Diabetes Mellitus, Type 1NCT02212158
Diabetes Intervention Program for Adolescents With Persistent High HA1c
A study testing motivational interviewing group in people with Diabetes Mellitus, Type 1, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of this project is to assess the feasibility and efficacy of a new group therapy program for adolescents with Type 1 diabetes and compromised metabolic control (high A1c). Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- motivational interviewing group
- 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
- Sep 2014to Nov 2015
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The therapy group will be composed of teens that currently have a documented history of elevated HA1c's that have persisted for at least 3 months
- Potential candidates for the group will be recruited from all the physician's caseloads in the clinic.
Who cannot join
- Patients with Type II diabetes
- Those who are medically unstable due to other medical conditions
- Those who refuse to participate will not be included in the study
Trial locations and contacts
1 site in 1 country.
Canada1 site
Diabetes Resource for Children and Adolescence
Winnipeg, Manitoba, R3E 0Z9
Heather MacKenzie, PhD
About this study
The purpose of this project is to assess the feasibility and efficacy of a new group therapy program for adolescents with Type 1 diabetes and compromised metabolic control (high A1c). This intervention is aimed at addressing issues frequently found to be associated with poor control: knowledge deficits, parental supervision, parent-teen communication and psychosocial barriers. In order to test this new group therapy program, adolescents' HA1c and psychosocial functioning will be monitored pre- and post-intervention. It is hypothesized that individuals who participate in the group therapy program will show an improvement in their HA1c levels and quality of life, self-efficacy, supportive behaviors from family members, readiness to make improvements in their diabetes care and decrease symptoms of depression.
Read the detailed description
Basic Design:
This study will pilot a group therapy intervention for adolescents seen in the diabetes clinic who have had elevated HA1c's for at least 3 months. This group will be offered in fall of 2014. Group therapy sessions will include 8 teen sessions that cover the following topics: acceptance of diabetes, family issues, division of diabetes management, communication and facilitating motivation and skill development to improve diabetes care. Motivational interviewing and cognitive behavioral techniques will be the therapeutic modalities used in sessions. Parents will be involved in 3 therapy sessions that cover topics regarding family functioning, division of responsibility and parenting strategies. Participants will complete questionnaires measuring self-efficacy, family support, quality of life, readiness to change and symptoms of depression. Questionnaires will be administered at an initial assessment prior to participation in the group, at completion of the 8 week program, at a follow-up visit 2 months following the completion of the group and 1 year post-intervention. Questionnaires will take approximately 45 minutes to complete. HA1c levels will be evaluated for participants every 3 months as per regular clinic care. This intervention program will be offered to teens upon an elevated HA1c result.
Primary Outcomes:
HA1c levels will be tested every three months as per regular clinic care. Basic demographic information will be obtained from participants during the initial assessment for the group (age, family size, and date of diagnosis of diabetes).
Secondary Outcomes:
Psychosocial functioning will be evaluated pre- and post-intervention by having participants and their parents fill out the following questionnaires: Self-efficacy for Diabetes Scale (SED); Diabetes Quality of Life for Youths; Diabetes Family Behavior Scale; Beck Depression Inventory for Youth (BDI-Y); Diabetes Management Questionnaire; Child Behavior Checklist (Parent form); Low Blood Sugar Survey, and Children's Hope Scale.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- motivational interviewing group
- Keywords
- Type 1 diabetes, adolescents, HA1c, psychological intervention
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational interviewing groupBehavioural
Group therapy sessions will include 8 teen sessions that cover the following topics: acceptance of diabetes, family issues, division of diabetes management, communication and facilitating motivation and skill development to improve diabetes care. Motivational interviewing and cognitive behavioral techniques will be the therapeutic modalities used in sessions. Parents will be involved in 3 therapy sessions that cover topics regarding family functioning, division of responsibility and parenting strategies.
