Autism Spectrum DisorderDASHBOARDNCT05502484
Development of Self-regulation by Dialectial Behavioural Therapy in Adults With Autism
A study testing Integrative Dialectical Behavioural Therapy (DBT) in people with Autism Spectrum Disorder and Regulation, Self, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Individuals with autism spectrum disorder (ASD) are at risk to develop more pervasive emotion-dysregulation. In this study experiences of adults with ASD and severe emotion dysregulation with Integrative Dialectical Behaviour Therapy (DBT) and the mechanisms and processes that hinder and advance the pathway to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorder, Regulation, Self
- What is being tested?
- Integrative Dialectical Behavioural Therapy (DBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2021to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Severe, current psychotic and manic symptoms, severe substance abuse disorder and eating disorder, requiring other specialized treatment first.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Dimence mental health institute
Deventer, Gelderland, 7416 SB
About this study
Official title: Potential Effectiveness of Integrative Dialectical Behavioural Therapy for Adults With Autism and the Role of Sensory Hyper- and Hyposensitivity and Interoceptive BOdy-Awareness in Self-Regulation Development
Individuals with autism spectrum disorder (ASD) are at risk to develop more pervasive emotion-dysregulation. In this study experiences of adults with ASD and severe emotion dysregulation with Integrative Dialectical Behaviour Therapy (DBT) and the mechanisms and processes that hinder and advance the pathway to recovery will be studied, in order to make the treatment more tailored and effective for this target group.
Read the detailed description
Individuals with autism spectrum disorder (ASD) are at risk to develop more pervasive emotion-dysregulation and in conjunction with that they also show more maladaptive coping compared to non-autistic people. Sensory differences and impaired interoceptive body-awareness may influence emotion-dysregulation. Maladaptive coping is reflected by a variety of harmful behaviours, particularly strong social avoidance, rumination, obsessive-compulsive symptoms, disordered eating, substance abuse, agitation, non-suicidal-self-injury (NSSI), and suicidal ideation and behaviour. For a part of these individuals, treatment as usual does not have any effect at all, causing a vicious circle of isolation, demoralization, life-long psychiatric treatments, and crisis. DBT is an empirically supported psychotherapy to treat severe emotion-dysregulation. An effective inpatient treatment for adults with ASD and severe emotion-dysregulation is lacking, as well insight in the development of the process of self-regulation, particularly the role of sensory hyper- and hyposensitivity and interoceptive body-awareness. Therefore, an integrative, mostly inpatient treatment program based on DBT is developed and outcomes will be evaluated in the currently presented research. Standard DBT is used, adapted to adults with ASD, and augmented with a body-oriented DBT-skills training, because of their possible impairments of interoceptive body-awareness. Experiences of participants with the treatment program, the mechanisms and processes that hinder and advance the pathway to recovery will be studied, in order to make the treatment more tailored and effective for this target group.
The first aim is to quantify the effectiveness of integrative DBT in adults with ASD and difficult to treat severe emotion-dysregulation and maladaptive coping (primary outcome measure). The second aim is to determine the improvements over time in sensory hyper- and hyposensitivity, interoceptive body-awareness, cognitive and behavioural emotion-regulation, and well-being. Moreover, we will explore how (full and partial) responders, non-responders and deteriorators will differ with regard to autistic traits, PTSS-symptoms, sensory hyper- and hyposensitivity and interoceptive body-awareness. The third aim is to determine how qualitative findings regarding patients' experiences with integrative DBT enhance the deeper understanding of the quantitative clinical outcomes, in order to get insight in the process and sustainability of self-regulation, and to make the treatment more tailored and effective in the pathway to recovery.
A mixed-methods strategy consisting of three elements is executed:
- A randomized, multiple-baseline single-case design with staggered baselines of 4, 6, or 8 weeks (randomized allocation) and daily measurements of emotion dysregulation.
