Family Intervention for Black Teens With Type 1 Diabetes

(3Ms Trial)

Recruiting at 3 trial locations

Overseen By Jillian T Sjostrom, B.S.

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Wayne State University

Disqualifiers: Mental health, Cystic fibrosis, others

No Placebo Group

Trial Summary

What is the purpose of 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).

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment The 3Ms 2.0 Intervention for Black teens with Type 1 Diabetes?

Research suggests that family involvement and support can improve diabetes management in youth, especially in single-parent households. Interventions that enhance collaborative parent involvement, like the TEAM intervention, have shown promise in improving glycemic control and treatment adherence in African American and Latino children with Type 1 Diabetes. ^{1 2 3 4 5}

How is the 3Ms 2.0 treatment different from other treatments for Black teens with Type 1 Diabetes?

The 3Ms 2.0 treatment is unique because it focuses on family intervention, specifically designed for Black teens with Type 1 Diabetes, to reduce parent-child conflict and improve diabetes management. This approach is culturally tailored and emphasizes the role of family support, which is not typically the focus of standard diabetes treatments. ^{1 6 7 8 9}

Research Team

Deborah A Ellis, Ph.D.

Principal Investigator

Wayne State University

Eligibility Criteria

This trial is for Black adolescents with type 1 diabetes and their primary caregivers. Participants should be interested in improving blood sugar control and family relationships related to diabetes management. The study seeks families willing to use mobile health tools like video clips and text messages.

Inclusion Criteria

Black

I have been diagnosed with Type 1 diabetes.

Caregiver ownership of an Internet-enabled device (cell phone, laptop or desktop computer, tablet, etc)

Exclusion Criteria

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

I manage my diabetes differently due to another health condition.

Inability to speak or read English

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive The 3Ms 2.0 intervention or Educational Attention Control over a six-month period

6 months

Sessions delivered via mobile device

Data Collection

Data collected at baseline, 3 months, 6 months, and 12 months post-baseline, including questionnaires and blood samples for HbA1c

12 months

4 data collection points (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

6 months

Treatment Details

Interventions

• The 3Ms 2.0 Intervention (Behavioral Intervention)

Trial Overview The trial is testing 'The 3Ms 2.0 Intervention', a mobile health program designed to help manage type 1 diabetes, against an educational attention control group (EAC). It aims to see if the intervention can better support teens' blood sugar levels and reduce stress for caregivers.

Participant Groups

Group I: The 3Ms 2.0 Intervention + Standard Medical Care Experimental Treatment 1 Intervention

Group II: Educational Attention Control (EAC) + Standard Medical Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials

318

Recruited

111,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Findings from Research

In a study of 71 youth with type 1 diabetes, it was found that African American youth experienced a faster decline in metabolic control compared to White youth shortly after diagnosis, with significant differences in hemoglobin A1c levels observed by 24 months.

The study revealed that living in a single-parent household was a strong predictor of worsening metabolic control, with youth from single-parent families deteriorating almost three times faster than those from two-parent families, highlighting the need for targeted support interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting metabolic control in the first 5 yr after diagnosis for youths with type 1 diabetes: the role of ethnicity and family structure. Frey, MA., Templin, T., Ellis, D., et al.[2022]

Multisystemic therapy (MST) significantly improved metabolic control in adolescents with chronic poor diabetes management, showing a 1.01% decrease at 7 months and a 0.74% decrease at 12 months compared to those receiving only telephone support.

Parents reported better adherence to diabetes management in their adolescents receiving MST, suggesting that this intensive, home-based approach can enhance family involvement and potentially improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multisystemic therapy compared to telephone support for youth with poorly controlled diabetes: findings from a randomized controlled trial. Ellis, DA., Naar-King, S., Chen, X., et al.[2022]

A pilot study involving 17 adolescents with poorly controlled type 1 diabetes showed significant improvements in blood glucose monitoring frequency and glycemic control after a 14-week motivational intervention that included family-based contingency management.