| Study group | Role | What they receive |
|---|---|---|
| motivational interviewing group | Experimental | Motivational Group Intervention:
Group therapy sessions will include 8 teen sessions that cover the following topics: acceptance of diabetes, family issues, division of diabetes management, communication and facilitating motivation and skill development to improve diabetes care. Motivational interviewing and cognitive behavioral techniques will be the therapeutic modalities used in sessions. Parents will be involved in 3 therapy sessions that cover topics regarding family functioning, division of responsibility and parenting strategies. Receives: Behavioral: motivational interviewing group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline HA1c at 6 months post baseline
Measured: Baseline, 6-months post baseline
Change from baseline HA1c at 3 months post baseline
Measured: Baseline, 3-months post baseline
Change from Baseline HA1c at 9 months post baseline
Measured: Baseline, 9-months post baseline
Change in Baseline HA1c at 12 months post baseline
Measured: Baseline, 12-months post baseline
Secondary outcomes (24)
Change from baseline in Self-efficacy for Diabetes scale (SED) at 8 weeks
Measured: baseline, 8 weeks
Change from baseline in Self-efficacy for Diabetes scale (SED) at 16 weeks
Measured: baseline, 16 weeks
Change from baseline in Self-efficacy for Diabetes scale (SED) at 60 weeks
Measured: baseline, 60 weeks
Change from baseline in Diabetes Family Behavior Scale at 8 weeks
Measured: baseline, 8 weeks
Change from baseline in Diabetes Family Behavior Scale at 16 weeks
Measured: baseline, 16 weeks
Change from baseline in Diabetes Family Behavior Scale at 60 weeks
Measured: baseline, 60 weeks
Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 8 weeks
Measured: baseline, 8 weeks
Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 16 weeks
Measured: baseline, 16 weeks
Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 60 weeks
Measured: baseline, 60 weeks
Change from baseline in Diabetes Quality of LIfe for Youth at 8 weeks
Measured: baseline, 8 weeks
Change from baseline in Diabetes Quality of LIfe for Youth at 16 weeks
Measured: baseline, 16 weeks
Change from baseline in Diabetes Quality of LIfe for Youth at 60 weeks
Measured: baseline, 60 weeks
Change from baseline in Diabetes Management Questionnaire at 8 weeks
Measured: baseline, 8 weeks
Change from baseline in Diabetes Management Questionnaire at 16 weeks
Measured: baseline, 16 weeks
Change from baseline in Diabetes Management Questionnaire at 60 weeks
Measured: baseline, 60 weeks
Change from baseline in Child Behavior Checklist (Parent form) at 8 weeks
Measured: baseline, 8 weeks
Change from baseline in Child Behavior Checklist (Parent form) at 16 weeks
Measured: baseline, 16 weeks
Change from baseline in Child Behavior Checklist (Parent form) at 60 weeks
Measured: baseline, 60 weeks
Change from baseline in Low Blood Sugar Survey at 8 weeks
Measured: baseline, 8 weeks
Change from baseline in Low Blood Sugar Survey at 16 weeks
Measured: baseline, 16 weeks
Change from baseline in Low Blood Sugar Survey at 60 weeks
Measured: baseline, 60 weeks
Change from baseline in Children's Hope Scale at 8 weeks
Measured: baseline, 8 weeks
Change from baseline in Children's Hope Scale at 16 weeks
Measured: baseline, 16 weeks
Change from baseline in Children's Hope Scale at 60 weeks
Measured: baseline, 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Heather MacKenzie, University of Manitoba
- Investigators
- Heather MacKenzie, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212158
- Sponsor's protocol ID
- H2014:206
- Status last verified
- Aug 2014
- First submitted
- 6 Aug 2014
- Last updated
- 8 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Intervention Program for Adolescents With Persistent High HA1c
- ClinicalTrials.gov ID
- NCT02212158
- Acronym / sponsor ID
- H2014:206
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 diabetes, adolescents, HA1c, psychological intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 8 Aug 2014 (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 purpose of this project is to assess the feasibility and efficacy of a new group therapy program for adolescents with Type 1 diabetes and compromised metabolic control (high A1c). This intervention is aimed at addressing issues frequently found to be associated with poor control: knowledge deficits, parental supervision, parent-teen communication and psychosocial barriers. In order to test this new group therapy program, adolescents' HA1c and psychosocial functioning will be monitored pre- and post-intervention. It is hypothesized that individuals who participate in the group therapy program will show an improvement in their HA1c levels and quality of life, self-efficacy, supportive behaviors from family members, readiness to make improvements in their diabetes care and decrease symptoms of depression.
Detailed description
Basic Design:
This study will pilot a group therapy intervention for adolescents seen in the diabetes clinic who have had elevated HA1c's for at least 3 months. This group will be offered in fall of 2014. Group therapy sessions will include 8 teen sessions that cover the following topics: acceptance of diabetes, family issues, division of diabetes management, communication and facilitating motivation and skill development to improve diabetes care. Motivational interviewing and cognitive behavioral techniques will be the therapeutic modalities used in sessions. Parents will be involved in 3 therapy sessions that cover topics regarding family functioning, division of responsibility and parenting strategies. Participants will complete questionnaires measuring self-efficacy, family support, quality of life, readiness to change and symptoms of depression. Questionnaires will be administered at an initial assessment prior to participation in the group, at completion of the 8 week program, at a follow-up visit 2 months following the completion of the group and 1 year post-intervention. Questionnaires will take approximately 45 minutes to complete. HA1c levels will be evaluated for participants every 3 months as per regular clinic care. This intervention program will be offered to teens upon an elevated HA1c result.
Primary Outcomes:
HA1c levels will be tested every three months as per regular clinic care. Basic demographic information will be obtained from participants during the initial assessment for the group (age, family size, and date of diagnosis of diabetes).
