Diabetes Intervention Program for Adolescents With Persistent High HA1c

NCT02212158 | Unknown

• 1 other identifier: H2014:206
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Type 1 diabetes; adolescents; HA1c; psychological intervention

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (24)

• 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

Study Arms (1)

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.

Behavioral: motivational interviewing group

Interventions

motivational interviewing group BEHAVIORAL

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.

motivational interviewing group

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Diabetes Resource for Children and Adolescence

Winnipeg, Manitoba, R3E 0Z9, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Heather MacKenzie, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather K MacKenzie, PhD

CONTACT

204-787-8963; hmackenzie3@hsc.mb.ca

Jennifer Ducharme, PhD

CONTACT

204-787-7232; jlducharme@hsc.mb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., C. Psych. Candidate

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 8, 2014
• Study Start: September 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: November 1, 2015
• Last Updated: August 8, 2014

Record last verified: 2014-08

Locations

CA (1)