Dialectic Behaviour Therapy (DBT) for People With Autism: A Multiple Baseline Single Case Design (DGT-ASS)

August 25, 2026 updated by: GGZ Friesland

Dialectic Behaviour Therapy (DBT) for People With Autism, Emotion Regulation Difficulties and Self-harm Behaviour: A Multiple Baseline Single Case Design

The goal of this experimental study is to test the effectiveness of Dialectic Behavioural Therapy in patients with Autism Spectrum Disorder. The aim questions are:

  1. What is the effect of DBT on maladaptive emotion regulation strategies and emotional well-being in patients with ASD?
  2. Is the use of DBT skills associated with a reduction in maladaptive emotion regulation strategies and an increase of emotional well-being over time?
  3. What are the dynamics over time between maladaptive emotion regulation strategies, emotional well-being and sensory overload?

Participants will:

  • Follow DBT of 10 months
  • Keep a diary on their urge of maladaptive emotion regulation strategies and well-being

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Provincie Friesland
      • Leeuwarden, Provincie Friesland, Netherlands, 8934AD
        • Recruiting
        • GGZ Friesland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • DSM-5 diagnosis of ASD
  • Sufficient understanding, as demonstrated in conversation with intake therapist;
  • Explicit behavioural problems, which, according to patient and therapist, lead to functional problems (like suicidal ideation, auto mutilation, emotional outburst and interpersonal conflicts);
  • BMI > 17;
  • Commitment to the therapy and shared goals as assessed by intake therapist;

Exclusion Criteria:

  • Antisocial behaviour which interrupts the group climate;
  • Presence of a trauma-related disorder that is likely to interfere with the ability to engage effectively in DBT or that requires specialized trauma-focused treatment prior to or alongside DBT as assessed by intake team;
  • Excessive dependency on substances for which no parallel appropriate policy can be made;
  • Diagnosis of psychotic disorder if not stable;
  • Diagnosed with bipolar disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dialectic Behavioural Therapy
Dialectic Behavioural Therapy for emotion regulation, adapted to individuals with Autism Spectrum Disorder, given for 10 months
Behavioral: Dialectic Behavioural Therapy
Dialectic Behavioural Therapy for emotion regulation, adapted to individuals with Autism Spectrum Disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maladaptive Emotion Regulation Strategies (MERS) measured assessed by the DBT diary (Linehan, 2016)
Time Frame: From enrollment to end of treatment at 10 months

MERS is the average of the urge to six maladaptive emotion regulation strategies:

  1. suicidal thoughts/behaviours
  2. self-harm,
  3. eating problems
  4. substance abuse
  5. anger outburst
  6. other All emotion regulation strategies are measured on a scale from 0 - 100. MERS will be created by adding scores of the six strategies together and divide it by 6.
From enrollment to end of treatment at 10 months
Emotional well-being as assessed by the DBT diary (Linehan, 2016)
Time Frame: From enrollment to end of treatment at 10 months
The daily diary measures emotional suffering and happiness on a scale from 0 - 100. Emotional suffering is inverted, following the logic that higher emotional suffering means lower emotional well-being. The variable well-being is created by averaging the invert of emotional suffering and happiness.
From enrollment to end of treatment at 10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social behaviour
Time Frame: At start of baseline (T1), at end of treatment phase at 10 months (T2)
As measured by the Vragenlijst Inventarisatie van Sociaal gedrag bij Volwassenen (VIS-V) (Horwitz et al. 2013). The VIS-V is a 44-item questionnaire that assess social behaviour, with answers ranging from 0 (= not applicable) to 2 (=cleary applicable). Higher scores mean lower social behaviour.
At start of baseline (T1), at end of treatment phase at 10 months (T2)
Emotion regulation
Time Frame: At the start of the baseline phase (T1), at the end of the treatment phase at 10 months (T2)
As measured with the Difficulties in Emotion Regulation Scale (DERS) (Gratz & Roemer, 2004). The DERS is a 36-item questionnaire with 5-point Likert answers, ranging from "almost never" to "almost always".
At the start of the baseline phase (T1), at the end of the treatment phase at 10 months (T2)
Generic psychopathology and functioning
Time Frame: At the start of the baseline phase (T1), at the end of the treatment phase at 10 months (T2)
As measured with the Outcome Questionnaire-45 (OQ-45) (De Jong et al., 2008). The OQ-45 is a 45-item questionnaire, with answers ranging from never (0) to almost always (4). Some items are mirrored.
At the start of the baseline phase (T1), at the end of the treatment phase at 10 months (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GGZ Friesland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

August 12, 2026

First Submitted That Met QC Criteria

August 25, 2026

First Posted (Actual)

August 26, 2026

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 25, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/666

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To protect the participants of the study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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