Family Intervention for Black Teens With Type 1 Diabetes

ConditionsType 1 Diabetes Family Relations

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age10-14

SponsorWayne State University

About this trial

The purpose of this study is to conduct a multicenter, randomized effectiveness trial of The 3Ms 2.0 compared to an educational control condition for improving adolescent glycemic control and diabetes-related family relationships and reducing primary caregiver diabetes-related distress among Black adolescents with type 1 diabetes (T1D) and their primary caregivers. The proposed study would develop and test The 3Ms 2.0 adapted intervention when delivered using a mobile health approach (accessed via parents' cell phone). The intervention will also include new family intervention content (videoclips and text messages).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 10 years, 0 months - 14 years, 11 months

Diagnosed with Type 1 diabetes

Diagnosed for at least 6 months

Black

Disqualifiers

Mental health conditions that might compromise data integrity (e.g., developmental delay, schizophrenia, psychosis, current suicidality, homicidality)

Co-morbid medical condition resulting in atypical diabetes management (e.g., cystic fibrosis)

Inability to speak or read English

Child is in out-of-home placement

Trial design

Design model

Parallel

Treatments tested in this trial

The 3Ms 2.0 Intervention
Behavioral
The 3Ms is a culturally tailored, mHealth intervention for primary caregivers of Black adolescents with T1D focused on promoting daily parental monitoring of adolescent diabetes care and delivered via an Internet platform, Computer Intervention Authoring System (CIAS). The intervention content is based on the Information-Motivation-Behavioral Skills (IMB) model. Caregivers randomized to The 3Ms receive 3 sessions. The caregiver is guided through each session by an interactive and emotive three-dimensional narrator that reads and speaks aloud. Additional intervention content includes brief videoclips to provide skills demonstrations of supportive parenting practices related to diabetes care and text message reminders. Each session is no more than 20 minutes in length. The intervention is delivered over a three-month window, with the two follow-up sessions available to be accessed by the caregiver at one-month intervals after completion of the initial session.
Educational Attention Control (EAC)
Behavioral
The EAC intervention consists of three sessions delivered in an mHealth format via the CIAS internet platform over three months, with access for a maximum of six months. EAC provides structured information on topics of interest to caregivers of adolescents with T1D such as travelling with diabetes, or emergency preparedness for persons with diabetes. All participants receive their standard medical care.

Treatment groups

216 Participants

are divided into 2 treatment groups

Group A: Educational Attention Control (EAC) + Standard Medical CareActive comparator 1 intervention

Group B: The 3Ms 2.0 Intervention + Standard Medical CareExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Glycemic Control

Hemoglobin A1c (HbA1c)

Time frame

Baseline, 3 months, 6 months, and 12 months

Secondary outcomes

Caregiver Diabetes Distress

Parent Problem Areas in Diabetes (P-PAID). The questionnaire's items are rated on a scale from 1 (not a problem) to 6 (serious problem). Higher scores reflect more diabetes distress

Time frame

Baseline, 3 months, 6 months, and 12 months

Diabetes-Specific Family Conflict

Diabetes Family Conflict Scale-Short Form (DFCS-SF). The questionnaire's items are rated on a scale from 1 (almost never) to 3 (almost always). Higher scores reflect more family conflict

Time frame

Baseline, 3 months, 6 months, and 12 months

Diabetes-Specific Parental Monitoring

Parental Monitoring of Diabetes Care-Revised (PMDC-R). The questionnaire's items are rated from 1 to 5, with higher scores reflecting higher parental monitoring

Time frame

Baseline, 3 months, 6 months and 12 months

Diabetes-Specific Family Support

Diabetes Social Support Questionnaire-Family (DSSQ-Family). Items reflecting frequency of support are rated from 0 (never) to 5 (at least once a day). Items reflecting helpfulness of support are rated from 0(not at all) to 2 (very). Higher scores reflect more frequent family support and more helpful family support

Time frame

Baseline, 3 months, 6 months and 12 months

Other outcomes

Illness Management

Diabetes Management Scale (DMS). The questionnaire's items are rated from 0 to 100. Higher scores reflect higher levels of diabetes care completion

Time frame

Baseline, 3 months, 6 months, and 12 months

Intervention Satisfaction

Exit interviews will be conducted to obtain caregiver perspectives regarding satisfaction with intervention content, delivery mode and dose using semi-structured interview guides.

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wayne State University

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Source ClinicalTrials.gov

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