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Completed

NCT Number: NCT03720912

Behavioral Family Therapy and Type One Diabetes

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).

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California-Davis

Sacramento, California, 95817, United States

About this study

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 The investigators prior work (Loomba-Albrecht and Glaser, unpublished data) suggests that the strongest determinants of glycemic control are factors related to the primary caregiver's involvement in supportive relationships with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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Online Learning Modules

Behavioral

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

Primary outcomes

  1. Change in HbA1c Level

    Time frame: 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 outcomes

  1. Behavioral Affect Rating

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • University of Nevada, Reno

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Oct 25, 2018
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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