties in emotion regulation for adolescents and adults. Higher scores indicate greater levels of difficulties in emotion regulation.

participation in treatment

时间窗: From enrollment to the end of treatment at 28 weeks.

Dropout rate from DBT skills training, as well as the percentage of DBT-SUD skills sessions participated in, and the percentage completed homework.

Dialectical Behavior Therapy- Ways of Coping Checklist (DBT-WCCL)

时间窗: From enrollment to the end of treatment at 28 weeks.

It is a 59 item self-rapport questionnaire that assesses both positive and negative methods of coping with stressful situations including problem-focus, seeking social support, blaming self, blaming others, wishful thinking, and avoidance as well as DBT skills use on 4-point likert scale: 0 = Never Used, 1= Rarely Used, 2= Sometimes Used, 3 = Regularly Used. The questionnaire is divided into 2 subscales: 1) DBT skills subscale that consists of Nine items represent emotion regulation skills, seven represent interpersonal effectiveness skills, five depict mindfulness skills, 19 represent crisis survival skills, two depict reality acceptance skills (0-114). and 2) Dysfunctional Coping Subscale that consist of 17 items referring to dysfunctional behavior in general along with items referring more specifically to blaming others (0-63).

次要结局

  • Diary card(From enrollment to the end of treatment at 28 weeks.)
  • Qualitative interview guide - DBT skills training ASD(From enrollment to the end of treatment at 28 weeks.)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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