Condition category
Mental and Behavioural Disorders
Date applied
19/04/2019
Date assigned
01/05/2019
Last edited
01/05/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 July 2020

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

01/06/2020

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

01/07/2020

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

http://www.vu.nl

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

01/06/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

01/05/2019: Trial’s existence confirmed by Medical Ethics Committee of VU Medical Centre Amsterdam