Behavioral Family Therapy and Type One Diabetes

NCT ID: NCT03720912

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-22

Study Completion Date

2023-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 The investigators prior work (Loomba-Albrecht and Glaser, unpublished data) suggests that the strongest determinants of glycemic control are factors related to the primary caregiver's involvement in supportive relationships with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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Online Family Education Modules

Patients will receive online family education modules.

Group Type EXPERIMENTAL

Online Learning Modules

Intervention Type BEHAVIORAL

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

Control

Patients will not receive any intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Online Learning Modules

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Nevada, Reno

OTHER

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California-Davis

Sacramento, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39432892 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1303325

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Childhood Diabetes
NCT00804232 UNKNOWN NA
Type 1 Diabetes Telemedicine
NCT03374462 COMPLETED NA