An interventional study of Integrative Dialectical Behavioural Therapy (DBT) in Autism Spectrum Disorder and Regulation, Self, sponsored by Radboud University Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-16.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment
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.
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:
1,755 studies on the registry are indexed under Autism Spectrum Disorder; 507 are open to participants now.
This study's planned enrollment of 30 is below the median of 52 across 1,391 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Radboud University Medical Center is the lead sponsor of 984 studies on the registry; 135 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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The inclusion criteria to enroll in the study are the same as the inclusion criteria for integrative DBT. Inclusion Criteria:
Exclusion Criteria:
- Severe, current psychotic and manic symptoms, severe substance abuse disorder and eating disorder, requiring other specialized treatment first.
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.
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.
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.
Behavioral: 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.
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).
Time frame: Change during inpatient treatment (phase C, 40 weeks)
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).
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
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.
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
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.
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
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.
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
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).
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
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.
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
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.
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
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).
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
The diary card consists of four Likert scale questions related to standard categories
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)
Plan to share: Yes — see: https://dmp.radboudumc.nl/plans/93902
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: After data are published, possibly in 2025.
Access criteria: conditions for access to the data are described here: https://www.dimencegroep.nl/onderzoek/sites/default/files/documenten/richtlijn_databeheerplan_def_092018_0.pdf
Data sharing details ↗ · dmp.radboudumc.nl
No publications or documents are linked to this record.
Started Jan 2021 (actual). Primary completion is estimated for Jul 2025, 54 months after the start.
Of 801 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 54 months is above that.
Counting every sponsor, half of 825 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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