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Diabetes Intervention Program for Adolescents With Persistent High HA1c

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ClinicalTrials.gov Identifier: NCT02212158
Recruitment Status : Unknown
Verified August 2014 by Dr. Heather MacKenzie, University of Manitoba.
Recruitment status was:  Not yet recruiting
First Posted : August 8, 2014
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Heather MacKenzie, University of Manitoba

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Behavioral: motivational interviewing group Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diabetes Intervention Program for Adolescents With Persistent High HA1c
Study Start Date : September 2014
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: motivational interviewing group

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.

Behavioral: motivational interviewing group
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.




Primary Outcome Measures :
  1. Change from Baseline HA1c at 6 months post baseline [ Time Frame: Baseline, 6-months post baseline ]
  2. Change from baseline HA1c at 3 months post baseline [ Time Frame: Baseline, 3-months post baseline ]
  3. Change from Baseline HA1c at 9 months post baseline [ Time Frame: Baseline, 9-months post baseline ]
  4. Change in Baseline HA1c at 12 months post baseline [ Time Frame: Baseline, 12-months post baseline ]

Secondary Outcome Measures :
  1. Change from baseline in Self-efficacy for Diabetes scale (SED) at 8 weeks [ Time Frame: baseline, 8 weeks ]
  2. Change from baseline in Self-efficacy for Diabetes scale (SED) at 16 weeks [ Time Frame: baseline, 16 weeks ]
  3. Change from baseline in Self-efficacy for Diabetes scale (SED) at 60 weeks [ Time Frame: baseline, 60 weeks ]
  4. Change from baseline in Diabetes Family Behavior Scale at 8 weeks [ Time Frame: baseline, 8 weeks ]
  5. Change from baseline in Diabetes Family Behavior Scale at 16 weeks [ Time Frame: baseline, 16 weeks ]
  6. Change from baseline in Diabetes Family Behavior Scale at 60 weeks [ Time Frame: baseline, 60 weeks ]
  7. Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 8 weeks [ Time Frame: baseline, 8 weeks ]
  8. Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 16 weeks [ Time Frame: baseline, 16 weeks ]
  9. Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 60 weeks [ Time Frame: baseline, 60 weeks ]
  10. Change from baseline in Diabetes Quality of LIfe for Youth at 8 weeks [ Time Frame: baseline, 8 weeks ]
  11. Change from baseline in Diabetes Quality of LIfe for Youth at 16 weeks [ Time Frame: baseline, 16 weeks ]
  12. Change from baseline in Diabetes Quality of LIfe for Youth at 60 weeks [ Time Frame: baseline, 60 weeks ]
  13. Change from baseline in Diabetes Management Questionnaire at 8 weeks [ Time Frame: baseline, 8 weeks ]
  14. Change from baseline in Diabetes Management Questionnaire at 16 weeks [ Time Frame: baseline, 16 weeks ]
  15. Change from baseline in Diabetes Management Questionnaire at 60 weeks [ Time Frame: baseline, 60 weeks ]
  16. Change from baseline in Child Behavior Checklist (Parent form) at 8 weeks [ Time Frame: baseline, 8 weeks ]
  17. Change from baseline in Child Behavior Checklist (Parent form) at 16 weeks [ Time Frame: baseline, 16 weeks ]
  18. Change from baseline in Child Behavior Checklist (Parent form) at 60 weeks [ Time Frame: baseline, 60 weeks ]
  19. Change from baseline in Low Blood Sugar Survey at 8 weeks [ Time Frame: baseline, 8 weeks ]
  20. Change from baseline in Low Blood Sugar Survey at 16 weeks [ Time Frame: baseline, 16 weeks ]
  21. Change from baseline in Low Blood Sugar Survey at 60 weeks [ Time Frame: baseline, 60 weeks ]
  22. Change from baseline in Children's Hope Scale at 8 weeks [ Time Frame: baseline, 8 weeks ]
  23. Change from baseline in Children's Hope Scale at 16 weeks [ Time Frame: baseline, 16 weeks ]
  24. Change from baseline in Children's Hope Scale at 60 weeks [ Time Frame: baseline, 60 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212158


Contacts
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Contact: Heather K MacKenzie, PhD 204-787-8963 hmackenzie3@hsc.mb.ca
Contact: Jennifer Ducharme, PhD 204-787-7232 jlducharme@hsc.mb.ca

Locations
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Canada, Manitoba
Diabetes Resource for Children and Adolescence Not yet recruiting
Winnipeg, Manitoba, Canada, R3E 0Z9
Principal Investigator: Heather MacKenzie, PhD         
Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: Heather MacKenzie, PhD University of Manitoba

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Responsible Party: Dr. Heather MacKenzie, Ph.D., C. Psych. Candidate, University of Manitoba
ClinicalTrials.gov Identifier: NCT02212158     History of Changes
Other Study ID Numbers: H2014:206
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014
Keywords provided by Dr. Heather MacKenzie, University of Manitoba:
Type 1 diabetes
adolescents
HA1c
psychological intervention
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases