Diabetes Intervention Program for Adolescents With Persistent High HA1c

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Behavioral: motivational interviewing group

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0Z9
      • Diabetes Resource for Children and Adolescence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline HA1c at 6 months post baseline	Baseline, 6-months post baseline
Change from baseline HA1c at 3 months post baseline	Baseline, 3-months post baseline
Change from Baseline HA1c at 9 months post baseline	Baseline, 9-months post baseline
Change in Baseline HA1c at 12 months post baseline	Baseline, 12-months post baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Heather MacKenzie, PhD, University of Manitoba

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): April 1, 2015
• Study Completion (Anticipated): November 1, 2015

Study Registration Dates

• First Submitted: August 6, 2014
• First Submitted That Met QC Criteria: August 7, 2014
• First Posted (Estimate): August 8, 2014

Study Record Updates

• Last Update Posted (Estimate): August 8, 2014
• Last Update Submitted That Met QC Criteria: August 7, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: adolescents; Type 1 diabetes; psychological intervention; HA1c
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: H2014:206