Ignite Creation Date:
2024-05-06 @ 6:00 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05502484
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2022-08-16
First Post:
2022-06-28
Brief Title:
Development of Self-regulation by Dialectial Behavioural Therapy in Adults With Autism
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DASHBOARD
Brief 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 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
1 A randomized multiple-baseline single-case design with staggered baselines of 4 6 or 8 weeks randomized allocation and daily measurements of emotion dysregulation
2 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
3 A qualitative study consisting of interviews with 30 participants
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 A randomized multiple-baseline single-case design with staggered baselines of 4 6 or 8 weeks randomized allocation and daily measurements of emotion dysregulation
2 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
3 A qualitative study consisting of interviews with 30 participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None