Type 1 Diabetes MellitusPhase 3NCT00358059
Behavior Therapy for Families of Diabetic Adolescents
A Phase 3 study testing Behavioral Family Systems Therapy for Diabetes in people with Type 1 Diabetes Mellitus, run by Nemours Children's Clinic at 2 sites in United States.
Trial summary
Effective adaptation to type 1 diabetes mellitus requires adolescents and their families to work together effectively to solve problems and resolve disagreements in order to achieve acceptable diabetic control and treatment adherence. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Behavioral Family Systems Therapy for Diabetes
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2000to Jan 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age of adolescent 12-<17 years Type 1 diabetes for >2 years Living in a home environment English reading ability at 5th grade level or above Established diabetes care at participating site Working telephone service Intent to remain living in same region for next 18 months -
Who cannot join
- Presence of another chronic systemic disease Inpatient psychiatric treatment of patient or caregiver in prior 6 months Current outpatient treatment of psychosis, major depression or substance use disorder in parent/caregiver
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Nemours Children's Clinic
Jacksonville, Florida, 32207
Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110
About this study
Effective adaptation to type 1 diabetes mellitus requires adolescents and their families to work together effectively to solve problems and resolve disagreements in order to achieve acceptable diabetic control and treatment adherence. Many studies show that problematic family communication, insufficient parental involvement in care and parent-adolescent conflict are associated with poor adherence and poor diabetic control. This study tests a family communication and problem solving intervention by randomizing families of adolescent with type 1 diabetes to 6 months' treatment either with the experimental intervention, continuation in standard medical care for diabetes, or participation in a multifamily educational support group. Families are then followed for an additional 12 months to examine the longer-term effects of the interventions on the targeted diabetes outcomes.
Read the detailed description
Adolescents with Type 1 diabetes mellitus often struggle to maintain adequate treatment adherence and diabetic control, leading to preventable hospitalizations and emergency room visits. Numerous cross-sectional and prospective studies show that family communication and conflict resolution skills are important influences on adolescents' diabetic control, treatment adherence and psychological adjustment. Empirical validation of psychological interventions targeting these processes could reduce excess health care costs and risks of diabetic complications. In the parent grant, we showed that Behavioral Family Systems Therapy (BFST; Robin \& Foster, 1989) yielded improvements in family communication skills and parent-adolescent relationships, but it had weaker and less durable effects on treatment adherence and diabetic control. In this competing continuation application, we have relied on extensive preliminary data, our clinical experience with BFST and the results of others' investigations to formulate refinements to BFST that are designed to maximize its impact on diabetes treatment adherence and metabolic control. These include required targeting of behavioral barriers to adherence and diabetic control for every family, lengthening treatment from 3 to 6 months, and incorporation of several treatment components that were shown to be effective in other studies. We propose a randomized, controlled trial of this refined BFST intervention compared with standard medical therapy or participation in a diabetes educational support group on measures of: family communication, parent-adolescent relationships, adolescent psychological adjustment, treatment adherence, diabetic control and health care use. We will analyze predictors of treatment outcome and evaluate the clinical significance, social validity and maintenance of treatment effects over 6month and 12-month follow-up intervals. The results could influence the clinical practice of diabetes management and health care policy regarding adolescents with diabetes and other chronic diseases.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Behavioral Family Systems Therapy for Diabetes
- Keywords
- diabetes mellitus, adolescence, adherence, glycemic control, adaptation, communication
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Family Systems Therapy for DiabetesBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated hemoglobin (HbA1c)
Treatment adherence
Secondary outcomes (3)
Parent-adolescent communication
Family problem solving and conflict resolution skills
Diabetes-related quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2006 (estimated)
- Study startOct 2000
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Investigators
- Tim Wysocki, Ph.D., Principal investigator, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358059
- Sponsor's protocol ID
- R01DK043802
- Status last verified
- Oct 2005
- First submitted
- 26 Jul 2006
- Last updated
- 28 Jul 2006
- Results posted
- No
Publications
Wysocki T, Harris MA, Buckloh LM, Mertlich D, Lochrie AS, Taylor A, Sadler M, Mauras N, White NH. Effects of behavioral family systems therapy for diabetes on adolescents' family relationships, treatment adherence, and metabolic control. J Pediatr Psychol. 2006 Oct;31(9):928-38. doi: 10.1093/jpepsy/jsj098. Epub 2006 Jan 9.
