Plain English Summary
Background and study aims
Many patients with autism spectrum disorder are treated in long-term specialized care, and suicidal behaviour is an issue that troubles patients, families and specialists in the field and is difficult to treat. At this moment, there is no documented effective therapy for suicidal behaviour in ASD. Dialectical Behaviour Therapy is an efficacious treatment program for chronically impulsive suicidal and/or self-harm behaviour in patients with Borderline Personality Disorder and this study will evaluate the efficacy of Dialectical Behaviour Therapy in patients with an autism spectrum disorder and suicidal behaviour in a randomised controlled trial.
Who can participate?
Patients with autism spectrum disorder, suicidal and/or self-harming behaviour, aged 18 - 65 years
What does the study involve?
The study is the first to test a treatment protocol aimed at reducing self-harm and suicidal behaviour in people with autism spectrum disorder.
What are the possible benefits and risks of participating?
The aimed for benefits are more self-control over strong emotions such as despair and anger and control over self-harm and other suicidal behaviour and suicide attempts.
The medical ethical committee judged the study as “no-increased risk”. The patient can stop the participation in the trial at any moment, without any consequences for the treatment.
Where is the study run from?
1. Parnassia Psychiatric Institute, The Hague, Netherlands
2. Antes Psychiatric Institute, Rotterdam, Netherlands
3. Rivierduinen psychiatric institute, Leiden, Netherlands
4. Lentis psychiatric institute, Groningen, Netherlands
When is the study starting and how long is it expected to run for?
August 2018 to January 2022
Who is funding the study?
Stichting tot Steun VCVGZ (Foundation for VCVGZ Support), Netherlands
Who is the main contact?
1. Prof. Mark van der Gaag (scientific contact), m.vander.gaag@vu.nl
2. Mrs Anne Huntjens (scientific contact), a.huntjens@parnassia.nl
Trial website
Contact information
Type
Scientific
Primary contact
Prof Mark van der Gaag
ORCID ID
http://orcid.org/0000-0002-3525-6415
Contact details
Vrije Universiteit
Department of Clinical Psychology
van der Boechorststraat 7
Amsterdam
2018 BT
Netherlands
+31 20 59 85 74 2
m.vander.gaag@vu.nl
Type
Scientific
Additional contact
Mrs Anne Huntjens
ORCID ID
Contact details
Parnassia Psychiatric Institute
Zoutkeetsingel 40
The Hague
2512 HN
Netherlands
+31614433568
a.huntjens@parnassia.nl
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
NL59497.029.17
Study information
Scientific title
The effect of dialectical behaviour therapy in autism-spectrum patients with suicidality and/ or self-destructive behaviour: a multi-site randomized controlled trial
Acronym
DIASS
Study hypothesis
The primary objective is to evaluate the effect of a short term DBT treatment program (26 weeks) versus treatment as usual, in terms of reduction of suicidal and/or self-harming behaviour in adult outpatients with autism.
A. Other objectives were to determine the efficacy of DBT versus TAU on (a) anxiety, (b) social performance, (b) depression, (c) core symptoms of ASD and (d) quality of life. The DBT dairy card is an assessment technique designed to obtain repeated self-reports.
B. An economic evaluation will determine the cost-effectiveness and cost-utility of the DBT treatment
C. In the intervention study, we will conduct additional research to explore mechanisms of changes in the treatment outcome variables. Variables that are potential predictors, mediators and moderators will be examined, such as: a) emotion regulation; b) strength of the therapeutic alliance; c) difficulties engaging in goal-directed behaviours; d) demographic characteristics; e) alexithymia
Ethics approval
Approved 20/03/2018, Medical Ethics Committee of VU Medical Centre Amsterdam (METc VUmc : BS7, room H-443, P.O Box 7057, 1007 MB Amsterdam, the Netherlands; +31 20 44 45 58 5; metc@vumc.nl), ref: 2017.547 NL59497.029.17
Study design
Single-blind multi-site randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Suicidal ideation, self-harm and suiciadal behaviour in patients with autism-spectrum disorder
Intervention
The study design is a multicentre single-blind randomized controlled trial with two arms. The experimental arm is Dialectical Behaviour Therapy and the active control arm is individual psychotherapy.
