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Diabetes Intervention Program for Adolescents With Persistent High HA1c

Primary Purpose

Diabetes Mellitus, Type 1

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
motivational interviewing group
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Type 1 diabetes, adolescents, HA1c, psychological intervention

Eligibility Criteria

13 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Diabetes Resource for Children and Adolescence

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

motivational interviewing group

Arm Description

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.

Outcomes

Primary Outcome Measures

Change from Baseline HA1c at 6 months post baseline
Change from baseline HA1c at 3 months post baseline
Change from Baseline HA1c at 9 months post baseline
Change in Baseline HA1c at 12 months post baseline

Secondary Outcome Measures

Change from baseline in Self-efficacy for Diabetes scale (SED) at 8 weeks
Change from baseline in Self-efficacy for Diabetes scale (SED) at 16 weeks
Change from baseline in Self-efficacy for Diabetes scale (SED) at 60 weeks
Change from baseline in Diabetes Family Behavior Scale at 8 weeks
Change from baseline in Diabetes Family Behavior Scale at 16 weeks
Change from baseline in Diabetes Family Behavior Scale at 60 weeks
Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 8 weeks
Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 16 weeks
Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 60 weeks
Change from baseline in Diabetes Quality of LIfe for Youth at 8 weeks
Change from baseline in Diabetes Quality of LIfe for Youth at 16 weeks
Change from baseline in Diabetes Quality of LIfe for Youth at 60 weeks
Change from baseline in Diabetes Management Questionnaire at 8 weeks
Change from baseline in Diabetes Management Questionnaire at 16 weeks
Change from baseline in Diabetes Management Questionnaire at 60 weeks
Change from baseline in Child Behavior Checklist (Parent form) at 8 weeks
Change from baseline in Child Behavior Checklist (Parent form) at 16 weeks
Change from baseline in Child Behavior Checklist (Parent form) at 60 weeks
Change from baseline in Low Blood Sugar Survey at 8 weeks
Change from baseline in Low Blood Sugar Survey at 16 weeks
Change from baseline in Low Blood Sugar Survey at 60 weeks
Change from baseline in Children's Hope Scale at 8 weeks
Change from baseline in Children's Hope Scale at 16 weeks
Change from baseline in Children's Hope Scale at 60 weeks

Full Information

First Posted
August 6, 2014
Last Updated
August 7, 2014
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT02212158
Brief Title
Diabetes Intervention Program for Adolescents With Persistent High HA1c
Official Title
Diabetes Intervention Program for Adolescents With Persistent High HA1c
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Type 1 diabetes, adolescents, HA1c, psychological intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
motivational interviewing group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
motivational interviewing group
Intervention Description
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 Measure Information:
Title
Change from Baseline HA1c at 6 months post baseline
Time Frame
Baseline, 6-months post baseline
Title
Change from baseline HA1c at 3 months post baseline
Time Frame
Baseline, 3-months post baseline
Title
Change from Baseline HA1c at 9 months post baseline
Time Frame
Baseline, 9-months post baseline
Title
Change in Baseline HA1c at 12 months post baseline
Time Frame
Baseline, 12-months post baseline
Secondary Outcome Measure Information:
Title
Change from baseline in Self-efficacy for Diabetes scale (SED) at 8 weeks
Time Frame
baseline, 8 weeks
Title
Change from baseline in Self-efficacy for Diabetes scale (SED) at 16 weeks
Time Frame
baseline, 16 weeks
Title
Change from baseline in Self-efficacy for Diabetes scale (SED) at 60 weeks
Time Frame
baseline, 60 weeks
Title
Change from baseline in Diabetes Family Behavior Scale at 8 weeks
Time Frame
baseline, 8 weeks
Title
Change from baseline in Diabetes Family Behavior Scale at 16 weeks
Time Frame
baseline, 16 weeks
Title
Change from baseline in Diabetes Family Behavior Scale at 60 weeks
Time Frame
baseline, 60 weeks
Title
Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 8 weeks
Time Frame
baseline, 8 weeks
Title
Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 16 weeks
Time Frame
baseline, 16 weeks
Title
Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 60 weeks
Time Frame
baseline, 60 weeks
Title
Change from baseline in Diabetes Quality of LIfe for Youth at 8 weeks
Time Frame
baseline, 8 weeks
Title
Change from baseline in Diabetes Quality of LIfe for Youth at 16 weeks
Time Frame
baseline, 16 weeks
Title
Change from baseline in Diabetes Quality of LIfe for Youth at 60 weeks
Time Frame
baseline, 60 weeks
Title
Change from baseline in Diabetes Management Questionnaire at 8 weeks
Time Frame
baseline, 8 weeks
Title
Change from baseline in Diabetes Management Questionnaire at 16 weeks
Time Frame
baseline, 16 weeks
Title
Change from baseline in Diabetes Management Questionnaire at 60 weeks
Time Frame
baseline, 60 weeks
Title
Change from baseline in Child Behavior Checklist (Parent form) at 8 weeks
Time Frame
baseline, 8 weeks
Title
Change from baseline in Child Behavior Checklist (Parent form) at 16 weeks
Time Frame
baseline, 16 weeks
Title
Change from baseline in Child Behavior Checklist (Parent form) at 60 weeks
Time Frame
baseline, 60 weeks
Title
Change from baseline in Low Blood Sugar Survey at 8 weeks
Time Frame
baseline, 8 weeks
Title
Change from baseline in Low Blood Sugar Survey at 16 weeks
Time Frame
baseline, 16 weeks
Title
Change from baseline in Low Blood Sugar Survey at 60 weeks
Time Frame
baseline, 60 weeks
Title
Change from baseline in Children's Hope Scale at 8 weeks
Time Frame
baseline, 8 weeks
Title
Change from baseline in Children's Hope Scale at 16 weeks
Time Frame
baseline, 16 weeks
Title
Change from baseline in Children's Hope Scale at 60 weeks
Time Frame
baseline, 60 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather K MacKenzie, PhD
Phone
204-787-8963
Email
hmackenzie3@hsc.mb.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Ducharme, PhD
Phone
204-787-7232
Email
jlducharme@hsc.mb.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather MacKenzie, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetes Resource for Children and Adolescence
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0Z9
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather MacKenzie, PhD

12. IPD Sharing Statement

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Diabetes Intervention Program for Adolescents With Persistent High HA1c

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