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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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:
- 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?)
- 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
- 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)
- 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
- Conditions
- Intellectual Disability
- 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 group | Role | What they receive |
|---|---|---|
| DBT Group | Experimental | Adapted Dialectical Behaviour Therapy Receives: Behavioral: Adapted Dialectical Behaviour Therapy |
| Control Arm | No intervention | People 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.
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)
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
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
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
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.
- First posted29 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Dr. Jessica Jones
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Health & Services
- Responsible party
- Sponsor-investigator, Dr. Jessica Jones, Queen's University
- Investigators
- Jessica Jones, PhD, Principal investigator, Queen's University, Kingston
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting and Evaluating Dialectical Behaviour Group Therapy for Adults With Dual Diagnosis (Intellectual Disabilities With Psychiatric Disorder)
- ClinicalTrials.gov ID
- NCT02919826
- Acronym / sponsor ID
- PSIY-511-15
- Conditions
- Intellectual Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dr. Jessica JonesUniversity, hospital or other
- Collaborators
- Providence Health & Services
- Study start
- Aug 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Posted 22 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?)
- 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
- 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)
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBT Group | Experimental | Behavioral: Adapted Dialectical Behaviour TherapyAdapted Dialectical Behaviour Therapy |
| Control Arm | No intervention | –People in this group will receive treatment as usual |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Diagnosis of Autism Spectrum Disorder
- Profound or Severe Intellectual Disability
- Acute psychosis interfering with daily functioning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Dialectical Behaviour Therapy12 weekly sessions of DBT group therapy | Behavioural | DBT Group |
Primary outcome
Change in Difficulties in Emotional Regulation Scale (Gratz & Roemner, 2004)
Time frame: Pre treatment and 12 week post treatment
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).
4 secondary outcomes
Change in Novaco Anger Scale: Part B (Provocation Index)(Novaco, 2003)
Time frame: Pre treatment and 12 week post treatment
Change in Reiss Scale of Dual Diagnosis 38Q (IDS, 1987)
Time frame: Pre treatment and 12 week post treatment
Change in Adapted Emotion Regulation Checklist (Adapted With Permission From Dante Cicchetti by Jessica Jones)
Time frame: Pretreatment and 12 week post treatment
Global Impression of Change: Percentage of Participants Reporting Improvement
Time frame: 12 week Post Treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Jones, PhD principal investigator
Queen's University, Kingston
1 site in 1 country: see every site and its status.
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.