Family Management of Childhood Diabetes Study
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 9 - 70 |
| Updated: | 4/6/2019 |
| Start Date: | November 8, 2004 |
| End Date: | August 20, 2009 |
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.
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.
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.
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.
- INCLUSION CRITERIA - CHILD CRITERIA:
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
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.
We found this trial at
3
sites
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
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Children's Memorial Hospital, Chicago Ann & Robert H. Lurie Children
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