Diabetes Mellitus, Type 1
Conditions
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 The investigators prior work (Loomba-Albrecht and Glaser, unpublished data) suggests that the strongest determinants of glycemic control are factors related to the primary caregiver's involvement in supportive relationships with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.
Interventions
BEHAVIORALOnline Learning Modules
The modules will include information about common family management skills: social support, problem solving, communication, and supportive behavior change strategies.
Sponsors
University of Nevada, Reno
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
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.
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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. |
| 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) |
| 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 |
Countries
United States
Outcome results
None listed