Dialectical Behaviour Group Therapy for Adults With Intellectual Disabilities

NCT02919826 | Completed Results

• 1 other identifier: PSIY-511-15
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the feasibility and effectiveness of a RCT of an adapted DBT group delivered to individuals with ID and emotional dysregulation.

Conditions

Intellectual Disability

Outcome Measures

Primary Outcomes (1)

• Change in Difficulties in Emotional Regulation Scale (Gratz & Roemner, 2004)

  Psychometric measure of emotional dysregulation: Total items 36 (range 36-180), responses ranging from 1 to 5, where 1 is almost never (0-10%), 2 is sometimes (11- 35%), 3 is about half the time (36-65%), 4 is most of the time (66-90%), and 5 is almost always (91-100%). DERS items were recoded so that higher scores in every case indicated greater difficulties in emotion regulation (i.e., greater emotion dysregulation).

  Pre treatment and 12 week post treatment

Secondary Outcomes (4)

• Change in Novaco Anger Scale: Part B (Provocation Index)(Novaco, 2003)

  Pre treatment and 12 week post treatment

• Change in Reiss Scale of Dual Diagnosis 38Q (IDS, 1987)

  Pre treatment and 12 week post treatment

• Change in Adapted Emotion Regulation Checklist (Adapted With Permission From Dante Cicchetti by Jessica Jones)

  Pretreatment and 12 week post treatment

• Global Impression of Change: Percentage of Participants Reporting Improvement

  12 week Post Treatment

Study Arms (2)

DBT Group

EXPERIMENTAL

Adapted Dialectical Behaviour Therapy

Behavioral: Adapted Dialectical Behaviour Therapy

Control Arm

NO INTERVENTION

People in this group will receive treatment as usual

Interventions

Adapted Dialectical Behaviour Therapy BEHAVIORAL

12 weekly sessions of DBT group therapy

DBT Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Mild or Moderate Intellectual Disability
• Symptoms of emotional and behavioural difficulties e.g. emotional dysregulation
• Dedicated caregiver to accompany and attend all sessions

You may not qualify if:

• Diagnosis of Autism Spectrum Disorder
• Profound or Severe Intellectual Disability
• Acute psychosis interfering with daily functioning

Sponsors & Collaborators

• Dr. Jessica Jones: lead
• Providence Health & Services: collaborator

Study Sites (1)

Division of Developmental Disabilities, 191 Portsmouth Avenue

Kingston, Ontario, K7M 8A6, Canada

Location

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Muhammad Ayub
• Organization: Queen's University

ma84@queensu.ca

613-549-7944

Study Officials

• Jessica Jones, PhD

  Queen's University, Kingston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 29, 2016
• Study Start: August 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: March 1, 2018
• Last Updated: June 2, 2020
• Results First Posted: May 22, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)