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Dialectical Behaviour Group Therapy for Adults With Intellectual Disabilities

Primary Purpose

Intellectual Disability

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Adapted Dialectical Behaviour Therapy
Sponsored by
Dr. Jessica Jones
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intellectual Disability

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Division of Developmental Disabilities, 191 Portsmouth Avenue

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DBT Group

Control Arm

Arm Description

Adapted Dialectical Behaviour Therapy

People in this group will receive treatment as usual

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change in Novaco Anger Scale: Part B (Provocation Index)(Novaco, 2003)
Psychometric measure of anger dyscontrol as part of total anger scale: Total items 25 (range 25-100), responses ranging from 1 to 4, where 1 is not at all angry, 2 is a little angry, 3 is fairly angry and 4 is very angry. NAS-PI were recoded so that higher scores in every case indicated greater difficulties in anger control (i.e., greater anger dyscontrol).
Change in Reiss Scale of Dual Diagnosis 38Q (IDS, 1987)
Psychometric measure of psychiatric illness in individuals with intellectual disabilities: Total items 26 (range 26-78), responses ranging from 1 to 3, where 1 is no problem, 2 is problem and 3 is always a problem. REISS items were recoded so that higher scores in every case indicated greater problems with mental health issues ( i.e. psychopathology.)
Change in Adapted Emotion Regulation Checklist (Adapted With Permission From Dante Cicchetti by Jessica Jones)
Psychometric adapted measure of emotional regulation for informants. Given to caregivers to report on changes in observed emotional regulation. Total items 24 (range 24 - 96) responses ranging from 1 to 4, where 1 is never, 2 is sometimes, 3 is often and 4 is almost always. ERC items were recoded so that higher scores in every case indicated greater emotional regulation.
Global Impression of Change: Percentage of Participants Reporting Improvement
Adapted measure of clinical treatment change for informant: Participants were asked for perceived degree of change post group with total overall change; responses ranging from no change (identified problem got worse), to somewhat better (better but no noticeable change), to better (better but the change has not made a significant difference), to moderately better (slight improved difference) to much better (definite improvement and made a significant difference). GIC items were collapsed either into two groups: no change or change (somewhat better, better, moderately better and much better); responses were analyzed in percentages in either group.

Full Information

First Posted
September 12, 2016
Last Updated
May 22, 2020
Sponsor
Dr. Jessica Jones
Collaborators
Providence Care
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1. Study Identification

Unique Protocol Identification Number
NCT02919826
Brief Title
Dialectical Behaviour Group Therapy for Adults With Intellectual Disabilities
Official Title
Adapting and Evaluating Dialectical Behaviour Group Therapy for Adults With Dual Diagnosis (Intellectual Disabilities With Psychiatric Disorder)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Jessica Jones
Collaborators
Providence Care

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine the feasibility and effectiveness of a RCT of an adapted DBT group delivered to individuals with ID and emotional dysregulation.
Detailed Description
1.2 Introduction This pilot intervention attempts to deliver and evaluate an adapted Dialectical Behavior Therapy (DBT) in group format. It is hypothesized that the strategies taught through this adapted modality will increase adults with dual diagnosis skills in managing difficult situations and their emotional reactions, thereby decreasing risk of crisis and ultimately demands placed on the mental health service system. 1.3 Research Questions: Four key questions are addressed within this project: Can adults with intellectual disabilities learn and retain knowledge and skills presented in an adapted DBT group program? Do participants report positive increases in self-esteem and greater engagement in social situations following group participation? Are there decreases in signs and symptoms of mental health issues i.e. anxiety and depression and improvements in challenging behavior following completion of the dialectical behavior group therapy program? Does the program provide any benefit to caregivers? (e.g., are the able to de-escalate "crisis" situations quicker? Do caregivers feel it provides them tools to use when the client experiences distress? Does it lessen the caregivers stress?) 2. Methods 2.1 Research Design: Building upon the DBT adaptation work performed in the United States by Charleton and Dykstra (2011), it is necessary to further refine this intervention to increase its feasibility and viability as a treatment modality for the adult population with dual diagnosis. Using a mixed-methods approach within this current intervention allows exploration of DBT group therapy efficacy for adult with ID and emerging mental health/behavioural issues. 2.2 Recruitment: Participants and caregivers will be invited to participate through the use of local advertising at partnering agencies and through expression of previous interest to clinicians involved. Information brochures/flyers will be distributed to individuals who have expressed an interest in counseling services and may or may not be receiving services at the time. Once participants have been identified they will have the opportunity to self-select a caregiver who they would like to assist them in the groups. The caregivers will receive a letter of information and consent form requesting their participation. All participants will be screened for eligibility and attainment of consent for involvement will include the use of a multi-modality approach. Agencies to be recruited: Ongwanada, Providence Care MHS DDCOT, Christian Horizons, Community Living Kingston, Developmental Services Leeds and Grenville (DSLG), Pathways 2.3. Procedure Recruit Screen for Eligibility Obtain Written Consent (to be confirmed at Pre-Assessment) Complete Pre-Assessment and confirm informed Consent a. At acceptance into the study, individuals will be assigned alpha-numeric symbols on all data documents to ensure patient confidentiality and ensure individuals are unidentifiable to research team. Individuals will be encouraged to use first names only during group sessions and all identifiers (name tags, sign in sheets) will be destroyed at the end of the treatment trial. Once have n=12 participants, Randomize into Group A Intervention or Control Send info package with date/location of group Group A (Duration: 12 weeks) a. Divided into 3 modules (Distress Tolerance; Emotion Regulation; Interpersonal Effectiveness, with Mindfulness integrated into each Post Assessment of Group A Participants (n=6) and n=6 new participants Repeat steps 4 to 8 for Group B and C 12-week intervention and control groups. 2.6 Analysis: Global and individual change question analyses will be conducted within a mixed method approach using SPSS 22. Measures of pre-post group findings will be evaluated using paired t-tests and ANOVAS, if applicable. Structured interview data will be analyzed using thematic analysis where qualitative themes will be summarized and consolidated into possible areas addressing curriculum content, therapeutic process, skill application and overall group therapy feedback

