Clinical trial NCT01626586: Diabetes Adolescent and Family Group Therapy
Official title: Adjustment and Self-Management Intervention Groups for Youth With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Youth
Family
Group Therapy
Type 1 Diabetes Mellitus
Self-Management
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Marquette University
First posted: 2012-06-25
Enrollment: 49
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this research study the investigators want more about how being in a group about diabetes helps your family versus individual treatment. The investigators are now asking youth with recently diagnosed (\<1 year) diabetes and their parents to be in the research, because the investigators want to see if this diabetes group and/or individual therapy is helpful to your coping, adjustment, and family communication about diabetes.

Detailed description: The purpose of this research study is to find out what effects the Group Therapy Project has on parents and child's management of Type 1 Diabetes Mellitus (T1DM) from both a group versus an individual therapy modality. We want to start a group and individual therapy program that looks at youth and family adjustment and coping at the Cincinnati Children's Hospital with patients who have T1DM. There has been research before on this group therapy and we want to look at it in a "typical" clinical setting at Cincinnati Children's Hospital for both group and individual therapy, including recently diagnosed patients (\<1 year). This research is being done to understand how a peer and family-based group versus individual therapy can be helpful by looking at survey data as well as medical data before and after participating in the diabetes therapy program. This information will help us further develop prevention and intervention programs for other youth with T1DM and their families.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Type 1 Diabetes,
* Aged 10.0 - 17.9 years of age,
* At least one parent/caregiver to participate with them,
* Diagnosed for at least 6 months for the Group and the Individual Arms.
* Diagnosed for \<1 year for the Recently Diagnosed Arm

Exclusion Criteria:

* Potential participants will be excluded if:

  * They have a co-existing diagnosis of mental retardation, pervasive developmental disorder, substance abuse, eating disorders, psychosis, or other acute psychiatric or medical needs, such as suicidality
  * They are not fluent in the English language.

Primary outcomes:
measure: Diabetes-related Outcomes
timeFrame: 8 years
Secondary outcomes:
measure: Diabetes-related medical outcome data
timeFrame: 8 years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jessica Kichler, PhD
role: PRINCIPAL_INVESTIGATOR
References: