Diabetes Intervention Program for Adolescents With Persistent High HA1c

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Type 1 Diabetes, Exercise and Mentoring Trial

NCT06296992

Type 1 Diabetes Physical Activity

RECRUITING NA

High Risk Youth With Poorly-controlled Diabetes

NCT03680079

Type 1 Diabetes Mellitus

COMPLETED NA

Home-Based Interventions for Adolescents With Type 1 Diabetes

NCT02243072

Type 1 Diabetes

COMPLETED NA

Motivational Interview in Adolescents With Poorly Controlled Type 1 Diabetes

NCT02637154

Diabetes Mellitus, Type 1

UNKNOWN NA

Self Efficacy Levels, Attachment Style and Resiliency of Youth With Type 1 Diabetes

NCT04172077

Type1diabetes

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

motivational interviewing group

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes