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.
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
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.
- Conditions
- Diabetes, Type 1 Diabetes
- 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.
- First posted21 Jun 2006 (estimated)
- Study start8 Nov 2004
- Primary completion1 Mar 2009
- Study completion20 Aug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Tonja R. Nansel, Ph.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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 6875761Amiel 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 3523245Anderson 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Management of Childhood Diabetes Study
- ClinicalTrials.gov ID
- NCT00340938
- Acronym / sponsor ID
- 999905030
- Conditions
- Diabetes, Type 1 Diabetes
- Keywords
- Adherence, Education, Problem Solving, Motivation, Locus of Responsibility
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,298 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 8 Nov 2004
- Primary completion
- 1 Mar 2009 (actual)
- Study completion
- 20 Aug 2009 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 9 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (24 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testing | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 6875761Allen 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.
- Background: PubMed 3523245Amiel 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.
- Background: PubMed 10332671Anderson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tonja R. Nansel, Ph.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
3 sites in 1 country: see every site and its status.
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.