Behavioral Family Therapy and Type One Diabetes

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 The investigators prior work (Loomba-Albrecht and Glaser, unpublished data) suggests that the strongest determinants of glycemic control are factors related to the primary caregiver's involvement in supportive relationships with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

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Behavioral: Online Learning Modules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |