Behavioral Family Therapy and Type One Diabetes

NCT03720912 | Completed

• 1 other identifier: 1303325
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Behavioral Affect Rating

  At enrollment and approximately 3 months after enrollment

• Child Perception of Interparental Conflict (CPIC)

  At enrollment and approximately 3 months after enrollment

• Family Assessment Device-General Functioning Subscale

  At enrollment and approximately 3 months after enrollment

• Patient-Reported Outcomes Information System- Short Forms (PROMIS)

  At enrollment and approximately 3 months after enrollment

• FoH-C Frequency of Help

  At enrollment and approximately 3 months after enrollment

Study Arms (2)

Online Family Education Modules

EXPERIMENTAL

Patients will receive online family education modules.

Behavioral: Online Learning Modules

Control

NO INTERVENTION

Patients will not receive any intervention.

Interventions

Online Learning Modules BEHAVIORAL

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

Online Family Education Modules

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age 2 to 17 years
• newly diagnosed (within the past 12 weeks) with T1D
• seeking care at UC Davis

You may not qualify if:

• \- Families will be excluded if the child has severe underlying psychiatric, behavioral or medical conditions which could independently affect parental marital stress

Sponsors & Collaborators

• University of California, Davis: lead
• University of Nevada, Reno: collaborator

Study Sites (1)

University of California-Davis

Sacramento, California, 95817, United States

Location

Related Publications (1)

• Hughes Lansing A, Cohen LB, Glaser NS, Loomba LA. Feasibility and Acceptability of a Self-Guided Digital Family Skills Management Intervention for Children Newly Diagnosed With Type 1 Diabetes: Pilot Randomized Controlled Trial. JMIR Form Res. 2024 Oct 21;8:e59246. doi: 10.2196/59246.

  PMID: 39432892 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 25, 2018
• Study Start: October 22, 2018
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)