- A quasi-experimental design with 5 measurements with questionnaires at baseline (T0), start outpatient DBT pretreatment of 8 weeks (T1), start inpatient DBT of 40 weeks (T2), end inpatient DBT (T3), and end follow-up of 24 weeks (T4).
- A qualitative study consisting of interviews with 30 participants.
- Conditions
- Autism Spectrum Disorder, Regulation, Self
- Being tested
- Integrative Dialectical Behavioural Therapy (DBT)
- Keywords
- Autism Spectrum Disorder (ASD), dialectical behavioural therapy (DBT), self-regulation, emotion-dysregulation, body-awareness, interoception, sensory hypersensitivity, sensory hyposensitivity, non-suicidal self-injury (NSSI), suicidal ideation, suicidal behaviour, coping skills
- Medical subject headings
- Autism Spectrum Disorder, Self-Control, Self-Injurious Behavior, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative Dialectical Behavioural Therapy (DBT)Behavioural
8 weeks outpatient pre-treatment DBT followed by integrative, inpatient DBT of 40 weeks, using standard DBT, augmented with an experience-oriented, body-oriented skills training based on DBT-principles by trained DBT-therapists, and a follow-up phase of 12 weeks outpatient aftercare (maximal 8 sessions individual DBT and 4 booster sessions) and 12 weeks no DBT. The inpatient treatment takes place in a living environment that is based on the principles of DBT and takes into account several aspects of autism.
| Study group | Role | What they receive |
|---|---|---|
| 4 weeks baseline followed by Integrative DBT | Experimental | Integrative Dialectical Behavioural Therapy (DBT) consisting of 8 weeks outpatient pretreatment DBT, 40 weeks inpatient DBT, 24 weeks follow-up including 12 weeks after care DBT and 12 weeks no DBT. Receives: Behavioral: Integrative Dialectical Behavioural Therapy (DBT) |
| 6 weeks baseline followed by Integrative DBT | Experimental | Integrative Dialectical Behavioural Therapy (DBT) consisting of 8 weeks outpatient pretreatment DBT, 40 weeks inpatient DBT, 24 weeks follow-up including 12 weeks after care DBT and 12 weeks no DBT. Receives: Behavioral: Integrative Dialectical Behavioural Therapy (DBT) |
| 8 weeks baseline followed by Integrative DBT | Experimental | Integrative Dialectical Behavioural Therapy (DBT) consisting of 8 weeks outpatient pretreatment DBT, 40 weeks inpatient DBT, 24 weeks follow-up including 12 weeks after care DBT and 12 weeks no DBT. Receives: Behavioral: Integrative Dialectical Behavioural Therapy (DBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maladaptive coping: using harmful behaviours
The diary card consists of four Likert scale questions related to standard categories in DBT, such as suicidality, NSSI, substance abuse, and in addition rumination. Scores for each of the constructs will be obtained on a range from 0 - 5: 0 = no urge until 5 = very much urge and a measure of performance of the maladaptive coping (no/yes).
Measured: Change during inpatient treatment (phase C, 40 weeks)
Secondary outcomes (9)
Non Suicidal Self Injury (NSSI)
NSSI will be assessed by the Self-Injury Questionnaire-Treatment Related (SIQ-TR, Dutch version: Zelfverwondingsvragenlijst; Claes \& Vandereycken, 2007). The SIQ-TR addresses five common forms of NSSI (scratching, bruising, cutting, burning and biting), the frequency, duration and pain experience of NSSI. There is an open question in which other self-injurious behaviour can be recorded, that is not standard mentioned (e.g., head banging).
Measured: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
Suicidal ideation
Suicidal ideation will be assessed by the Suicidal Ideation Attributes Scale (SIDAS, Dutch version, Van Spijker et al., 2014). The SIDAS is a 5-item scale assessing frequency (item 1), controllability (item 2), closeness to attempt (item 3), distress (item 4), and interference with daily activities (item 5) on 10-point scales over the past month.
