NCT00684658

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2008

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2020

Enrollment Period

4 years

First QC Date

May 21, 2008

Last Update Submit

March 31, 2020

Conditions

Type 1 Diabetes

Keywords

Type 1 DiabetesChildren and TeenagersCoping with Chronic IllnessAdolescenceInternet psychosocial programCoping Skills Training

Outcome Measures

Primary Outcomes (2)

  • Hemoglobin A1c (HbA1c)

    18 months

  • Pediatric Quality of Life Inventory (PedsQL)

    18 months

Secondary Outcomes (8)

  • Perceived Stress Scale (PSS)

    18 months

  • Self-Efficacy for Diabetes Scale

    18 months

  • Children's Depression Inventory

    18 months

  • Self-Perception Profile for Adolescents

    18 months

  • Responses to Stress Questionaire (RSQ)

    18 months

  • +3 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

TeenCope: Internet-based Coping Skills Training

Behavioral: TeenCope

2

ACTIVE COMPARATOR

Managing Diabetes: Internet-based Diabetes Education

Behavioral: Managing Diabetes

Interventions

TeenCopeBEHAVIORAL

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

1
Managing DiabetesBEHAVIORAL

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.

2

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Arizona

Tucson, Arizona, 85721, United States

Location

Yale University School of Nursing

New Haven, Connecticut, 06519, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (8)

  • 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.

    PMID: 10891831BACKGROUND

  • 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.

    PMID: 9614605BACKGROUND

  • 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.

    PMID: 20182161BACKGROUND

  • 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.

    PMID: 22484337BACKGROUND

  • 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.

    PMID: 24163439DERIVED

  • 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.

    PMID: 23579179DERIVED

  • 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.

    PMID: 22960587DERIVED

  • 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.

    PMID: 22274724DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Margaret Grey, DrPh, FAAN, CPNP

    Yale School of Nursing

    PRINCIPAL INVESTIGATOR

  • Robin Whittemore, PhD, APRN

    Yale School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2008

First Posted

May 26, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

April 2, 2020

Record last verified: 2020-03

Locations

US(4)