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

NCT07786883 | Recruiting

• 1 other identifier: 2025/666
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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:

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

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• Maladaptive Emotion Regulation Strategies (MERS) measured assessed by the DBT diary (Linehan, 2016)

  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)

  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 Outcomes (3)

• Social behaviour

  At start of baseline (T1), at end of treatment phase at 10 months (T2)

• Emotion regulation

  At the start of the baseline phase (T1), at the end of the treatment phase at 10 months (T2)

• Generic psychopathology and functioning

  At the start of the baseline phase (T1), at the end of the treatment phase at 10 months (T2)

Study Arms (1)

Dialectic Behavioural Therapy

EXPERIMENTAL

Dialectic Behavioural Therapy for emotion regulation, adapted to individuals with Autism Spectrum Disorder, given for 10 months

Behavioral: Dialectic Behavioural Therapy

Interventions

Dialectic Behavioural Therapy BEHAVIORAL

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

Dialectic Behavioural Therapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• GGZ Friesland: lead

Study Sites (1)

GGZ Friesland

Leeuwarden, Provincie Friesland, 8934AD, Netherlands

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Emma Smeenge

CONTACT

+31610779265; emma.smeenge@ggzfriesland.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be a Single Case Experimental Design (SCED). Therefore each case functions as their own control. Daily diary data will be analysed, just like secondary questionnaire outcomes.

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 26, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)