Prevention of Self-care Deterioration in Early Adolescent... | NCT00890331

Studies
Prevention of Self-care Deterioration in Early Adolescents With Diabetes

NCT00890331

Sponsor

Virginia Commonwealth University

Status

Completed

Last Update Posted

Jan 8, 2016Estimated

Enrollment

285Actual

Phase

Phase 1

Conditions

Type 1 Diabetes

Interventions

TeamWork CS Sessions
Diabetes Education

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DK070917	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Apr 23, 2009

First Submission Date that Met QC Criteria

Apr 28, 2009

First Posted Date

Apr 29, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2016

Last Update Posted Date

Jan 8, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Virginia Commonwealth UniversityOTHER

Collaborators

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH
Children's National Research Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Establish the efficacy of a brief, clinic-based prevention program of teamwork coping skills for youth and their parents during in a high risk period of early adolescence (11-14 yrs) when parental involvement and self-care deterioration occurs.

Detailed Description

Promotion of optimal disease care and metabolic control in youth with Type 1 diabetes is an important goal of disease management during early adolescence. Typically youth assume increasing responsibility for these goals along with parental involvement and guidance. However, as youth progress through adolescence, parents often become less involved in diabetes management and poorer self-care and metabolic control often results.

The goal of the prevention program is to encourage parents to remain involved in their child's diabetes care throughout adolescence and to provide tools to help make that involvement a positive experience. To minimize parent/child conflict that may accompany sustained parental involvement, sessions of the active treatment review the following coping skills: communication, problem solving, conflict resolution, attitude and behavior change. Meetings occur in-clinic in conjunction with four consecutive medical appointments.

The educational comparison group also meets with study researchers for in-clinic sessions that occur in conjunction with four consecutive medical appointments. Families discuss a variety of helpful educational diabetes topics and resources.

The overarching project goal is to demonstrate the efficacy of a brief, prevention focused coping skills program for youth with type 1 diabetes and their parents with the ultimate goal of translation into routine pediatric care.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

285Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diabetes Education	Active Comparator		Behavioral: Diabetes Education
TeamWork CS Sessions	Experimental		Behavioral: TeamWork CS Sessions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TeamWork CS Sessions	Behavioral	The intervention focuses on an authoritative parenting approach that emphasizes continued parental involvement in daily disease care. Dyadic coping skills of communication, problem solving, conflict resolution, along with attitude and behavior change are highlighted. Families meet with a study interventionist in conjunction with four consecutive medical appointments.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Parental involvement and Disease care behaviors		Baseline, (optional 3, 6, and 9 months) 12, 15, 18 and 24 months

Secondary Outcomes

Measure	Description	Time Frame
Glycohemoglobin levels, Adverse effects and Blood glucose variability		Baseline, 3, 6, 9, 12, 15, 18, and 24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Seen for Diabetes care at Virginia Commonwealth University or Children's National Medical Center
Child ages 11-14
Type 1 Diabetes
Fluent in English
Ability to comprehend and complete questionnaires independently

Exclusion Criteria:

The presence of any other major disease
The presence of any severe diabetic complications which could impair test performance
Use of any medication that affects the CNS other than insulin
Inability to speak/comprehend and read English
Placement in special classes for the mentally disabled

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clarissa S Holmes, Ph.D.	Virginia Commonwealth University	Principal Investigator
Randi Streisand, Ph.D.	Children's National Research Institute	Principal Investigator
Rusan Chen, Ph.D.	Georgetown University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's National Medical Center		Washington D.C.	District of Columbia	20010	United States
Virginia Commonwealth University

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided