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TEENCOPE: An Internet Coping Skills Training Program for Teens With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
TeenCope
Managing Diabetes
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Children and Teenagers, Coping with Chronic Illness, Adolescence, Internet psychosocial program, Coping Skills Training

Eligibility Criteria

11 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 11-14
  • English speaking
  • Youth assents and parent consents to participation
  • School grade is appropriate to age within 1 year
  • Type 1 diabetes for a minimum of 6 months
  • Access to high speed internet service for 5 week intervention (will be arranged by study if not presently in the home)

Exclusion Criteria:

  • Other significant chronic health problems requiring intensive self-management
  • Previous exposure to Yale School of Nursing's Coping Skills Training or Managing Diabetes materials

Sites / Locations

  • University of Arizona
  • Yale University School of Nursing
  • University of Miami
  • Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

TeenCope: Internet-based Coping Skills Training

Managing Diabetes: Internet-based Diabetes Education

Outcomes

Primary Outcome Measures

Hemoglobin A1c (HbA1c)
Pediatric Quality of Life Inventory (PedsQL)

Secondary Outcome Measures

Perceived Stress Scale (PSS)
Self-Efficacy for Diabetes Scale
Children's Depression Inventory
Self-Perception Profile for Adolescents
Responses to Stress Questionaire (RSQ)
Diabetes Family Behavior Scale
Self Management of Type 1 Diabetes
Diabetes Conflict

