Diabetes Intervention Program for Adolescents With Persistent High HA1c

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Diabetes Intervention Program for Adolescents With Persistent High HA1c

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02212158
• Other study ID #: H2014:206
• Status: Not yet recruiting
• Phase: N/A
• First received: August 6, 2014
• Last updated: August 7, 2014
• Start date: September 2014
• Est. completion date: November 2015

Study information

• Verified date: August 2014
• Source: University of Manitoba
• Contact: Heather K MacKenzie, PhD
• Phone: 204-787-8963
• Email: hmackenzie3[@]hsc.mb.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

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.

Locations

Country	Name	City	State
Canada	Diabetes Resource for Children and Adolescence	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline HA1c at 6 months post baseline		Baseline, 6-months post baseline	No
Primary	Change from baseline HA1c at 3 months post baseline		Baseline, 3-months post baseline	No
Primary	Change from Baseline HA1c at 9 months post baseline		Baseline, 9-months post baseline	No
Primary	Change in Baseline HA1c at 12 months post baseline		Baseline, 12-months post baseline	No
Secondary	Change from baseline in Self-efficacy for Diabetes scale (SED) at 8 weeks		baseline, 8 weeks	No
Secondary	Change from baseline in Self-efficacy for Diabetes scale (SED) at 16 weeks		baseline, 16 weeks	No
Secondary	Change from baseline in Self-efficacy for Diabetes scale (SED) at 60 weeks		baseline, 60 weeks	No
Secondary	Change from baseline in Diabetes Family Behavior Scale at 8 weeks		baseline, 8 weeks	No
Secondary	Change from baseline in Diabetes Family Behavior Scale at 16 weeks		baseline, 16 weeks	No
Secondary	Change from baseline in Diabetes Family Behavior Scale at 60 weeks		baseline, 60 weeks	No
Secondary	Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 8 weeks		baseline, 8 weeks	No
Secondary	Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 16 weeks		baseline, 16 weeks	No
Secondary	Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 60 weeks		baseline, 60 weeks	No
Secondary	Change from baseline in Diabetes Quality of LIfe for Youth at 8 weeks		baseline, 8 weeks	No
Secondary	Change from baseline in Diabetes Quality of LIfe for Youth at 16 weeks		baseline, 16 weeks	No
Secondary	Change from baseline in Diabetes Quality of LIfe for Youth at 60 weeks		baseline, 60 weeks	No
Secondary	Change from baseline in Diabetes Management Questionnaire at 8 weeks		baseline, 8 weeks	No
Secondary	Change from baseline in Diabetes Management Questionnaire at 16 weeks		baseline, 16 weeks	No
Secondary	Change from baseline in Diabetes Management Questionnaire at 60 weeks		baseline, 60 weeks	No
Secondary	Change from baseline in Child Behavior Checklist (Parent form) at 8 weeks		baseline, 8 weeks	No
Secondary	Change from baseline in Child Behavior Checklist (Parent form) at 16 weeks		baseline, 16 weeks	No
Secondary	Change from baseline in Child Behavior Checklist (Parent form) at 60 weeks		baseline, 60 weeks	No
Secondary	Change from baseline in Low Blood Sugar Survey at 8 weeks		baseline, 8 weeks	No
Secondary	Change from baseline in Low Blood Sugar Survey at 16 weeks		baseline, 16 weeks	No
Secondary	Change from baseline in Low Blood Sugar Survey at 60 weeks		baseline, 60 weeks	No
Secondary	Change from baseline in Children's Hope Scale at 8 weeks		baseline, 8 weeks	No
Secondary	Change from baseline in Children's Hope Scale at 16 weeks		baseline, 16 weeks	No
Secondary	Change from baseline in Children's Hope Scale at 60 weeks		baseline, 60 weeks	No