Behavioral Family Therapy and Type One Diabetes

N/ACompletedNCT03720912

University of California, Davis75 enrolled

Overview

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).

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 The investigators prior work (Loomba-Albrecht and Glaser, unpublished data) suggests that the strongest determinants of glycemic control are factors related to the primary caregiver's involvement in supportive relationships with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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Diabetes Mellitus, Type 1

Interventions

Online Learning ModulesBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

University of California-Davis

Sacramento, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 6, 12, 18, and 24 months

Secondary Outcomes

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)

Time frame: 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

Time frame: 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.

Time frame: 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)

Time frame: At enrollment and approximately 3 months after enrollment

FoH-C Frequency of Help

Data from ClinicalTrials.gov

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