Study of Intensive, Home-Based Family Therapy to Improve Illness Management in Youth With Diabetes

NCT ID: NCT00372814

Last Updated: 2017-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2011-01-31

Brief Summary

The study is a randomized clinical trial testing the effectiveness of Multisystemic Therapy (MST) for improving the treatment adherence, metabolic control and quality of life of urban adolescents with poorly controlled insulin dependent diabetes.

Detailed Description

The deterioration in regimen adherence and metabolic control associated with the adolescent developmental period is well-documented. However, a subset of high-risk adolescents with diabetes demonstrate much more serious adherence problems, as evidenced by chronically poor metabolic control (CPMC) and post-diagnostic admissions for diabetic ketoacidosis (DKA). Adolescents in CPMC represent a group at high risk for both short and long term diabetes complications and are therefore heavy users of medical resources and health care dollars. Minority and low-income children are over-represented among adolescents with CPMC.

The design for the proposed study is a randomized, controlled trial with a repeated measures design using a sample of 170 adolescents, 85 of whom will receive MST and 85 of whom will receive a telephone intervention to test the effect of increased attention (control condition). Subjects must have a current hemoglobin A1C (HbA1c) of >8% and an average HbA1c of >8% during the past year, must be diagnosed with insulin dependent diabetes for at least one year, be 10-17 years of age and reside in the metro Detroit tri-county area. Exclusion criteria are severe mental impairment/thought disorder, non-English speaking patient/parent or a co-morbid major medical condition such as cystic fibrosis. Families who are randomized to MST receive intensive, home-based family therapy for approximately six months. MST is a community based treatment originally designed for use with adolescents presenting with serious mental health problems, but which is adapted in the present study for use with chronically ill youth and serious adherence difficulties. Therapists meet with families two to three times per week at the beginning of treatment with a decreasing number of sessions at the end of treatment.

Conditions

Diabetes Mellitus, Insulin Dependent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Multisystemic Therapy (MST)

Adolescents receiving MST will receive Intensive Home-Based Family Therapy which will consist of home-based, family psychotherapy sessions 2-3 times a week, lasting 60 minutes in duration from a pediatric mental health worker for six months. The purpose of the therapy sessions are to improve the youths' ability to complete their daily diabetes illness management tasks, reduce average blood glucose levels and improve metabolic control.

Group Type: EXPERIMENTAL

Intensive Home-Based Family Therapy

Intervention Type: BEHAVIORAL

Multisystemic Therapy (MST): Adolescents receiving MST will receive home-based, family psychotherapy sessions 2-3 times a week, lasting 60 minutes in duration from a pediatric mental health worker for six months. The purpose of the therapy sessions are to improve the youths' ability to complete their dilay diabetes illness management tasks, reduce average blood glucose levels and improve metabolic control.

Telephone Support Calls

Adolescents receiving Supportive Telephone Calls (TS) will receive weekly 30 minute phone calls from a pediatric mental health worker for six months. The purpose of the call is to provide emotional support regarding the adolescent's chronic medical condition, assess adherence to the prescribed regimen and to help the adolescent brainstorm solutions to any barriers they identify to completion of diabetes care.

Group Type: ACTIVE_COMPARATOR

Supportive Telephone Calls

Intervention Type: BEHAVIORAL

Telephone Support Calls: Adolescents receiving TS will receive weekly 30 minute phone calls from a pediatric mental health worker for six months. The purpose of the call is to provide emotional support regarding the adolescent's chronic medical condition, assess adherence to the prescribed regimen and to help the adolescent brainstorm solutions to any barriers they identify to completion of diabetes care.

Interventions

Intensive Home-Based Family Therapy

Multisystemic Therapy (MST): Adolescents receiving MST will receive home-based, family psychotherapy sessions 2-3 times a week, lasting 60 minutes in duration from a pediatric mental health worker for six months. The purpose of the therapy sessions are to improve the youths' ability to complete their dilay diabetes illness management tasks, reduce average blood glucose levels and improve metabolic control.

Intervention Type: BEHAVIORAL

Supportive Telephone Calls

Telephone Support Calls: Adolescents receiving TS will receive weekly 30 minute phone calls from a pediatric mental health worker for six months. The purpose of the call is to provide emotional support regarding the adolescent's chronic medical condition, assess adherence to the prescribed regimen and to help the adolescent brainstorm solutions to any barriers they identify to completion of diabetes care.

Intervention Type: BEHAVIORAL

Other Intervention Names

Multisystemic Therapy, MST; TS

Eligibility Criteria

Inclusion Criteria

• insulin dependent Type 1 or Type 2 diabetes
• diagnosed with diabetes ≥ 1 year
• current HbA1c ≥ 8%
• average HbA1c ≥ 8% over the past year
• aged 10 -17
• patient of Children's Hospital of Michigan Diabetes Clinic
• lives within 30 miles of Children's Hospital of Michigan

Exclusion Criteria

• moderate to severe mental retardation (unable to complete study measures)
• psychosis or current suicidal intent
• any medical diagnosis that alters standard diabetes care

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Deborah Ellis, Ph.D.

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah A. Ellis, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

Children's Hospital of Michigan

Detroit, Michigan, United States

Countries

United States

References

Ellis DA, Naar-King S, Chen X, Moltz K, Cunningham PB, Idalski-Carcone A. Multisystemic therapy compared to telephone support for youth with poorly controlled diabetes: findings from a randomized controlled trial. Ann Behav Med. 2012 Oct;44(2):207-15. doi: 10.1007/s12160-012-9378-1.

Reference Type: RESULT

PMID: 22644587 (View on PubMed)

Carcone AI, Ellis DA, Chen X, Naar S, Cunningham PB, Moltz K. Multisystemic Therapy Improves the Patient-Provider Relationship in Families of Adolescents with Poorly Controlled Insulin Dependent Diabetes. J Clin Psychol Med Settings. 2015 Sep;22(2-3):169-78. doi: 10.1007/s10880-015-9422-y.

Reference Type: RESULT

PMID: 25940767 (View on PubMed)

Other Identifiers

R01DK059067

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK59067B (completed)

Identifier Type: -

Identifier Source: org_study_id