Behavioral Family Therapy and Type One Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Effect of Behavioral Family Therapy on Glycemic Control in Children With Type One Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03720912
• Other study ID #: 1303325
• Status: Completed
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 The investigators prior work (Loomba-Albrecht and Glaser, unpublished data) suggests that the strongest determinants of glycemic control are factors related to the primary caregiver's involvement in supportive relationships with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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 1, 2023
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Behavioral:
• Online Learning Modules
The modules will include information about common family management skills: social support, problem solving, communication, and supportive behavior change strategies.

Locations

Country	Name	City	State
United States	University of California-Davis	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	University of Nevada, Reno

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6, 12, 18, and 24 months
Secondary	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)	At enrollment and approximately 3 months after enrollment
Secondary	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	At enrollment and approximately 3 months after enrollment
Secondary	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.	At enrollment and approximately 3 months after enrollment
Secondary	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)	At enrollment and approximately 3 months after enrollment
Secondary	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	At enrollment and approximately 3 months after enrollment