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Diabetes Adolescent and Family Group Therapy

Adjustment and Self-Management Intervention Groups for Youth With Type 1 Diabetes Mellitus

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01626586
Enrollment
49
Registered
2012-06-25
Start date
2012-05-31
Completion date
2020-02-24
Last updated
2020-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

Youth, Family, Group Therapy, Type 1 Diabetes Mellitus, Self-Management

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.

Interventions

BEHAVIORALGroup Therapy

Self-management Diabetes Protocol: Successful adjustment to daily diabetes management requires a wealth of clinical knowledge, solid problem-solving and coping skills to deal with the physical, social and emotional factors associated with caring for and living with a chronic illness, and motivation to take care of one's health.

Sponsors

Marquette University
CollaboratorOTHER
Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Diabetes-related Outcomes8 yearsDiabetes-related improvements for the youths and their parents (e.g., diabetes responsibility, adherence, and parent-child interactions) from baseline to post-treatment, maintenance of these changes over the 2 and 4 month follow-up.

Secondary

MeasureTime frameDescription
Diabetes-related medical outcome data8 yearsMedical improvements for youth (e.g., HbA1c) pre- to post-treatment and maintained at 6 months after the last booster session. Decreased health care utilization for the youth (e.g., emergency room visits and inpatient hospitalizations) pre- to post-treatment and maintained at 6 months after the last booster session.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026