Measured: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
Interoceptive body-awareness
Interoceptive body-awareness will be assessed by the Multidimensional Assessment of Interoceptive Awareness, Dutch version (MAIA-2, Mehling et al., 2018).
The MAIA is a multidimensional self-report measure of interoceptive body-awareness consisting of 37 items and 8 scales: Noticing, not ignoring, not worrying, attention regulation, emotional awareness, self-regulation, listening, trusting.
Measured: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
Emotion-dysregulation
Emotion-dysregulation will be assessed by the Difficulties in Emotion Regulation Scale (DERS, Gratz \& Roemer, 2004; Dutch translation: Neumann \& Koot, 2010).
The DERS is an self-report measure consisting of 36 items, and designed to assess multiple aspects of emotion-dysregulation.
Measured: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
Cognitive emotion-regulation
Cognitive emotion-regulation will be assessed by the Cognitive Emotion Regulation Questionnaire (CERQ, Garnefski et al., 2001; Garnefski, Kraaij \& Spinhoven, 2002; Garnefski \& Kraaij, 2006). The CERQ consists of 9 scales with 4 items each that can be answered on a 5-point Likert scale ranging from 0 (almost never) to 5 (almost always). For each subscale score the 4 items are added (range 4 to 20), indicating the extent to which a certain strategy is used. The CERQ subscales are: self-blame, other-blame, rumination, catastrophizing (more maladaptive strategies), and acceptance, positive refocusing, refocus on planning, positive reappraisal, putting into perspective (more adaptive strategies).
Measured: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
Behavioural emotion-regulation
Behavioural emotion-regulation will be measured by the Behavioural Emotion Regulation Questionnaire (BERQ, Garnefski \& Kraaij, 2019). The BERQ consists of 5 scales with 4 items each that can be answered on a 5-point Likert scale ranging from 0 (almost never) to 5 (almost always). For each subscale score the 4 items are added (range 4 to 20). The BERQ subscales are seeking distraction, actively approaching and seeking social support, and withdrawal and ignoring.
Measured: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
Sensory sensitivity
Hyper- and hyposensitivity will be measured by the Dutch Glasgow Sensory Questionnaire (GSQ-NL) (Kuiper et al., 2019). It consists of 42 self-reported questions scored on a 5-point Likert scale ranging from 0 (never) to 4 (always). There are six items representing each modality (visual, auditory, gustatory, olfactory, tactile, vestibular and proprioception), half measuring hypersensitivity and half measuring hyposensitivity.
Measured: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
Well-being
Well-being will be measured by the Mental Health Continuum - Short Form (MHC-SF, Dutch version). The MHC-SF comprises 14 items, which represent emotional well-being, psychological well-being, and social well-being. Respondents indicate the frequency of experienced feelings in the last month on a 6-point scale ranging from 0 (never) to 5 (every day).
Measured: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
Maladaptive coping: using harmful behaviours
The diary card consists of four Likert scale questions related to standard categories
Measured: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during follow-up (Phase D: 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Jan 2021
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (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.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized multiple baseline design with staggered starts (randomized allocation to a baseline length of 4, 6, or 8 weeks) before starting the treatment (integrative Dialectical Behavioural Therapy).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dimence mental health institute
- Responsible party
- Sponsor
- Investigators
- Ella Lobregt-van Buuren, MSc, Principal investigator, Dimence mental health instituteNanda Lambregts-Rommelse, PhD, Study chair, Radboud University Medical CenterWouter Staal, PhD, Study chair, Radboud University Medical CenterLisette Verhoeven, PhD, Study chair, Dr. Leo KannerhuisPeter Goossens, PhD, Study chair, Dimence mental health institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502484
- Sponsor's protocol ID
- DASHBOARD
- Acronym
- DASHBOARD
- Status last verified
- May 2022
- First submitted
- 28 Jun 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: see: https://dmp.radboudumc.nl/plans/93902
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Effectiveness of Integrative Dialectical Behavioural Therapy for Adults With Autism and the Role of Sensory Hyper- and Hyposensitivity and Interoceptive BOdy-Awareness in Self-Regulation Development
- ClinicalTrials.gov ID
- NCT05502484
- Acronym / sponsor ID
- DASHBOARD / DASHBOARD
- Conditions
- Autism Spectrum Disorder, Regulation, Self
- Keywords
- Autism Spectrum Disorder (ASD), dialectical behavioural therapy (DBT), self-regulation, emotion-dysregulation, body-awareness, interoception, sensory hypersensitivity, sensory hyposensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dimence mental health institute
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 16 Aug 2022 (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.