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DBT Group
Arm Type
Experimental
Arm Description
Adapted Dialectical Behaviour Therapy
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
People in this group will receive treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Adapted Dialectical Behaviour Therapy
Intervention Description
12 weekly sessions of DBT group therapy
Primary Outcome Measure Information:
Title
Change in Difficulties in Emotional Regulation Scale (Gratz & Roemner, 2004)
Description
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).
Time Frame
Pre treatment and 12 week post treatment
Secondary Outcome Measure Information:
Title
Change in Novaco Anger Scale: Part B (Provocation Index)(Novaco, 2003)
Description
Psychometric measure of anger dyscontrol as part of total anger scale: Total items 25 (range 25-100), responses ranging from 1 to 4, where 1 is not at all angry, 2 is a little angry, 3 is fairly angry and 4 is very angry. NAS-PI were recoded so that higher scores in every case indicated greater difficulties in anger control (i.e., greater anger dyscontrol).
Time Frame
Pre treatment and 12 week post treatment
Title
Change in Reiss Scale of Dual Diagnosis 38Q (IDS, 1987)
Description
Psychometric measure of psychiatric illness in individuals with intellectual disabilities: Total items 26 (range 26-78), responses ranging from 1 to 3, where 1 is no problem, 2 is problem and 3 is always a problem. REISS items were recoded so that higher scores in every case indicated greater problems with mental health issues ( i.e. psychopathology.)
Time Frame
Pre treatment and 12 week post treatment
Title
Change in Adapted Emotion Regulation Checklist (Adapted With Permission From Dante Cicchetti by Jessica Jones)
Description
Psychometric adapted measure of emotional regulation for informants. Given to caregivers to report on changes in observed emotional regulation. Total items 24 (range 24 - 96) responses ranging from 1 to 4, where 1 is never, 2 is sometimes, 3 is often and 4 is almost always. ERC items were recoded so that higher scores in every case indicated greater emotional regulation.
Time Frame
Pretreatment and 12 week post treatment
Title
Global Impression of Change: Percentage of Participants Reporting Improvement
Description
Adapted measure of clinical treatment change for informant: Participants were asked for perceived degree of change post group with total overall change; responses ranging from no change (identified problem got worse), to somewhat better (better but no noticeable change), to better (better but the change has not made a significant difference), to moderately better (slight improved difference) to much better (definite improvement and made a significant difference). GIC items were collapsed either into two groups: no change or change (somewhat better, better, moderately better and much better); responses were analyzed in percentages in either group.
Time Frame
12 week Post Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Diagnosis of Autism Spectrum Disorder Profound or Severe Intellectual Disability Acute psychosis interfering with daily functioning
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Jones, PhD
Organizational Affiliation
Queen's University, Kingston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Developmental Disabilities, 191 Portsmouth Avenue
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7M 8A6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Dialectical Behaviour Group Therapy for Adults With Intellectual Disabilities

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