Autism Spectrum DisorderDGT-ASSNCT07786883
Dialectic Behaviour Therapy (DBT) for People With Autism: A Multiple Baseline Single Case Design
A study testing Dialectic Behavioural Therapy in people with Autism Spectrum Disorder, run by GGZ Friesland at 1 site in Netherlands.
Trial 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: 1. What is the effect of DBT on maladaptive emotion regulation strategies and emotional well-being in patients with ASD? 2. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Dialectic Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
GGZ Friesland
Leeuwarden, Provincie Friesland, 8934AD
About this study
Official title: 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:
- What is the effect of DBT on maladaptive emotion regulation strategies and emotional well-being in patients with ASD?
- Is the use of DBT skills associated with a reduction in maladaptive emotion regulation strategies and an increase of emotional well-being over time?
- 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
- Conditions
- Autism Spectrum Disorder
- Being tested
- Dialectic Behavioural Therapy
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectic Behavioural TherapyBehavioural
Dialectic Behavioural Therapy for emotion regulation, adapted to individuals with Autism Spectrum Disorder
| Study group | Role | What they receive |
|---|---|---|
| Dialectic Behavioural Therapy | Experimental | Dialectic Behavioural Therapy for emotion regulation, adapted to individuals with Autism Spectrum Disorder, given for 10 months Receives: Behavioral: Dialectic Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
Measured: 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.
Measured: From enrollment to end of treatment at 10 months
Secondary outcomes (3)
Social behaviour
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.
Measured: At start of baseline (T1), at end of treatment phase at 10 months (T2)
Emotion regulation
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".
Measured: At the start of the baseline phase (T1), at the end of the treatment phase at 10 months (T2)
Generic psychopathology and functioning
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.
Measured: At the start of the baseline phase (T1), at the end of the treatment phase at 10 months (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GGZ Friesland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786883
- Sponsor's protocol ID
- 2025/666
- Acronym
- DGT-ASS
- Status last verified
- Jul 2026
- First submitted
- 12 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect the participants of the study
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialectic Behaviour Therapy (DBT) for People With Autism, Emotion Regulation Difficulties and Self-harm Behaviour: A Multiple Baseline Single Case Design
- ClinicalTrials.gov ID
- NCT07786883
- Acronym / sponsor ID
- DGT-ASS / 2025/666
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- GGZ FrieslandUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the effect of DBT on maladaptive emotion regulation strategies and emotional well-being in patients with ASD?
- Is the use of DBT skills associated with a reduction in maladaptive emotion regulation strategies and an increase of emotional well-being over time?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dialectic Behavioural Therapy | Experimental | Behavioral: Dialectic Behavioural TherapyDialectic Behavioural Therapy for emotion regulation, adapted to individuals with Autism Spectrum Disorder, given for 10 months |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectic Behavioural TherapyDialectic Behavioural Therapy for emotion regulation, adapted to individuals with Autism Spectrum Disorder | Behavioural | Dialectic Behavioural Therapy |
Primary outcome
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.
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.
3 secondary outcomes
Social behaviour
Time frame: 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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No. To protect the participants of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectic Behavioural Therapy in people with Autism Spectrum Disorder, run by GGZ Friesland at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Smeenge (+31610779265, emma.smeenge@ggzfriesland.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maladaptive Emotion Regulation Strategies (MERS) measured assessed by the DBT diary (Linehan, 2016) (time frame: From enrollment to end of treatment at 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026; AzTrials last refreshed its copy on 28 Oct 2026.