Intellectual Disability Clinical Trial
Official title:
Adapting and Evaluating Dialectical Behaviour Group Therapy for Adults With Dual Diagnosis (Intellectual Disabilities With Psychiatric Disorder)
NCT number | NCT02919826 |
Other study ID # | PSIY-511-15 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | March 2018 |
Verified date | May 2020 |
Source | Queen's University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine the feasibility and effectiveness of a RCT of an adapted DBT group delivered to individuals with ID and emotional dysregulation.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 2018 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Division of Developmental Disabilities, 191 Portsmouth Avenue | Kingston | Ontario |
Lead Sponsor | Collaborator |
---|---|
Dr. Jessica Jones | Providence Care |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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). | Pre treatment and 12 week post treatment | |
Secondary | 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.) | Pre treatment and 12 week post treatment | |
Secondary | 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. | Pretreatment and 12 week post treatment | |
Secondary | 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. |
12 week Post Treatment |
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