Individuals with autism spectrum disorder (ASD) are at risk to develop more pervasive emotion-dysregulation. In this study experiences of adults with ASD and severe emotion dysregulation with Integrative Dialectical Behaviour Therapy (DBT) and the mechanisms and processes that hinder and advance the pathway to recovery will be studied, in order to make the treatment more tailored and effective for this target group.
Detailed description
Individuals with autism spectrum disorder (ASD) are at risk to develop more pervasive emotion-dysregulation and in conjunction with that they also show more maladaptive coping compared to non-autistic people. Sensory differences and impaired interoceptive body-awareness may influence emotion-dysregulation. Maladaptive coping is reflected by a variety of harmful behaviours, particularly strong social avoidance, rumination, obsessive-compulsive symptoms, disordered eating, substance abuse, agitation, non-suicidal-self-injury (NSSI), and suicidal ideation and behaviour. For a part of these individuals, treatment as usual does not have any effect at all, causing a vicious circle of isolation, demoralization, life-long psychiatric treatments, and crisis. DBT is an empirically supported psychotherapy to treat severe emotion-dysregulation. An effective inpatient treatment for adults with ASD and severe emotion-dysregulation is lacking, as well insight in the development of the process of self-regulation, particularly the role of sensory hyper- and hyposensitivity and interoceptive body-awareness. Therefore, an integrative, mostly inpatient treatment program based on DBT is developed and outcomes will be evaluated in the currently presented research. Standard DBT is used, adapted to adults with ASD, and augmented with a body-oriented DBT-skills training, because of their possible impairments of interoceptive body-awareness. Experiences of participants with the treatment program, the mechanisms and processes that hinder and advance the pathway to recovery will be studied, in order to make the treatment more tailored and effective for this target group.
The first aim is to quantify the effectiveness of integrative DBT in adults with ASD and difficult to treat severe emotion-dysregulation and maladaptive coping (primary outcome measure). The second aim is to determine the improvements over time in sensory hyper- and hyposensitivity, interoceptive body-awareness, cognitive and behavioural emotion-regulation, and well-being. Moreover, we will explore how (full and partial) responders, non-responders and deteriorators will differ with regard to autistic traits, PTSS-symptoms, sensory hyper- and hyposensitivity and interoceptive body-awareness. The third aim is to determine how qualitative findings regarding patients' experiences with integrative DBT enhance the deeper understanding of the quantitative clinical outcomes, in order to get insight in the process and sustainability of self-regulation, and to make the treatment more tailored and effective in the pathway to recovery.
A mixed-methods strategy consisting of three elements is executed:
- A randomized, multiple-baseline single-case design with staggered baselines of 4, 6, or 8 weeks (randomized allocation) and daily measurements of emotion dysregulation.
- A quasi-experimental design with 5 measurements with questionnaires at baseline (T0), start outpatient DBT pretreatment of 8 weeks (T1), start inpatient DBT of 40 weeks (T2), end inpatient DBT (T3), and end follow-up of 24 weeks (T4).