The adolescents' HbA1c levels improved significantly, indicating better diabetes management, which suggests that this multicomponent approach could be effective and warrants further testing in a randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicomponent motivational intervention to improve adherence among adolescents with poorly controlled type 1 diabetes: a pilot study. Stanger, C., Ryan, SR., Delhey, LM., et al.[2022]

A 2-year randomized clinical trial involving 390 families showed that a low-intensity, clinic-integrated behavioral intervention significantly improved glycemic control in youth with type 1 diabetes, particularly in those aged 12 to 14.

The intervention effectively prevented the typical decline in diabetes management during adolescence, suggesting it could be a valuable approach to integrate behavioral support into medical care for diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial. Nansel, TR., Iannotti, RJ., Liu, A.[2022]

The TEAM pilot trial aims to enhance collaborative involvement in Type 1 diabetes management among African American and Latino parents of children aged 5-10, addressing significant health disparities in glycemic outcomes.

This randomized trial will assess the feasibility and acceptability of the TEAM intervention, while also examining its potential impact on children's HbA1c levels, treatment adherence, and overall quality of life compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-support intervention for African American and Latino parents to improve the glycemic control trajectory among school-aged children with type 1 diabetes: A pilot and feasibility protocol. Butler, AM., Hilliard, ME., Fegan-Bohm, K., et al.[2022]

Educational interventions for children with type 1 diabetes effectively improve diabetes knowledge but do not consistently lead to better metabolic control, based on a review of 41 studies published between 1980 and 1999.

Psychosocial interventions, particularly coping skills training and peer support, are beneficial for adolescents in improving their adjustment to diabetes and can sometimes enhance metabolic control, while family interventions help reduce conflicts between parents and children regarding diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for children with diabetes and their families. Grey, M.[2019]

The incidence of Type 1 diabetes (T1D) is increasing among youth, particularly in African-American children under 5, highlighting significant health disparities.

There is a notable gap between the demographics of children with T1D participating in research and those most affected, indicating a need for more inclusive and culturally appropriate study designs in behavioral interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considering Culture: A Review of Pediatric Behavioral Intervention Research in Type 1 Diabetes. Rose, M., Aronow, L., Breen, S., et al.[2019]

A randomized clinical trial involving 67 African American adolescents with type 1 diabetes and their caregivers showed that a brief, computer-delivered motivational intervention significantly increased parents' knowledge about the importance of monitoring their child's diabetes management.

The intervention not only improved parental monitoring practices but also led to significant improvements in glycemic control among adolescents, highlighting its potential efficacy in enhancing diabetes management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Computer-Delivered Intervention to Increase Parental Monitoring in Families of African American Adolescents with Type 1 Diabetes: A Randomized Controlled Trial. Ellis, DA., Idalski Carcone, A., Ondersma, SJ., et al.[2022]

Parenting interventions for caregivers of children with type 1 diabetes significantly reduce psychological distress and depression, as shown in a meta-analysis of 17 randomized controlled trials involving 962 participants.

These interventions also help parents seek positive social support, indicating that structured support can improve the mental well-being of caregivers managing diabetes in their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Parenting Interventions on Psychosocial Adjustment in Parents of Children and Adolescents with Type 1 Diabetes: A Meta-Analysis. Zhao, X., Ai, Z., Chen, Y., et al.[2022]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Predicting metabolic control in the first 5 yr after diagnosis for youths with type 1 diabetes: the role of ethnicity and family structure. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Multisystemic therapy compared to telephone support for youth with poorly controlled diabetes: findings from a randomized controlled trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A multicomponent motivational intervention to improve adherence among adolescents with poorly controlled type 1 diabetes: a pilot study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Peer-support intervention for African American and Latino parents to improve the glycemic control trajectory among school-aged children with type 1 diabetes: A pilot and feasibility protocol. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Interventions for children with diabetes and their families. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Considering Culture: A Review of Pediatric Behavioral Intervention Research in Type 1 Diabetes. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Brief Computer-Delivered Intervention to Increase Parental Monitoring in Families of African American Adolescents with Type 1 Diabetes: A Randomized Controlled Trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The Effectiveness of Parenting Interventions on Psychosocial Adjustment in Parents of Children and Adolescents with Type 1 Diabetes: A Meta-Analysis. [2022]