Full Information

First Posted
May 21, 2008
Last Updated
March 31, 2020
Sponsor
Yale University
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT00684658
Brief Title
TEENCOPE: An Internet Coping Skills Training Program for Teens With Type 1 Diabetes
Official Title
An Internet Coping Skills Training Program for Teens With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to compare the effects of a 5-week internet-based coping skills training program (TeenCope) with a 5-week internet education program (Managing Diabetes) in youth (age 11-14) with type 1 diabetes on intensive insulin therapy.
Detailed Description
It is well established that for many youth with type 1 diabetes (T1D), the developmental stage of puberty is characterized by a significant deterioration in metabolic control. Previous research conducted by the Yale School of Nursing demonstrates that providing cognitive-behavioral coping skills training program (CST) as a supplement to intensive medical treatment regimen enhances physiological and psychosocial outcomes - most notably in youth as they approach adolescence. Successful CST programs studied at Yale consist of weekly, in-person group sessions over a 5-week period conducted by a clinical psychologist or social worker. Rapid advances in technology have made the internet a compelling tool to reach out to youth and significantly broaden the application of CST programs. Investigators at Yale (scientists, NPs, clinical psychologists) have teamed with web specialists (computer programmers, web designers, graphic artists, and illustrators) and youth with T1D and their parents to adapt the successful CST program for use on the internet. In this trial, internet-based CST (TeenCope) will be evaluated by comparing it to an internet-based education program for managing diabetes (Managing Diabetes). Three hundred (300) youth from 4 different sites within the U.S will take part in the study. Youth will be randomly assigned to complete either the TeenCope or Managing Diabetes program right away, and will be given the opportunity to complete the alternate program after 12 months. Data on psychosocial and disease management parameters will be collected at baseline, 3, 6, 12 and 18 months through youth filling out online questionnaires (lasting approximately 30 minutes). Clinical outcome data (height, weight, HbA1c, episodes of hypoglycemia, DKA, and hospitalization) will be collected from the medical chart throughout the study, and parents will complete a demographic data form. This study has great potential for working with youth with type 1 diabetes. If proven effective, the investigators are interested in continued dissemination and translation of this intervention beyond their geographical location.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 Diabetes, Children and Teenagers, Coping with Chronic Illness, Adolescence, Internet psychosocial program, Coping Skills Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
TeenCope: Internet-based Coping Skills Training
Arm Title
2
Arm Type
Active Comparator
Arm Description
Managing Diabetes: Internet-based Diabetes Education
Intervention Type
Behavioral
Intervention Name(s)
TeenCope
Intervention Description
Teencope consists of a series of 5 sessions designed to increase children's sense of competence and mastery by retraining inappropriate or non-constructive coping styles and forming more positive styles and patterns of behavior. Each week a new 30-45 minute session is uploaded to a password-protected website on the Yale server for youth to complete. Youth are grouped with 8-12 peers who complete the same weekly sessions in an asynchronous manner. Youth interact with each other on an online discussion board moderated by a clinical psychologist
Intervention Type
Behavioral
Intervention Name(s)
Managing Diabetes
Intervention Description
Managing Diabetes consists of 5 sessions on educational content related to diabetes self management targeted to adolescents. As with the TeenCope program, each week a new 30-45 minute session is uploaded to a password-protected website on the Yale server for youth to complete. Youth complete educational sessions independently over 5 weeks. There is no online discussion board or peer interaction.
Primary Outcome Measure Information:
Title
Hemoglobin A1c (HbA1c)
Time Frame
18 months
Title
Pediatric Quality of Life Inventory (PedsQL)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Perceived Stress Scale (PSS)
Time Frame
18 months
Title
Self-Efficacy for Diabetes Scale
Time Frame
18 months
Title
Children's Depression Inventory
Time Frame
18 months
Title
Self-Perception Profile for Adolescents
Time Frame
18 months
Title
Responses to Stress Questionaire (RSQ)
Time Frame
18 months
Title
Diabetes Family Behavior Scale
Time Frame
18 months
Title
Self Management of Type 1 Diabetes
Time Frame
18 months
Title
Diabetes Conflict
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 11-14 English speaking Youth assents and parent consents to participation School grade is appropriate to age within 1 year Type 1 diabetes for a minimum of 6 months Access to high speed internet service for 5 week intervention (will be arranged by study if not presently in the home) Exclusion Criteria: Other significant chronic health problems requiring intensive self-management Previous exposure to Yale School of Nursing's Coping Skills Training or Managing Diabetes materials
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Grey, DrPh, FAAN, CPNP
Organizational Affiliation
Yale School of Nursing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robin Whittemore, PhD, APRN
Organizational Affiliation
Yale School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States
Facility Name
Yale University School of Nursing
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10891831
Citation
Grey M, Boland EA, Davidson M, Li J, Tamborlane WV. Coping skills training for youth with diabetes mellitus has long-lasting effects on metabolic control and quality of life. J Pediatr. 2000 Jul;137(1):107-13. doi: 10.1067/mpd.2000.106568.
Results Reference
background
PubMed Identifier
9614605
Citation
Grey M, Boland EA, Davidson M, Yu C, Sullivan-Bolyai S, Tamborlane WV. Short-term effects of coping skills training as adjunct to intensive therapy in adolescents. Diabetes Care. 1998 Jun;21(6):902-8. doi: 10.2337/diacare.21.6.902.
Results Reference
background
PubMed Identifier
20182161
Citation
Whittemore R, Grey M, Lindemann E, Ambrosino J, Jaser S. Development of an Internet coping skills training program for teenagers with type 1 diabetes. Comput Inform Nurs. 2010 Mar-Apr;28(2):103-11. doi: 10.1097/NCN.0b013e3181cd8199.
Results Reference
background
PubMed Identifier
22484337
Citation
Grey M, Whittemore R, Liberti L, Delamater A, Murphy K, Faulkner MS. A comparison of two internet programs for adolescents with type 1 diabetes: design and methods. Contemp Clin Trials. 2012 Jul;33(4):769-76. doi: 10.1016/j.cct.2012.03.012. Epub 2012 Mar 29.
Results Reference
background
PubMed Identifier
24163439
Citation
Jaser SS, Whittemore R, Chao A, Jeon S, Faulkner MS, Grey M. Mediators of 12-month outcomes of two Internet interventions for youth with type 1 diabetes. J Pediatr Psychol. 2014 Apr;39(3):306-15. doi: 10.1093/jpepsy/jst081. Epub 2013 Oct 26.
Results Reference
derived
PubMed Identifier
23579179
Citation
Grey M, Whittemore R, Jeon S, Murphy K, Faulkner MS, Delamater A; TeenCope Study Group. Internet psycho-education programs improve outcomes in youth with type 1 diabetes. Diabetes Care. 2013 Sep;36(9):2475-82. doi: 10.2337/dc12-2199. Epub 2013 Apr 11.
Results Reference
derived
PubMed Identifier
22960587
Citation
Whittemore R, Jaser SS, Jeon S, Liberti L, Delamater A, Murphy K, Faulkner MS, Grey M. An internet coping skills training program for youth with type 1 diabetes: six-month outcomes. Nurs Res. 2012 Nov-Dec;61(6):395-404. doi: 10.1097/NNR.0b013e3182690a29.
Results Reference
derived
PubMed Identifier
22274724
Citation
Jaser SS, Faulkner MS, Whittemore R, Jeon S, Murphy K, Delamater A, Grey M. Coping, self-management, and adaptation in adolescents with type 1 diabetes. Ann Behav Med. 2012 Jun;43(3):311-9. doi: 10.1007/s12160-012-9343-z.
Results Reference
derived

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TEENCOPE: An Internet Coping Skills Training Program for Teens With Type 1 Diabetes

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