PubMed 16401678
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavior Therapy for Families of Diabetic Adolescents
- ClinicalTrials.gov ID
- NCT00358059
- Acronym / sponsor ID
- R01DK043802
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- diabetes mellitus, adolescence, adherence, glycemic control, adaptation, communication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- Oct 2000
- Study completion
- Jan 2006
- First posted
- 28 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effective adaptation to type 1 diabetes mellitus requires adolescents and their families to work together effectively to solve problems and resolve disagreements in order to achieve acceptable diabetic control and treatment adherence. Many studies show that problematic family communication, insufficient parental involvement in care and parent-adolescent conflict are associated with poor adherence and poor diabetic control. This study tests a family communication and problem solving intervention by randomizing families of adolescent with type 1 diabetes to 6 months' treatment either with the experimental intervention, continuation in standard medical care for diabetes, or participation in a multifamily educational support group. Families are then followed for an additional 12 months to examine the longer-term effects of the interventions on the targeted diabetes outcomes.
Detailed description
Adolescents with Type 1 diabetes mellitus often struggle to maintain adequate treatment adherence and diabetic control, leading to preventable hospitalizations and emergency room visits. Numerous cross-sectional and prospective studies show that family communication and conflict resolution skills are important influences on adolescents' diabetic control, treatment adherence and psychological adjustment. Empirical validation of psychological interventions targeting these processes could reduce excess health care costs and risks of diabetic complications. In the parent grant, we showed that Behavioral Family Systems Therapy (BFST; Robin \& Foster, 1989) yielded improvements in family communication skills and parent-adolescent relationships, but it had weaker and less durable effects on treatment adherence and diabetic control. In this competing continuation application, we have relied on extensive preliminary data, our clinical experience with BFST and the results of others' investigations to formulate refinements to BFST that are designed to maximize its impact on diabetes treatment adherence and metabolic control. These include required targeting of behavioral barriers to adherence and diabetic control for every family, lengthening treatment from 3 to 6 months, and incorporation of several treatment components that were shown to be effective in other studies. We propose a randomized, controlled trial of this refined BFST intervention compared with standard medical therapy or participation in a diabetes educational support group on measures of: family communication, parent-adolescent relationships, adolescent psychological adjustment, treatment adherence, diabetic control and health care use. We will analyze predictors of treatment outcome and evaluate the clinical significance, social validity and maintenance of treatment effects over 6month and 12-month follow-up intervals. The results could influence the clinical practice of diabetes management and health care policy regarding adolescents with diabetes and other chronic diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age of adolescent 12-<17 years Type 1 diabetes for >2 years Living in a home environment English reading ability at 5th grade level or above Established diabetes care at participating site Working telephone service Intent to remain living in same region for next 18 months -
Key exclusion criteria (2 listed)
- Presence of another chronic systemic disease Inpatient psychiatric treatment of patient or caregiver in prior 6 months Current outpatient treatment of psychosis, major depression or substance use disorder in parent/caregiver
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Family Systems Therapy for Diabetes | Behavioural | – |
Primary outcome
Glycosylated hemoglobin (HbA1c)
Treatment adherence
3 secondary outcomes
Parent-adolescent communication
Family problem solving and conflict resolution skills
Diabetes-related quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2006.
- Results publication: PubMed 16401678Wysocki T, Harris MA, Buckloh LM, Mertlich D, Lochrie AS, Taylor A, Sadler M, Mauras N, White NH. Effects of behavioral family systems therapy for diabetes on adolescents' family relationships, treatment adherence, and metabolic control. J Pediatr Psychol. 2006 Oct;31(9):928-38. doi: 10.1093/jpepsy/jsj098. Epub 2006 Jan 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Wysocki, Ph.D. principal investigator
Nemours Children's Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Behavioral Family Systems Therapy for Diabetes in people with Type 1 Diabetes Mellitus, run by Nemours Children's Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycosylated hemoglobin (HbA1c). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00358059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2006.