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Intellectual DisabilityNCT02919826

Dialectical Behaviour Group Therapy for Adults With Intellectual Disabilities

A study testing Adapted Dialectical Behaviour Therapy in people with Intellectual Disability, run by Dr. Jessica Jones at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Intellectual Disability
What is being tested?
Adapted Dialectical Behaviour Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
Aug 2016to Mar 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Division of Developmental Disabilities, 191 Portsmouth Avenue

    Kingston, Ontario, K7M 8A6

Other trials in Canada

About this study

Official title: Adapting and Evaluating Dialectical Behaviour Group Therapy for Adults With Dual Diagnosis (Intellectual Disabilities With Psychiatric Disorder)

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

Read the 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?)
  5. 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
  5. 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.
  6. Once have n=12 participants, Randomize into Group A Intervention or Control
  7. Send info package with date/location of group
  8. Group A (Duration: 12 weeks)
  9. Divided into 3 modules (Distress Tolerance; Emotion Regulation; Interpersonal Effectiveness, with Mindfulness integrated into each
  10. Post Assessment of Group A Participants (n=6) and n=6 new participants
  11. 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

Being tested
Adapted Dialectical Behaviour Therapy
Medical subject headings
Intellectual Disability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adapted Dialectical Behaviour TherapyBehavioural

    12 weekly sessions of DBT group therapy

Study groups in NCT02919826
Study groupRoleWhat they receive
DBT GroupExperimentalAdapted Dialectical Behaviour Therapy
Receives: Behavioral: Adapted Dialectical Behaviour Therapy
Control ArmNo interventionPeople in this group will receive treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Pre treatment and 12 week post treatment

Secondary outcomes (4)
  1. 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).

    Measured: Pre treatment and 12 week post treatment

  2. 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.)

    Measured: Pre treatment and 12 week post treatment

  3. 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.

    Measured: Pretreatment and 12 week post treatment

  4. 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.

    Measured: 12 week Post Treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionSep 2017
  4. Study completionMar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02919826
Sponsor's protocol ID
PSIY-511-15
Status last verified
May 2020
First submitted
12 Sep 2016
Last updated
2 Jun 2020
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Adapted Dialectical Behaviour Therapy in people with Intellectual Disability, run by Dr. Jessica Jones at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Difficulties in Emotional Regulation Scale (Gratz & Roemner, 2004) (time frame: Pre treatment and 12 week post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.

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