Coping BehaviorCADINCT02790892
Creative Arts Diabetes Initiative for Youth/Young Adults Transitioning to Adult Care
A study testing Art therapy - pre and post test measures in people with Coping Behavior and Emotional Distress, run by University of Manitoba at 1 site in Canada.
Trial summary
The Creative Arts Diabetes Initiative will offer facilitated art therapy with a group/peer-support environment to two groups of youth/young adults, one with type 1 diabetes, and one with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Coping Behavior, Emotional Distress, Diabetes Mellitus, Type 1
- What is being tested?
- Art therapy - pre and post test measures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to 21 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosed with either type 1 or type 2 diabetes, live within weekly travel distance to Winnipeg, Manitoba, receive their pediatric care at the Diabetes Education Resource for Children and Adolescents, or who are members of the Maestro Project
Who cannot join
- those who cannot give informed consent or who are not able to attend regular sessions due to travel distance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Creative Arts Diabetes Initiative: Group Art Therapy and Peer Support for Youth and Young Adults Transitioning From Pediatric to Adult Diabetes Care
The Creative Arts Diabetes Initiative will offer facilitated art therapy with a group/peer-support environment to two groups of youth/young adults, one with type 1 diabetes, and one with type 2 diabetes. This environment intends to "meet youth where they are", promote universality, hope and self-understanding, has the potential to be therapeutic and allows youth to express and learn about themselves and each other while developing healthy coping skills and address their fears and concerns.
Read the detailed description
The Creative Arts Diabetes Initiative will offer facilitated art therapy with a group/peer-support environment to two groups of youth/young adults, one with type 1 diabetes, and one with type 2 diabetes. This environment intends to "meet youth where they are", promote universality, hope and self-understanding, has the potential to be therapeutic and allows youth to express and learn about themselves and each other while developing healthy coping skills and address their fears and concerns.
As much of diabetes management is about meeting physical health goals - it is the vision of this study that offering additional support in the form of art therapy will have positive effects for bringing awareness and avenues for self-care to the other often neglected dimensions of patients' mental, emotional and spiritual health as part of a more holistic health process.
Engaging in art therapy has the potential to decrease diabetes related distress by giving youth a means and opportunity to identify, understand and express their feelings about having diabetes. Improved self-awareness and self-reflectiveness can help youth integrate their feelings and learn how this can motivate, influence and impact their behaviors and life choices.
Youth will have the opportunity for engaging in peer support, and to build relationships that are meaningful, thus increasing their sense of belonging and positively affect their level of self-confidence, purpose and wellbeing.
- Being tested
- Art therapy - pre and post test measures
- Keywords
- type 1 diabetes, type 2 diabetes, children, adolescents, young adults, youth, transition, art therapy, behavioral therapy
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art therapy - pre and post test measuresBehavioural
12 weeks of 90 minutes of art therapy with pre and post test measures to determine changes in social support and levels of diabetes distress
| Study group | Role | What they receive |
|---|---|---|
| Art therapy - pre and post test measures | Other | 20 young adults aged 15-24 years with diabetes (10 with type 1 diabetes and 10 with type 2 diabetes) receiving 12 weeks of group art therapy. Participants serve as their own controls. Receives: Behavioral: Art therapy - pre and post test measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease diabetes related distress
Decrease diabetes related distress as measured by the Diabetes Attitudes Wishes and Needs Study (DAWN) Problem Areas in Diabetes Questionnaire (PAID).
Measured: 12 weeks
Secondary outcomes (2)
Increase social support
Increase emotional and social support for youth as measured by Measures of Support (MOS) Social Support Survey.
Measured: 12 weeks
Increase emotional
Increase emotional and social support for youth as measured by Mental Health Continuum Short Form (MHC-SF)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startApr 2016
- Primary completion21 Jan 2019
- Study completion21 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coping BehaviorStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seth D Marks, MD,MSc,FRCPC, Principal investigator, University of Manitoba, Pediatric Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790892
- Sponsor's protocol ID
- HS19577 (H2016:119)
- Acronym
- CADI
- Status last verified
- Jan 2019
- First submitted
- 25 May 2016
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creative Arts Diabetes Initiative: Group Art Therapy and Peer Support for Youth and Young Adults Transitioning From Pediatric to Adult Diabetes Care
- ClinicalTrials.gov ID
- NCT02790892
- Acronym / sponsor ID
- CADI / HS19577 (H2016:119)
- Keywords
- type 1 diabetes, type 2 diabetes, children, adolescents, young adults, youth, transition, art therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 21 Jan 2019 (actual)
- Study completion
- 21 Jan 2019 (actual)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Creative Arts Diabetes Initiative will offer facilitated art therapy with a group/peer-support environment to two groups of youth/young adults, one with type 1 diabetes, and one with type 2 diabetes. This environment intends to "meet youth where they are", promote universality, hope and self-understanding, has the potential to be therapeutic and allows youth to express and learn about themselves and each other while developing healthy coping skills and address their fears and concerns.
Detailed description
The Creative Arts Diabetes Initiative will offer facilitated art therapy with a group/peer-support environment to two groups of youth/young adults, one with type 1 diabetes, and one with type 2 diabetes. This environment intends to "meet youth where they are", promote universality, hope and self-understanding, has the potential to be therapeutic and allows youth to express and learn about themselves and each other while developing healthy coping skills and address their fears and concerns.
As much of diabetes management is about meeting physical health goals - it is the vision of this study that offering additional support in the form of art therapy will have positive effects for bringing awareness and avenues for self-care to the other often neglected dimensions of patients' mental, emotional and spiritual health as part of a more holistic health process.
Engaging in art therapy has the potential to decrease diabetes related distress by giving youth a means and opportunity to identify, understand and express their feelings about having diabetes. Improved self-awareness and self-reflectiveness can help youth integrate their feelings and learn how this can motivate, influence and impact their behaviors and life choices.
Youth will have the opportunity for engaging in peer support, and to build relationships that are meaningful, thus increasing their sense of belonging and positively affect their level of self-confidence, purpose and wellbeing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Art therapy - pre and post test measures | Other | Behavioral: Art therapy - pre and post test measures20 young adults aged 15-24 years with diabetes (10 with type 1 diabetes and 10 with type 2 diabetes) receiving 12 weeks of group art therapy. Participants serve as their own controls. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- diagnosed with either type 1 or type 2 diabetes, live within weekly travel distance to Winnipeg, Manitoba, receive their pediatric care at the Diabetes Education Resource for Children and Adolescents, or who are members of the Maestro Project
Key exclusion criteria (1 listed)
- those who cannot give informed consent or who are not able to attend regular sessions due to travel distance
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 |
|---|---|---|
| Art therapy - pre and post test measures12 weeks of 90 minutes of art therapy with pre and post test measures to determine changes in social support and levels of diabetes distress | Behavioural | Art therapy - pre and post test measures |
Primary outcome
Decrease diabetes related distress
Time frame: 12 weeks
Decrease diabetes related distress as measured by the Diabetes Attitudes Wishes and Needs Study (DAWN) Problem Areas in Diabetes Questionnaire (PAID).
2 secondary outcomes
Increase social support
Time frame: 12 weeks
Increase emotional
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- young adult diabetes transition support serviceLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Seth D Marks, MD,MSc,FRCPC principal investigator
University of Manitoba, Pediatric Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art therapy - pre and post test measures in people with Coping Behavior and Emotional Distress, run by University of Manitoba 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 1 inclusion and 1 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 23 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Decrease diabetes related distress (time frame: 12 weeks). 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 23 Jan 2019.