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Type 1 DiabetesPhase 3NCT00684658

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

A Phase 3 study testing TeenCope and Managing Diabetes in people with Type 1 Diabetes, run by Yale University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 to 14 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
TeenCope and Managing Diabetes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
4 sitesUnited States
Study dates
May 2008to May 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Miami

    Miami, Florida, 33136

  • Yale University School of Nursing

    New Haven, Connecticut, 06519

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • University of Arizona

    Tucson, Arizona, 85721

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Type 1 Diabetes
Being tested
TeenCope, Managing Diabetes
Keywords
Type 1 Diabetes, Children and Teenagers, Coping with Chronic Illness, Adolescence, Internet psychosocial program, Coping Skills Training
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TeenCopeBehavioural

    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

  • Managing DiabetesBehavioural

    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.

Study groups in NCT00684658
Study groupRoleWhat they receive
1ExperimentalTeenCope: Internet-based Coping Skills Training
Receives: Behavioral: TeenCope
2Active comparatorManaging Diabetes: Internet-based Diabetes Education
Receives: Behavioral: Managing Diabetes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemoglobin A1c (HbA1c)

    Measured: 18 months

  2. Pediatric Quality of Life Inventory (PedsQL)

    Measured: 18 months

Secondary outcomes (8)

  1. Perceived Stress Scale (PSS)

    Measured: 18 months

  2. Self-Efficacy for Diabetes Scale

    Measured: 18 months

  3. Children's Depression Inventory

    Measured: 18 months

  4. Self-Perception Profile for Adolescents

    Measured: 18 months

  5. Responses to Stress Questionaire (RSQ)

    Measured: 18 months

  6. Diabetes Family Behavior Scale

    Measured: 18 months

  7. Self Management of Type 1 Diabetes

    Measured: 18 months

  8. Diabetes Conflict

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionMay 2012
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00684658
Sponsor's protocol ID
0711003291
Other IDs
R01NR004009
Status last verified
Mar 2020
First submitted
21 May 2008
Last updated
2 Apr 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 10891831

  • 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.

    PubMed 9614605

  • 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.

    PubMed 20182161

  • 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.

    PubMed 22484337

  • 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.

    PubMed 24163439

  • 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.

    PubMed 23579179

  • 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.

    PubMed 22960587

  • 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.

    PubMed 22274724

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TeenCope and Managing Diabetes in people with Type 1 Diabetes, run by Yale University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin A1c (HbA1c) (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00684658, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.

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