Behavioral Family Therapy and Type One Diabetes
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online Learning Modules
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria:
- age 2 to 17 years
- newly diagnosed (within the past 12 weeks) with T1D
- seeking care at UC Davis
Exclusion Criteria:
- Families will be excluded if the child has severe underlying psychiatric, behavioral or medical conditions which could independently affect parental marital stress
Sites / Locations
- University of California-Davis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Online Family Education Modules
Control
Arm Description
Patients will receive online family education modules.
Patients will not receive any intervention.
Outcomes
Primary Outcome Measures
Change in HbA1c Level
The main outcome variable will be the change in glycemic control measured as the mean HbA1c level over the two years following study enrollment.
Secondary Outcome Measures
Behavioral Affect Rating
22 item assessment of the level of hostility and warmth/supportiveness that each parent has received from his or her partner over the prior month-married parents will complete; Scale range is 1 (always)-7 (never); sclae is divided into two parts, hostility and warmth/support (higher values indicate higher hostility or higher warmth/support)
Child Perception of Interparental Conflict (CPIC)
Child's assessment of conflict between parents (completed by children ages 6-18 years of married parents); scale range is 1 (best)-5 (worst), Questions 1 and 4 are reverse scored
Family Assessment Device-General Functioning Subscale
Parent reported measure of family environment; Reverse odd questions, Average of all question: 1>x<4; Higher scores indicate more problematic perception of family function.
Patient-Reported Outcomes Information System- Short Forms (PROMIS)
A bank of measures that examine aspects of individuals' physical, social, and mental health; Average of questions 1>x<5 (Higher scores indicated more perceived support)
FoH-C Frequency of Help
10 item assessment of who provides support in the home for diabetes management tasks; Average of items: 1>x>5; higher scores indicate greater frequency of help
Full Information
NCT ID
NCT03720912
First Posted
October 22, 2018
Last Updated
October 18, 2023
Sponsor
University of California, Davis
Collaborators
University of Nevada, Reno
1. Study Identification
Unique Protocol Identification Number
NCT03720912
Brief Title
Behavioral Family Therapy and Type One Diabetes
Official Title
Effect of Behavioral Family Therapy on Glycemic Control in Children With Type One Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
October 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
University of Nevada, Reno
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Behavioral family therapy, specifically focused on insuring support for the primary caregiver of a child with type one diabetes mellitus and healthy family dynamics, may improve the child's glycemic control as measured by hemoglobin A1c level (HbA1c).
Detailed Description
The success or failure of type 1 diabetes mellitus (T1D) management in children depends not only on access to care, diabetes technologies and diabetes education, but also on the abilities of the patient and his/her family to carry out complex demands. Recent data show that family dynamics play a critical role in determining glycemic control in pediatric patients with T1D. The investigators prior work (Loomba-Albrecht and Glaser, unpublished data) suggests that the strongest determinants of glycemic control are factors related to the primary caregiver's involvement in supportive relationships with others, either a spouse or other family members. This provides a potential therapeutic target to improve outcomes for children with T1D.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will be masked to the participant's assignment. Others (participant, care provider, investigator) cannot be masked to assignment because one group will be receiving the behavioral health intervention and the other will not be receiving anything additional.
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Online Family Education Modules
Arm Type
Experimental
Arm Description
Patients will receive online family education modules.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will not receive any intervention.
Intervention Type
Behavioral
Intervention Name(s)
Online Learning Modules
Intervention Description
The modules will include information about common family management skills: social support, problem solving, communication, and supportive behavior change strategies.
Primary Outcome Measure Information:
Title
Change in HbA1c Level
Description
The main outcome variable will be the change in glycemic control measured as the mean HbA1c level over the two years following study enrollment.
Time Frame
6, 12, 18, and 24 months
Secondary Outcome Measure Information:
Title
Behavioral Affect Rating
Description
22 item assessment of the level of hostility and warmth/supportiveness that each parent has received from his or her partner over the prior month-married parents will complete; Scale range is 1 (always)-7 (never); sclae is divided into two parts, hostility and warmth/support (higher values indicate higher hostility or higher warmth/support)
Time Frame
At enrollment and approximately 3 months after enrollment
Title
Child Perception of Interparental Conflict (CPIC)
Description
Child's assessment of conflict between parents (completed by children ages 6-18 years of married parents); scale range is 1 (best)-5 (worst), Questions 1 and 4 are reverse scored
Time Frame
At enrollment and approximately 3 months after enrollment
Title
Family Assessment Device-General Functioning Subscale
Description
Parent reported measure of family environment; Reverse odd questions, Average of all question: 1>x<4; Higher scores indicate more problematic perception of family function.
Time Frame
At enrollment and approximately 3 months after enrollment
Title
Patient-Reported Outcomes Information System- Short Forms (PROMIS)
Description
A bank of measures that examine aspects of individuals' physical, social, and mental health; Average of questions 1>x<5 (Higher scores indicated more perceived support)
Time Frame
At enrollment and approximately 3 months after enrollment
Title
FoH-C Frequency of Help
Description
10 item assessment of who provides support in the home for diabetes management tasks; Average of items: 1>x>5; higher scores indicate greater frequency of help
Time Frame
At enrollment and approximately 3 months after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 2 to 17 years
newly diagnosed (within the past 12 weeks) with T1D
seeking care at UC Davis
Exclusion Criteria:
- Families will be excluded if the child has severe underlying psychiatric, behavioral or medical conditions which could independently affect parental marital stress
Facility Information:
Facility Name
University of California-Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Behavioral Family Therapy and Type One Diabetes
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