Secondary Outcomes:
Psychosocial functioning will be evaluated pre- and post-intervention by having participants and their parents fill out the following questionnaires: Self-efficacy for Diabetes Scale (SED); Diabetes Quality of Life for Youths; Diabetes Family Behavior Scale; Beck Depression Inventory for Youth (BDI-Y); Diabetes Management Questionnaire; Child Behavior Checklist (Parent form); Low Blood Sugar Survey, and Children's Hope Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| motivational interviewing group | Experimental | Behavioral: motivational interviewing groupMotivational Group Intervention: Group therapy sessions will include 8 teen sessions that cover the following topics: acceptance of diabetes, family issues, division of diabetes management, communication and facilitating motivation and skill development to improve diabetes care. Motivational interviewing and cognitive behavioral techniques will be the therapeutic modalities used in sessions. Parents will be involved in 3 therapy sessions that cover topics regarding family functioning, division of responsibility and parenting strategies. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- The therapy group will be composed of teens that currently have a documented history of elevated HA1c's that have persisted for at least 3 months
- Potential candidates for the group will be recruited from all the physician's caseloads in the clinic.
Key exclusion criteria (3 listed)
- Patients with Type II diabetes
- Those who are medically unstable due to other medical conditions
- Those who refuse to participate will not be included in the study
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 |
|---|---|---|
| motivational interviewing groupGroup therapy sessions will include 8 teen sessions that cover the following topics: acceptance of diabetes, family issues, division of diabetes management, communication and facilitating motivation and skill development to improve diabetes care. Motivational interviewing and cognitive behavioral techniques will be the therapeutic modalities used in sessions. Parents will be involved in 3 therapy sessions that cover topics regarding family functioning, division of responsibility and parenting strategies. | Behavioural | motivational interviewing group |
Primary outcome
Change from Baseline HA1c at 6 months post baseline
Time frame: Baseline, 6-months post baseline
Change from baseline HA1c at 3 months post baseline
Time frame: Baseline, 3-months post baseline
Change from Baseline HA1c at 9 months post baseline
Time frame: Baseline, 9-months post baseline
Change in Baseline HA1c at 12 months post baseline
Time frame: Baseline, 12-months post baseline
24 secondary outcomes
Change from baseline in Self-efficacy for Diabetes scale (SED) at 8 weeks
Time frame: baseline, 8 weeks
Change from baseline in Self-efficacy for Diabetes scale (SED) at 16 weeks
Time frame: baseline, 16 weeks
Change from baseline in Self-efficacy for Diabetes scale (SED) at 60 weeks
Time frame: baseline, 60 weeks
Change from baseline in Diabetes Family Behavior Scale at 8 weeks
Time frame: baseline, 8 weeks
Change from baseline in Diabetes Family Behavior Scale at 16 weeks
Time frame: baseline, 16 weeks
Change from baseline in Diabetes Family Behavior Scale at 60 weeks
Time frame: baseline, 60 weeks
Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 8 weeks
Time frame: baseline, 8 weeks
Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 16 weeks
Time frame: baseline, 16 weeks
Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 60 weeks
Time frame: baseline, 60 weeks
Change from baseline in Diabetes Quality of LIfe for Youth at 8 weeks
Time frame: baseline, 8 weeks
Change from baseline in Diabetes Quality of LIfe for Youth at 16 weeks
Time frame: baseline, 16 weeks
Change from baseline in Diabetes Quality of LIfe for Youth at 60 weeks
Time frame: baseline, 60 weeks
Change from baseline in Diabetes Management Questionnaire at 8 weeks
Time frame: baseline, 8 weeks
Change from baseline in Diabetes Management Questionnaire at 16 weeks
Time frame: baseline, 16 weeks
Change from baseline in Diabetes Management Questionnaire at 60 weeks
Time frame: baseline, 60 weeks
Change from baseline in Child Behavior Checklist (Parent form) at 8 weeks
Time frame: baseline, 8 weeks
Change from baseline in Child Behavior Checklist (Parent form) at 16 weeks
Time frame: baseline, 16 weeks
Change from baseline in Child Behavior Checklist (Parent form) at 60 weeks
Time frame: baseline, 60 weeks
Change from baseline in Low Blood Sugar Survey at 8 weeks
Time frame: baseline, 8 weeks
Change from baseline in Low Blood Sugar Survey at 16 weeks
Time frame: baseline, 16 weeks
Change from baseline in Low Blood Sugar Survey at 60 weeks
Time frame: baseline, 60 weeks
Change from baseline in Children's Hope Scale at 8 weeks
Time frame: baseline, 8 weeks
Change from baseline in Children's Hope Scale at 16 weeks
Time frame: baseline, 16 weeks
Change from baseline in Children's Hope Scale at 60 weeks
Time frame: baseline, 60 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2014.
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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.
Heather MacKenzie, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motivational interviewing group in people with Diabetes Mellitus, Type 1, 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 2 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: status not confirmed, as of the sponsor's last update on 8 Aug 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heather K MacKenzie, PhD (204-787-8963, hmackenzie3@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline HA1c at 6 months post baseline (time frame: Baseline, 6-months post baseline). The study lists 4 primary outcomes in all. 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 8 Aug 2014.