Diabetes Adolescent and Family Group Therapy

NCT01626586 | Completed

• 1 other identifier: 2012-1200
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Diabetes-related Outcomes

  Diabetes-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.

  8 years

Secondary Outcomes (1)

• Diabetes-related medical outcome data

  8 years

Study Arms (3)

Group Therapy

EXPERIMENTAL

This study includes having an initial assessment completed; participating in a 6 session group therapy intervention over a 7 week time period; and returning at 2 and 4 months after group therapy intervention for "booster" follow-up sessions. During the group intervention sessions, the parent group and the youth group will each meet for about 45 minutes and then the families will come together to work on family goals for the last 15 to 20 minutes.

Behavioral: Group Therapy

Individual Arm

ACTIVE COMPARATOR

This study includes having an initial assessment completed; participating in a 6 session individual therapy intervention over a 7 week time period; and returning at 2 months after the individual therapy intervention for the "booster" follow-up session. During the individual intervention sessions, the youth and the parents will each meet for about 45 minutes and then the families will come together to work on family goals for the last 15 to 20 minutes.

Behavioral: Group Therapy

Recently Diagnosed Arm

ACTIVE COMPARATOR

This study includes enrolling patients with Type 1 Diabetes, who are recently diagnosed (\<1 year) to participate in a 4 session group therapy intervention over a 4 week time period; and returning at 2 months after the last group session for the "booster" follow-up session. During the group sessions, the youth and the parents will each meet for about 45 minutes and then the families will come together to work on family goals for the last 15-20 minutes.

Behavioral: Group Therapy

Interventions

Group Therapy BEHAVIORAL

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.

Group Therapy; Individual Arm; Recently Diagnosed Arm

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Marquette University: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jessica Kichler, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 25, 2012
• Study Start: May 1, 2012
• Primary Completion: February 24, 2020
• Study Completion: February 24, 2020
• Last Updated: February 26, 2020

Record last verified: 2020-02

Locations

US (1)