Clinical trial NCT02919826: 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
Overall status: COMPLETED
Phase: NA
Conditions: Intellectual Disability
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Providence Health & Services
First posted: 2016-09-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. Can adults with intellectual disabilities learn and retain knowledge and skills presented in an adapted DBT group program?
2. Do participants report positive increases in self-esteem and greater engagement in social situations following group participation?
3. 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?
4. 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

1. Recruit
2. Screen for Eligibility
3. Obtain Written Consent (to be confirmed at Pre-Assessment)
4. 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.
5. Once have n=12 participants, Randomize into Group A Intervention or Control
6. Send info package with date/location of group
7. Group A (Duration: 12 weeks)

   a. Divided into 3 modules (Distress Tolerance; Emotion Regulation; Interpersonal Effectiveness, with Mindfulness integrated into each
8. Post Assessment of Group A Participants (n=6) and n=6 new participants
9. 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

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

Primary outcomes:
measure: Change in Difficulties in Emotional Regulation Scale (Gratz & Roemner, 2004)
timeFrame: Pre treatment and 12 week post treatment
Secondary outcomes:
measure: Change in Novaco Anger Scale: Part B (Provocation Index)(Novaco, 2003)
timeFrame: Pre treatment and 12 week post treatment
measure: Change in Reiss Scale of Dual Diagnosis 38Q (IDS, 1987)
timeFrame: Pre treatment and 12 week post treatment
measure: Change in Adapted Emotion Regulation Checklist (Adapted With Permission From Dante Cicchetti by Jessica Jones)
timeFrame: Pretreatment and 12 week post treatment
measure: Global Impression of Change: Percentage of Participants Reporting Improvement
timeFrame: 12 week Post Treatment
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Division of Developmental Disabilities, 191 Portsmouth Avenue
state: Ontario
Study officials:
affiliation: Queen's University, Kingston
name: Jessica Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: