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DiabetesPhase 1NCT00340938

Family Management of Childhood Diabetes Study

A Phase 1 study testing Blood testing in people with Diabetes and Type 1 Diabetes, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 3 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

This study will test the effectiveness of a practical, low-cost, problem-solving method called WE CAN that can be taught to families at diabetes clinics. The goal is to see if this teaching and support can help with controlling the level of blood sugar in children with type 1 diabetes as they approach adolescence. Read more about this study

Who is it for?
Ages 9 to 70 years
Conditions the study is for
Diabetes, Type 1 Diabetes
What is being tested?
Blood testing
Type of treatment
Surgery or procedure
How many people
1,298 participants
Where
3 sitesUnited States
Study dates
8 Nov 2004to 20 Aug 2009
Phase
Phase 1
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 9 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age 9.0 to 14.5
  • Type I diabetes diagnosis (diagnosed by ADA criteria) for a minimum of 1 year requiring insulin treatment
  • Insulin dose greater than or equal to 0.5 u/kg/day
  • Mean A1c over last 8 months is less than 13.0%
  • No major chronic diseases (except well-controlled thyroid, asthma)
  • No major visual/auditory impairments
Show all 24Show fewer
  • Child is not in self-contained special education class throughout the school day
  • No DSM-IV diagnosis of bipolar, addiction, psychosis, or eating disorder documented in existing medical chart. No record of inpatient hospitalization for mental disorder in past six months including substance abuse rehabilitation, eating disorder units or day treatment programs. No history of anti-psychotic medications for the past 6 months.
  • No diagnosis of mental retardation.
  • Literate (reading, writing) in English/Spanish at 2nd grade level
  • Willing to provide informed assent
  • Children who are currently enrolled in any other study (observational or interventional) are not eligible for enrollment. Children cannot enroll in another study during the course of this study. 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 or who were in an observational study are eligible once they have completed all scheduled study follow-ups.
  • PARENT/FAMILY ENVIRONMENT CRITERIA:
  • Child lives in geographically stable home, no multiple foster homes, boarding school, or institutions expected to next 2 years.
  • The same 1 or 2 adult caregivers have accompanied the child to every diabetes clinic visit in the past year, and a single adult, who has primary responsibility for the child's diabetes care and monitoring, agrees to participate in all aspects of the protocol (single-parent families, blended families and separated parents will be eligible).
  • Family has no plan to re-locate out of area within the next 2 years of the study.
  • Home has telephone access
  • Primary parent is not currently undergoing treatment for substance abuse.
  • Primary parent has not been hospitalized in past 6 months for mental disorder.
  • Primary caretaker has no history of psychosis.
  • Child had at least 2 clinic visits within last 12 months
  • Parent and child wiling to come to clinic every 3 months for duration (2 years) of study.
  • Families who are currently enrolled in any other study (observational or interventional) are not eligible for enrollment. Families cannot enroll in another study during the course of this study. 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 month are also ineligible to participate. However, families who were in a standard care control group in an intervention study or who were in an observational study are eligible once they have completed all scheduled study follow-ups.
  • 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.

Who cannot join

None listed.

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • Childrens Memorial Hospital, Chicago

    Chicago, Illinois, 60614-3394

  • Texas Children's Hospital

    Houston, Texas, 77030

Other trials in United States

About this study

This study will test the effectiveness of a practical, low-cost, problem-solving method called WE CAN that can be taught to families at diabetes clinics. The goal is to see if this teaching and support can help with controlling the level of blood sugar in children with type 1 diabetes as they approach adolescence. Attention would go to young people's completion of tasks necessary to manage diabetes, quality of life, and psychological adjustments, plus the role of the family in these situations. Type 1 diabetes mellitus, accounting for less than 10% of the disease cases, is marked by the inability of the pancreas to secrete insulin. People who have it must consistently manage their disease. Successful disease management for children depends on the family's adaptation to treatment demands. Yet maintaining acceptable blood sugar control becomes more difficult for adolescents, owing to changes in the body during that period of life. Also, early adolescence is a vital time in people's development of health outcomes. The title WE CAN is a way to remember the steps of the problem-solving method:

  • Work together to set goals
  • Explore barriers and solutions
  • Choose the best solutions
  • Act on your plan
  • Note the results
Read more

Children who have reached age 9 but are not yet 14.5 years who have had type 1 diabetes for at least 1 year and who have had at least two visits to diabetes clinics at one of four clinical sites may be eligible for this study. A total of 120 children will participate in clinic visits once every 3 months.

Participants and their families will attend diabetes clinic visits once every 3 months. They will be assigned to one of two groups: standard care or WE CAN. Those in the WE CAN group will have visits about 15 to 45 minutes longer than those involved in the standard care group. All participants will have two home visits: at the beginning and at 6 months. There will also be telephone interviews, about 20 minutes long, once every 3 months with the children and their parents. Medical data will be collected during each visit to the clinic, including blood samples. A health advisor will work with the families. Questionnaires given to parents and children separately will measure diabetes-related family conflict, parent child sharing of responsibilities for the disease, attitudes and emotions about diabetes, and impact of the disease on the child's life. Also, parents and children together will take part in a 10-minute discussion of a diabetes-related issue that has caused friction among family members. They will discuss the problem, come up with possible solutions, and to try to decide on a solution within 10 minutes. Family discussions will be videotaped at the first home visit and at the 6-month home visit.

Families in both groups will receive more detailed monitoring of family diabetes management than is usually the case. Those in the WE CAN group may be able to control diabetes more effectively during the child's early adolescence, though that result is not guaranteed. If the family guidance and support provided by the WE CAN health advisor is effective, children in that group may have better results in blood sugar than they would if they did not participate in the study. Each family member completing the first and 6-month visits and completing each telephone interview will receive payment for participating.

Read the detailed description

This protocol describes 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.

Being tested
Blood testing
Keywords
Adherence, Education, Problem Solving, Motivation, Locus of Responsibility
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 1

What participants receive

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

  • Blood testingProcedure or surgery

Timeline

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

  1. First posted21 Jun 2006 (estimated)
  2. Study start8 Nov 2004
  3. Primary completion1 Mar 2009
  4. Study completion20 Aug 2009

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 1
Primary purpose
Treatment
Enrolment
1,298 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00340938
Sponsor's protocol ID
999905030
Other IDs
05-CH-N030
Status last verified
1 Nov 2019
First submitted
19 Jun 2006
Last updated
17 Dec 2019
Results posted
No

Publications

  • Allen DA, Tennen H, McGrade BJ, Affleck G, Ratzan S. Parent and child perceptions of the management of juvenile diabetes. J Pediatr Psychol. 1983 Jun;8(2):129-41. doi: 10.1093/jpepsy/8.2.129. No abstract available.

    PubMed 6875761
  • Amiel SA, Sherwin RS, Simonson DC, Lauritano AA, Tamborlane WV. Impaired insulin action in puberty. A contributing factor to poor glycemic control in adolescents with diabetes. N Engl J Med. 1986 Jul 24;315(4):215-9. doi: 10.1056/NEJM198607243150402.

    PubMed 3523245
  • Anderson BJ, Brackett J, Ho J, Laffel LM. An office-based intervention to maintain parent-adolescent teamwork in diabetes management. Impact on parent involvement, family conflict, and subsequent glycemic control. Diabetes Care. 1999 May;22(5):713-21. doi: 10.2337/diacare.22.5.713.

    PubMed 10332671

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Blood testing in people with Diabetes and Type 1 Diabetes, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 3 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 24 inclusion and 0 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 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00340938, which also lists 3 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 17 Dec 2019.

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