NCT07021274

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Aug 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Aug 2025Feb 2027

First Submitted

Initial submission to the registry

May 19, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 20, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

May 19, 2025

Last Update Submit

July 10, 2025

Conditions

Keywords

Autisimemotion regulationDBT skills trainingadultsASDFeasibilityAutism spectrum disorder

Outcome Measures

Primary Outcomes (3)

  • Difficulties in emotion regulation scale (DERS) - 8

    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.

    From enrollment to the end of treatment at 28 weeks.

  • participation in treatment

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

    From enrollment to the end of treatment at 28 weeks.

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

    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).

    From enrollment to the end of treatment at 28 weeks.

Secondary Outcomes (2)

  • 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.

Study Arms (1)

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.

Behavioral: DBT skills training adjusted to autistic needs

Interventions

Adjustments to fit the specific learning style of people with autism. Simplified skills - fewer words, ,more pictures, autism relevant examples. Hands- on training using props and role play. adjustments so sensory sensitivities.

Participate in DBT skills training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 17.
  • Cognitive disability Intelliganve quotient (IQ) \<85

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Bargiela S, Steward R, Mandy W. The Experiences of Late-diagnosed Women with Autism Spectrum Conditions: An Investigation of the Female Autism Phenotype. J Autism Dev Disord. 2016 Oct;46(10):3281-94. doi: 10.1007/s10803-016-2872-8.

    PMID: 27457364BACKGROUND
  • Ritschel LA, Guy L, Maddox BB. A pilot study of dialectical behaviour therapy skills training for autistic adults. Behav Cogn Psychother. 2022 Mar;50(2):187-202. doi: 10.1017/S1352465821000370. Epub 2021 Sep 23.

    PMID: 34553682BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderEmotional Regulation

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSelf-ControlSocial BehaviorBehavior

Study Officials

  • Egil Jonsbu, MD, PhD

    More And Romsdal Hospital Trust

    STUDY DIRECTOR

Central Study Contacts

Johanna Vigfusdottir, Clinical psychologist

CONTACT

Reidun Hoidal, Clinical psychologist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This study is a mixed-method feasibility study without a control group. With measurements pre and post treatment intervention
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2025

First Posted

June 13, 2025

Study Start

August 20, 2025

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

July 15, 2025

Record last verified: 2025-07