Behavioral Family Therapy and Type One Diabetes

• Sponsor: University of California, Davis (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03720912
• Collaborator: University of Nevada, Reno (Other)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 55.3
• Patients Per Site Per Month: 2.2

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1	Behavioral: Online Learning Modules	N/A

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 The investigators prior work (Loomba-Albrecht and Glaser, unpublished data) suggests that the strongest determinants of glycemic control are factors related to the primary caregiver's involvement in supportive relationships with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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (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.
• Primary Purpose: Health Services Research
• Official Title: Effect of Behavioral Family Therapy on Glycemic Control in Children With Type One Diabetes
• Actual Study Start Date: Oct 22, 2018
• Actual Primary Completion Date: Sep 1, 2021
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Online Family Education Modules Patients will receive online family education modules.	Behavioral: Online Learning Modules; The modules will include information about common family management skills: social support, problem solving, communication, and supportive behavior change strategies.
No Intervention: Control Patients will not receive any intervention.

Outcome Measures

Primary Outcome Measures

1. Change in HbA1c Level [6, 12, 18, and 24 months]

   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

1. Behavioral Affect Rating [At enrollment and approximately 3 months after enrollment]

   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)

2. Child Perception of Interparental Conflict (CPIC) [At enrollment and approximately 3 months after enrollment]

   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

3. Family Assessment Device-General Functioning Subscale [At enrollment and approximately 3 months after enrollment]

   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.

4. Patient-Reported Outcomes Information System- Short Forms (PROMIS) [At enrollment and approximately 3 months after enrollment]

   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)

5. FoH-C Frequency of Help [At enrollment and approximately 3 months after enrollment]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California-Davis	Sacramento	California	United States	95817

Sponsors and Collaborators

• University of California, Davis
• University of Nevada, Reno

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT03720912
• Other Study ID Numbers: 1303325
• First Posted: Oct 25, 2018
• Last Update Posted: Sep 22, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Sep 22, 2021