NCT00745342

Brief Summary

This 2-year randomized, controlled trial examined the impact of a clinic-based, family teamwork intervention on glycemic control in youth with recently diagnosed type 1 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 1999

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2002

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
Last Updated

August 4, 2021

Status Verified

August 1, 2021

Enrollment Period

3.6 years

First QC Date

August 29, 2008

Last Update Submit

August 3, 2021

Conditions

Type 1 Diabetes Mellitus

Keywords

type 1 diabetesglycemic controlfamily conflictquality of lifeparental involvement

Outcome Measures

Primary Outcomes (1)

  • Glycemic control, assessed by hemoglobin A1c

    Change in A1c from baseline to 2 years, measured every 3 months

    2 years

Secondary Outcomes (3)

  • Youth quality of life, measured using the youth PedsQL survey and the parent-proxy PedsQL survey

    2 years

  • Diabetes-specific family conflict, measured using the Diabetes Family Conflict survey (youth and parent versions)

    2 years

  • Parent involvement in diabetes management tasks, measured using the Diabetes Family Responsibility Questionnaire (youth and parent versions)

    2 years

Study Arms (2)

Teamwork Group

EXPERIMENTAL

Families randomized to the Teamwork Group received the behavioral family teamwork intervention.

Behavioral: Family Teamwork Intervention

Standard Care

NO INTERVENTION

Families in the Standard Care group received standard diabetes care and equal attention from study staff between visits to schedule appointments and encourage regular diabetes follow-up care.

Interventions

Family Teamwork InterventionBEHAVIORAL

Families in the teamwork group received quarterly psychoeducational interventions at regular clinic visits, focusing on promoting family teamwork and reducing diabetes-specific family conflict and diabetes burnout.

Teamwork Group

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • to 17 years old
  • Duration of type 1 diabetes between 2 months and 6 years
  • Residence in New England or New York
  • At least 1 outpatient visit in the past year

You may not qualify if:

  • Major co-morbid psychiatric or medical illness in youth
  • Diagnosis of an active major psychiatric disorder in either parent
  • Diagnosis of a life-threatening medical illness in either parent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (3)

  • Anderson BJ, Vangsness L, Connell A, Butler D, Goebel-Fabbri A, Laffel LM. Family conflict, adherence, and glycaemic control in youth with short duration Type 1 diabetes. Diabet Med. 2002 Aug;19(8):635-42. doi: 10.1046/j.1464-5491.2002.00752.x.

    PMID: 12147143RESULT

  • Laffel LM, Vangsness L, Connell A, Goebel-Fabbri A, Butler D, Anderson BJ. Impact of ambulatory, family-focused teamwork intervention on glycemic control in youth with type 1 diabetes. J Pediatr. 2003 Apr;142(4):409-16. doi: 10.1067/mpd.2003.138.

    PMID: 12712059RESULT

  • Laffel LM, Connell A, Vangsness L, Goebel-Fabbri A, Mansfield A, Anderson BJ. General quality of life in youth with type 1 diabetes: relationship to patient management and diabetes-specific family conflict. Diabetes Care. 2003 Nov;26(11):3067-73. doi: 10.2337/diacare.26.11.3067.

    PMID: 14578241RESULT

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

  • Lori MB Laffel, MD, MPH

    Joslin Diabetes Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Pediatric, Adolescent, & Young Adult Section; Investigator, Genetics & Epidemiology Section

Study Record Dates

First Submitted

August 29, 2008

First Posted

September 3, 2008

Study Start

March 1, 1999

Primary Completion

October 1, 2002

Study Completion

October 1, 2002

Last Updated

August 4, 2021

Record last verified: 2021-08

Locations

US(1)