Development of Self-regulation by Dialectial Behavioural Therapy in Adults With Autism

NCT05502484 | Unknown DMC

• 1 other identifier: DASHBOARD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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; non-suicidal self-injury (NSSI); suicidal ideation; suicidal behaviour; coping skills

Outcome Measures

Primary Outcomes (1)

• 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).

  Change during inpatient treatment (phase C, 40 weeks)

Secondary Outcomes (9)

• Non Suicidal Self Injury (NSSI)

  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

  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

  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

  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

  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)

Study Arms (3)

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.

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.

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.

Behavioral: Integrative Dialectical Behavioural Therapy (DBT)

Interventions

Integrative Dialectical Behavioural Therapy (DBT) BEHAVIORAL

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.

4 weeks baseline followed by Integrative DBT; 6 weeks baseline followed by Integrative DBT; 8 weeks baseline followed by Integrative DBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old.
• A clinical diagnosis of ASD as diagnosed by a qualified health care professional (in Dutch: BIG registration).
• Non-responding to TAU (treatment as usual) for at least a year.
• IQ ≥ 85, based upon previous levels of education or previous IQ test, when available.
• Consent from the participant to record the DBT sessions on video or audio for supervision and assessing therapy integrity.
• Proficient in the Dutch language.
• Motivation to address problems through integrative DBT.
• Ability to work on treatment goals in collaboration with multiple therapists and counselors and to function in a group of maximal 8 adults with ASD.

You may not qualify if:

• \- Severe, current psychotic and manic symptoms, severe substance abuse disorder and eating disorder, requiring other specialized treatment first.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Dimence mental health institute: collaborator

Study Sites (1)

Dimence mental health institute

Deventer, Gelderland, 7416 SB, Netherlands

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Self-Control; Self-Injurious Behavior; Suicidal Ideation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Social Behavior; Behavior; Behavioral Symptoms; Suicide

Study Officials

• Ella Lobregt-van Buuren, MSc

  Dimence mental health institute

  PRINCIPAL INVESTIGATOR

• Nanda Lambregts-Rommelse, PhD

  Radboud University Medical Center

  STUDY CHAIR

• Wouter Staal, PhD

  Radboud University Medical Center

  STUDY CHAIR

• Lisette Verhoeven, PhD

  Dr. Leo Kannerhuis

  STUDY CHAIR

• Peter Goossens, PhD

  Dimence mental health institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: August 16, 2022
• Study Start: January 1, 2021
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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

Locations

NL (1)