NCT00273286

Brief Summary

This is a multi-center, randomized controlled trial to test whether a clinic-integrated, low intensity, multi-component behavioral intervention is effective in preventing the deterioration in glycemic control, treatment adherence, and quality of life that commonly occur during late childhood and early adolescence in youth with type 1 diabetes. The study will also examine mechanisms and processes that influence the effectiveness of family management of diabetes during this developmental period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
422

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2006

Typical duration for phase_2

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

January 1, 2006

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

May 13, 2011

Status Verified

April 1, 2011

Enrollment Period

3.2 years

First QC Date

January 5, 2006

Last Update Submit

May 11, 2011

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Insulin-DependentDiabetes Mellitus, Juvenile-OnsetIDDMType 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • glycemic control

    HbA1c

    1/2006-3/2009

  • treatment adherence

    Diabetes Self Management Profile

    1/2006-3/2009

Secondary Outcomes (1)

  • quality of life

    1/2006-3/2009

Study Arms (1)

family diabetes management intervention

EXPERIMENTAL

A trained health advisor will be responsible for interactions with parents and patients prior to each diabetes clinic visit (Preparation Phase), at the time of the diabetes clinic visit (Consolidation Phase) and by phone, e-mail, etc. after the clinic visit (Follow-up Phase). Using educational modules developed for the study, families will be engaged in problem identification and solving activities to improve shared parent-youth responsibility for diabetes management and foster increased adolescent's independent management capabilities.

Behavioral: family diabetes management intervention

Interventions

family diabetes management interventionBEHAVIORAL

a clinic-integrated, low intensity, multi-component behavioral intervention

family diabetes management intervention

Eligibility Criteria

Age108 Months - 174 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 9.0 to \<14.5.
  • Type 1 diabetes diagnosis (diagnosed by ADA criteria) for a minimum of 1 year for the main subgroup or 3 months for the recent onset subgroup.
  • Insulin dose greater than or equal to 0.5 u/kg/day for the main subgroup or 0.2 u/kg/day for the recent onset subgroup; with 2 or more daily injections or use of insulin pump.
  • Most recent A1c is \>6.0% and \<13.0%; \<12.0% for those diagnosed for less than 1 year.
  • Willing to provide informed assent.
  • Child lives in geographically stable home, no multiple foster homes, boarding school, or institutions expected in next 2 years.
  • The same 1 or 2 adult caregivers have accompanied the child to every diabetes clinic visit in the past year, and at least 1 caregiver agrees to participate in all aspects of the protocol (single-parent families, blended families, and separated parents will be eligible).
  • Home has telephone access.
  • Child had at least 2 clinic visits within last 12 months.
  • Parent and child willing to come to clinic every 3 months for duration (2 years) of study.
  • If a family has more than one eligible child, all qualifying children who provide consent/assent will participate in assessment and intervention or control activities; however, only the oldest qualifying child will be included in statistical analyses.

You may not qualify if:

  • Presence of a major chronic diseases (except well-controlled thyroid, asthma, celiac).
  • Presence of a major visual/auditory impairments.
  • Child is in a self-contained special education class throughout the school day.
  • Record of inpatient hospitalization for mental disorder in past six months including substance abuse rehabilitation, eating disorder units or day treatment programs. Current diagnosis of eating disorder. History of anti-psychotic medications for the past 6 months.
  • Diagnosis of mental retardation.
  • Unable to read and write English at 2nd grade level.
  • Children who are currently enrolled in any intervention study are not eligible for enrollment. Those who have been in an intervention arm of a trial of a behavioral, psychological or psychoeducational intervention and concluded their study follow-up within the past 12 months are also ineligible to participate. However, children who were in a standard care control group in an intervention study are eligible once they have completed all scheduled study follow-ups. Children cannot enroll in another intervention study during the course of this study. Enrollment of children who are currently participating in another observational study will be at the discretion of the site principal investigator.
  • Family has plans to re-locate out of area within the next 2 years of the study.
  • Participating caretaker is currently undergoing treatment for substance abuse.
  • Participating caretaker has been hospitalized in past 6 months for mental disorder.
  • Participating caretaker has history of psychosis.
  • Families who are currently enrolled in any intervention study are not eligible for enrollment. Those who have been in an intervention arm of a trial of a behavioral, psychological or psychoeducational intervention and concluded their study follow-up within the past 12 months are also ineligible to participate. However, families who were in a standard care control group in an intervention study are eligible once they have completed all scheduled study follow-ups. Families cannot enroll in another intervention study during the course of this study. Enrollment of families who are currently participating in another observational study will be at the discretion of the site principal investigator.
  • The family must reside within 90 miles (one-way) of the clinic (main or satellite), or agree to meet at a mutually agreed upon closer location for conduct of the home assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Nemours Children's Clinic

Jacksonville, Florida, 32207-8426, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (4)

  • Temmen CD, Lu R, Gee BT, Chen Z, Nansel TR. Latent classifications of parental involvement in diabetes management for youth with type 1 diabetes: A randomized clinical trial. Pediatr Diabetes. 2022 Nov;23(7):1133-1142. doi: 10.1111/pedi.13397. Epub 2022 Aug 19.

    PMID: 36250647DERIVED

  • Nansel TR, Thomas DM, Liu A. Efficacy of a Behavioral Intervention for Pediatric Type 1 Diabetes Across Income. Am J Prev Med. 2015 Dec;49(6):930-4. doi: 10.1016/j.amepre.2015.05.006. Epub 2015 Jul 29.

    PMID: 26231856DERIVED

  • Nansel TR, Lipsky LM, Iannotti RJ. Cross-sectional and longitudinal relationships of body mass index with glycemic control in children and adolescents with type 1 diabetes mellitus. Diabetes Res Clin Pract. 2013 Apr;100(1):126-32. doi: 10.1016/j.diabres.2012.12.025. Epub 2013 Jan 20.

    PMID: 23339757DERIVED

  • Nansel TR, Iannotti RJ, Liu A. Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial. Pediatrics. 2012 Apr;129(4):e866-73. doi: 10.1542/peds.2011-2858. Epub 2012 Mar 5.

    PMID: 22392172DERIVED

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

  • Bruce Simons-Morton, PhD

    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

January 5, 2006

First Posted

January 9, 2006

Study Start

January 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

May 13, 2011

Record last verified: 2011-04

Locations

US(4)