Please select the eligibility criteria that correspond to the clinical trial below.
Title: Family Management of Childhood Diabetes Study
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.


Options:
A: Inclusion criteria:

A. The child of the parent/caregiver has a diagnosis of asthma made by a physician and reported by the parent, or diagnosis of asthma made during the ED visit if the child has experienced two previous wheezing episodes.

B. The child will undergo treatment during the enrollment ED visit for the current asthma exacerbation, as determined by the treating ED clinician. As a result, only parents/caregivers with children experiencing a significant wheezing episode will be entered into the study.

C. The child is 2-10 years of age (second birth date until, but not including, eleventh birth date).

D. The child has Medicaid or no medical insurance. This criterion permits easy identification and selection of low-income children/families, who are the target population for this proposal.

E. The parent/caregiver has a working telephone at home. F. The child attends one of the target practices (7 private practices and 5 federally funded clinics) for routine care.

G. The parent/caregiver and child live within the St. Louis metro area.

Exclusion criteria:

A. The child attends a practice other than the target group. B. The parent/caregiver and child live outside of the St. Louis metro area. C. The child has a chronic illness other than asthma that manifests as wheezing or respiratory symptoms.

D. The parent/caregiver does not have a working telephone in home. E. The parent/caregiver is not able to effectively communicate in English.
B: Inclusion Criteria:

* Mothers of any age with a child diagnosed with any form of cancer 2-16 weeks prior to contact.

Exclusion Criteria:

* Mothers of children with cancer if they do not read or speak English or Spanish, if their child is in severe medical crisis, or if they live a prohibitive distance to complete the intervention.
C: Inclusion Criteria:

* child experienced at least 3 episodes of abdominal pain over a 3-month period which affected his/her activities
* primary caregiver willing and able to complete questionnaires
* child aged 7-17
* child has lived with the primary caregiver full-time for at least the past 5 years and for at least half of his/her lifetime

Exclusion Criteria:

* positive physical or laboratory findings which would explain the child's abdominal pain
* chronic disease
* major surgery in past year
* developmental disabilities that require full-time special education or impair ability to respond
* inability to comprehend English
D: Child Inclusion Criteria:

* 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.

Parent/Family Environment Inclusion Criteria

* 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.

Child Exclusion Criteria:

* 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.

Parent/Family Environment Exclusion Criteria

* 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.

Answer: D