Diabetes Mellitus, Type 1NCT03720912
Behavioral Family Therapy and Type One Diabetes
A study testing Online Learning Modules in people with Diabetes Mellitus, Type 1, run by University of California, Davis at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Online Learning Modules
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2018to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 2 to 17 years
- newly diagnosed (within the past 12 weeks) with T1D
- seeking care at UC Davis
Who cannot join
- Families will be excluded if the child has severe underlying psychiatric, behavioral or medical conditions which could independently affect parental marital stress
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California-Davis
Sacramento, California, 95817
About this study
Official title: Effect of Behavioral Family Therapy on Glycemic Control in Children With 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).
Read the 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 The investigators prior work (Loomba-Albrecht and Glaser, unpublished data) suggests that the strongest determinants of glycemic control are factors related to the primary caregiver's involvement in supportive relationships with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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Online Learning Modules
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Learning ModulesBehavioural
The modules will include information about common family management skills: social support, problem solving, communication, and supportive behavior change strategies.
| Study group | Role | What they receive |
|---|---|---|
| Online Family Education Modules | Experimental | Patients will receive online family education modules. Receives: Behavioral: Online Learning Modules |
| Control | No intervention | Patients will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6, 12, 18, and 24 months
Secondary outcomes (5)
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)
Measured: 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
Measured: 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.
Measured: 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)
Measured: At enrollment and approximately 3 months after enrollment
FoH-C Frequency of Help
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
Measured: At enrollment and approximately 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start22 Oct 2018
- Primary completion1 Sep 2021
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nevada, Reno
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720912
- Sponsor's protocol ID
- 1303325
- Status last verified
- Oct 2023
- First submitted
- 22 Oct 2018
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39432892
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Behavioral Family Therapy on Glycemic Control in Children With Type One Diabetes
- ClinicalTrials.gov ID
- NCT03720912
- Acronym / sponsor ID
- 1303325
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- University of Nevada, Reno
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Family Education Modules | Experimental | Behavioral: Online Learning ModulesPatients will receive online family education modules. |
| Control | No intervention | –Patients will not receive any intervention. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age 2 to 17 years
- newly diagnosed (within the past 12 weeks) with T1D
- seeking care at UC Davis
Key exclusion criteria (1 listed)
- Families will be excluded if the child has severe underlying psychiatric, behavioral or medical conditions which could independently affect parental marital stress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Learning ModulesThe modules will include information about common family management skills: social support, problem solving, communication, and supportive behavior change strategies. | Behavioural | Online Family Education Modules |
Primary outcome
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.
5 secondary outcomes
Behavioral Affect Rating
Time frame: At enrollment and approximately 3 months after enrollment
Child Perception of Interparental Conflict (CPIC)
Time frame: At enrollment and approximately 3 months after enrollment
Family Assessment Device-General Functioning Subscale
Time frame: At enrollment and approximately 3 months after enrollment
Patient-Reported Outcomes Information System- Short Forms (PROMIS)
Time frame: At enrollment and approximately 3 months after enrollment
FoH-C Frequency of Help
Time frame: At enrollment and approximately 3 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 39432892Hughes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Learning Modules in people with Diabetes Mellitus, Type 1, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c Level (time frame: 6, 12, 18, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03720912, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.