- A qualitative study consisting of interviews with 30 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized multiple baseline design with staggered starts (randomized allocation to a baseline length of 4, 6, or 8 weeks) before starting the treatment (integrative Dialectical Behavioural Therapy).
| Arm | Type | Receives |
|---|---|---|
| 4 weeks baseline followed by Integrative DBT | Experimental | Behavioral: Integrative Dialectical Behavioural Therapy (DBT)Integrative Dialectical Behavioural Therapy (DBT) consisting of 8 weeks outpatient pretreatment DBT, 40 weeks inpatient DBT, 24 weeks follow-up including 12 weeks after care DBT and 12 weeks no DBT. |
| 6 weeks baseline followed by Integrative DBT | Experimental | Behavioral: Integrative Dialectical Behavioural Therapy (DBT)Integrative Dialectical Behavioural Therapy (DBT) consisting of 8 weeks outpatient pretreatment DBT, 40 weeks inpatient DBT, 24 weeks follow-up including 12 weeks after care DBT and 12 weeks no DBT. |
| 8 weeks baseline followed by Integrative DBT | Experimental | Behavioral: Integrative Dialectical Behavioural Therapy (DBT)Integrative Dialectical Behavioural Therapy (DBT) consisting of 8 weeks outpatient pretreatment DBT, 40 weeks inpatient DBT, 24 weeks follow-up including 12 weeks after care DBT and 12 weeks no DBT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Severe, current psychotic and manic symptoms, severe substance abuse disorder and eating disorder, requiring other specialized treatment first.
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 |
|---|---|---|
| Integrative Dialectical Behavioural Therapy (DBT)8 weeks outpatient pre-treatment DBT followed by integrative, inpatient DBT of 40 weeks, using standard DBT, augmented with an experience-oriented, body-oriented skills training based on DBT-principles by trained DBT-therapists, and a follow-up phase of 12 weeks outpatient aftercare (maximal 8 sessions individual DBT and 4 booster sessions) and 12 weeks no DBT. The inpatient treatment takes place in a living environment that is based on the principles of DBT and takes into account several aspects of autism. | Behavioural | 4 weeks baseline followed by Integrative DBT, 6 weeks baseline followed by Integrative DBT, 8 weeks baseline followed by Integrative DBT |
Primary outcome
Maladaptive coping: using harmful behaviours
Time frame: Change during inpatient treatment (phase C, 40 weeks)
The diary card consists of four Likert scale questions related to standard categories in DBT, such as suicidality, NSSI, substance abuse, and in addition rumination. Scores for each of the constructs will be obtained on a range from 0 - 5: 0 = no urge until 5 = very much urge and a measure of performance of the maladaptive coping (no/yes).
9 secondary outcomes
Non Suicidal Self Injury (NSSI)
Time frame: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
Suicidal ideation
Time frame: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
Interoceptive body-awareness
Time frame: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
Emotion-dysregulation
Time frame: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
Cognitive emotion-regulation
Time frame: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
Behavioural emotion-regulation
Time frame: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
Sensory sensitivity
Time frame: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
Well-being
Time frame: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during inpatient treatment (Phase C, 40 weeks); during follow-up (Phase D: 24 weeks)
Maladaptive coping: using harmful behaviours
Time frame: Change: during baseline period (Phase A, randomized 4-6-8 weeks); during pre-treatment (Phase B, 8 weeks); during follow-up (Phase D: 24 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Individual participant dataSharing planned: Yes. see: https://dmp.radboudumc.nl/plans/93902
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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. This study is not recruiting at the moment.
Ella Lobregt-van Buuren, MSc principal investigator
Dimence mental health institute
Nanda Lambregts-Rommelse, PhD study chair
Radboud University Medical Center
Wouter Staal, PhD study chair
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative Dialectical Behavioural Therapy (DBT) in people with Autism Spectrum Disorder and Regulation, Self, run by Radboud University Medical Center 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 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maladaptive coping: using harmful behaviours (time frame: Change during inpatient treatment (phase C, 40 weeks)). 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 16 Aug 2022.