The study population are 128 adult outpatients with autism spectrum disorder with suicidal and/or self-harming behaviour in the last year.
The DBT consists of weekly individual cognitive–behavioural therapy sessions and group skills-trainings two times each week during 2.5 hours per session. The order of the topics of each session is based on Linehan’s protocol and is pre-determined: suicidal and self-destructive behaviour, therapy interfering behaviour, quality of life interfering behaviour and generalization of the skills taught in the training. Each therapy session starts with the diary cards that hold all the information concerning the problematic behaviours which are the primary goal of the treatment, but also behaviours that influence the primary goals (such as alcohol and drug use, the urge to self-harm, substance abuse, dissociation, level of applied skills). The skills-training groups lasting 2.5 h per and there are two sessions each week. The skills taught are standard DBT skills and combine self-regulation and change skills, and skills for self-acceptance and acceptance of others: Core mindfulness skills, Interpersonal effectiveness skills, Emotion regulation skills, Crises skills and Radical acceptance. Missed meetings need to be caught up by watching the video recordings that are made of all the training sessions
The control condition is psychotherapy each week. This is a needs-based intervention with shared decision making between the patient and the psychotherapist.
The experimental period is six months.
Randomization is conducted by the independent randomisation bureau of Parnassia Psychiatric Institute with the use of block randomisation with the randomisation software from www.randomizer.org. Research Randomizer (Version 4.0).
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Suicidal ideation measured by the 'Suicidal Ideation Attributes Scale' and self-harm and suicidal behaviour as measured by the 'Lifetime Parasuicide Count'.
Secondary outcome measures
1. Social Anxiety (Social Interaction Anxiety Scale)
2. Depression (Beck Depression Inventory-2)
3. Quality of Life (Manchester Short Assessment of Quality of Life)
4. Social functioning (Personal and Social Performance Scale)
5. Autism symptoms (Autism Spectrum Quotient-28 & Social Responsiveness Scale)
6. Emotion Regulation {Difficulties in Emotion Regulation Scale: mediator)
7. Working Alliance (Working Alliance Questionnaire: mediator)
8. Alexithymia (Toronto Alexithymia Scale: moderator)
9. Utilities (EuroQoL-5D: cost-utilities)
10. Health costs (Trimbos/iMTA questionnaire for costs associated with Psychiatric illness: cost utilities)
Overall trial start date
01/03/2018
Overall trial end date
04/01/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age between 18 and 65 years
2. Meets DSM V criteria for autism spectrum disorder
3. Suicidal ideation above cutoff on SIDAS (score ≥21) and/or level of suicidality/self-harming behavior on the LPC rated as severe (score = 2 on any item)
4. Outpatient status
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
128
Participant exclusion criteria
1. IQ <80
2. Addiction to illicit drugs in need of clinical detoxification
3. Insufficient mastery of the Dutch language
Recruitment start date
23/08/2018
Recruitment end date
01/04/2021
Locations
Countries of recruitment
Netherlands
Trial participating centre
Parnassia Psychiatric Institute
Zoutkeetsingel 40
The Hague
2512 HN
Netherlands
Trial participating centre
Antes psychiatric institute
Maasstadweg 96
Rotterdam
3079 DZ
Netherlands
Trial participating centre
Rivierduinen psychiatric institute
Sandifortdreef 17
Leiden
2333 ZZ
Netherlands
Trial participating centre
Lentis psychiaatric institute
Lagershout E35
Groningen
9740 AC
Netherlands
Sponsor information
Organisation
VU University
Sponsor details
van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31645780463
m.vander.Gaag@vu.nl
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Stichting tot Steun VCVGZ (Foundation for VCVGZ Support)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
We plan to publish the results on the primary outcome and separately on the secondary outcomes.
Another paper will address the issue of mediation of therapy effects by emotion regulation and working alliance and moderation by level of alexithymia.
Finally, cost-utility analyses all be published to address the costs of benefits of dialectical behaviour therapy in suicidal autism spectrum patients.
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date
Intention to publish date
01/06/2022
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list