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Completed

NCT Number: NCT04737707

Dialectical Behavior Therapy for Adults With Autism Spectrum Disorders

Dialectical Behavior Therapy (DBT; Linehan, 1993) effectively diminishes emotion dysregulation and self-harm behaviors in a number of disorders. However, to our knowledge, no studies have investigated the efficacy of DBT to treat emotional dysregulation associated with self-harm and suicidal behaviors in adults with ASD without intellectual disability. This randomized controlled study trial aims to assess the efficacy of a 5-month DBT intervention in adults with ASD without intellectual disability who present with self-harm and/or suicidal behaviors.

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Key information

Conditions

Autism Spectrum Disorders Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de psychiatrie

Strasbourg, 67000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years old
  • ASD diagnosis according to the DSM-5
  • IQ ≥ 70
  • Suicidal ideas, suicidal attempts and/or self-harm behaviors 6 months prior to the inclusion
  • Able to understand and consent to the research aims
  • Membership in a health insurance fund

Exclusion criteria

  • complete hospitalization
  • ongoing CBT or DBT
  • past DBT
  • schizophrenia disorders
  • under guardianship

Treatment and study plan

Dialectical Behavior Therapy (DBT)

Other

Dialectical Behavior Therapy (DBT)

Primary outcomes

  1. Difficulties in Emotion Regulation Scale (DERS)

    Time frame: baseline

    The minimum value of the DERS scale is 0 and the maximum is 180. The higher the scores, the more severe the deregulation.

  2. Difficulties in Emotion Regulation Scale (DERS)

    Time frame: at the end of therapy (5 months)

    The minimum value of the DERS scale is 0 and the maximum is 180. The higher the scores, the more severe the deregulation.

  3. Difficulties in Emotion Regulation Scale (DERS)

    Time frame: 11 months follow-up

    The minimum value of the DERS scale is 0 and the maximum is 180. The higher the scores, the more severe the deregulation.

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Dialectical Behavior Therapy for Adults With Autism Spectrum Disorders Without Intellectual Disability: a Randomized Controlled Trial

Acronym: Autisemo

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 4, 2021
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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