Skip to content

Dialectical Behaviour Group Therapy for Adults With Intellectual Disabilities

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02919826
Enrollment
20
Registered
2016-09-29
Start date
2016-08-31
Completion date
2018-03-31
Last updated
2020-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intellectual Disability

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

Interventions

BEHAVIORALAdapted Dialectical Behaviour Therapy

12 weekly sessions of DBT group therapy

Sponsors

Providence Health & Services
CollaboratorOTHER
Dr. Jessica Jones
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Difficulties in Emotional Regulation Scale (Gratz & Roemner, 2004)Pre treatment and 12 week post treatmentPsychometric 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

MeasureTime frameDescription
Change in Novaco Anger Scale: Part B (Provocation Index)(Novaco, 2003)Pre treatment and 12 week post treatmentPsychometric 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)Pre treatment and 12 week post treatmentPsychometric 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)Pretreatment and 12 week post treatmentPsychometric 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 Improvement12 week Post TreatmentAdapted 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.

Countries

Canada

Participant flow

Participants by arm

ArmCount
DBT Group
Adapted Dialectical Behaviour Therapy Adapted Dialectical Behaviour Therapy: 12 weekly sessions of DBT group therapy
10
Control Arm
People in this group will receive treatment as usual
10
Total20

Baseline characteristics

CharacteristicDBT GroupControl ArmTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
10 Participants10 Participants20 Participants
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
4 Participants8 Participants12 Participants
Sex: Female, Male
Male
6 Participants2 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 8
other
Total, other adverse events
0 / 100 / 8
serious
Total, serious adverse events
0 / 100 / 8

Outcome results

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).

Time frame: Pre treatment and 12 week post treatment

ArmMeasureValue (MEAN)Dispersion
DBT Group InterventionChange in Difficulties in Emotional Regulation Scale (Gratz & Roemner, 2004)1.4 score on a scaleStandard Deviation 18.5
Control ArmChange in Difficulties in Emotional Regulation Scale (Gratz & Roemner, 2004)0.8 score on a scaleStandard Deviation 13.2
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.

Time frame: Pretreatment and 12 week post treatment

ArmMeasureValue (MEAN)Dispersion
DBT Group InterventionChange in Adapted Emotion Regulation Checklist (Adapted With Permission From Dante Cicchetti by Jessica Jones)4.0 score on a scaleStandard Deviation 9.9
Control ArmChange in Adapted Emotion Regulation Checklist (Adapted With Permission From Dante Cicchetti by Jessica Jones)0.5 score on a scaleStandard Deviation 7.4
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).

Time frame: Pre treatment and 12 week post treatment

ArmMeasureValue (MEAN)Dispersion
DBT Group InterventionChange in Novaco Anger Scale: Part B (Provocation Index)(Novaco, 2003)6.4 score on a scaleStandard Deviation 15.6
Control ArmChange in Novaco Anger Scale: Part B (Provocation Index)(Novaco, 2003)5.6 score on a scaleStandard Deviation 11.7
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.)

Time frame: Pre treatment and 12 week post treatment

ArmMeasureValue (MEAN)Dispersion
DBT Group InterventionChange in Reiss Scale of Dual Diagnosis 38Q (IDS, 1987)1.8 score on a scaleStandard Deviation 9.3
Control ArmChange in Reiss Scale of Dual Diagnosis 38Q (IDS, 1987)2.9 score on a scaleStandard Deviation 5.5
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.

Time frame: 12 week Post Treatment

Population: Following team review participants included in intervention group also belonged to control group. Institutional review board required treatment be offered to control group at end of study. Post-treatment data was collected for all participants who participated in the intervention using this measure. There was missing data (2) for treatment arm.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DBT Group InterventionGlobal Impression of Change: Percentage of Participants Reporting Improvement12 Participants
Control ArmGlobal Impression of Change: Percentage of Participants Reporting Improvement0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026