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NCT Number: NCT07786883

Dialectic Behaviour Therapy (DBT) for People With Autism: 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

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GGZ Friesland

Leeuwarden, Provincie Friesland, 8934AD, Netherlands

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Dialectic Behavioural Therapy

Behavioral

Dialectic Behavioural Therapy for emotion regulation, adapted to individuals with Autism Spectrum Disorder

Primary outcomes

  1. 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:

    • suicidal thoughts/behaviours
    • self-harm,
    • eating problems
    • substance abuse
    • anger outburst
    • 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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".

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Smeenge

CONTACT

[email protected]

+31610779265

Sponsors and collaborators

Lead sponsor

GGZ Friesland

Other

Registry information

Official study title

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

Acronym: DGT-ASS

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 26, 2026
Registry last updated
Aug 26, 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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