EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes

Summary

The EMPoWER Study randomized clinical trial is a strengths-based behavioral intervention delivered to youth with type 1 diabetes (age 10 to 13) and their parents. The purpose of the intervention is to improve glycemic, behavioral, and psychosocial outcomes in youth with diabetes using a multiple systems approach that engages youth, their parents, and diabetes care providers to identify and build youths' diabetes strengths. The primary aim of this study is to assess the intervention impact on glycemic control, adherence, and health-related quality of life (HRQOL). Secondary aims are to evaluate behavioral mediators of intervention impact and to examine intervention dose as a mediator of intervention impact.

Eligibility

For Trial Participants -

Inclusion Criteria:

Youth

* type 1 diabetes diagnosis per ADA criteria for at least 6 months,
* age 10 to 13 years at consent,
* English or Spanish fluency,
* At least one hemoglobin A1c value ≥ 8 % (percent) within the past 12 months
* Patient at one of the participating study sites

Parent/legal guardian of youth

* Age at least 18 years old at time of consent,
* English or Spanish fluency,
* Consistent access to a mobile phone that has texting capabilities and a device with internet access

Exclusion Criteria:

Youth

Being treated for:

* a major serious or acute medical condition or comorbidity (e.g. cancer, cystic fibrosis),
* a major serious psychological or psychiatric condition,
* a major serious developmental condition that would interfere with capacity for informed assent or participation or that would confound outcomes

Parents/legal guardian of youth participant

Being treated for:

* a major serious or acute medical condition or comorbidity (e.g. cancer, cystic fibrosis),
* a major serious psychological or psychiatric condition,
* a major serious developmental condition that would interfere with capacity for informed consent or participation or that would confound outcomes

Other Exclusion Criteria

* Plans to move diabetes care out of participating hospital site within next 6 months,
* Legal guardianship of the youth with diabetes being unclear at the time of screening or recruitment,
* Study team learning of other involvement with the legal system during screening or recruitment

For the Teen Videos:

Inclusion Criteria:

* self-reported type 1 diabetes diagnosis for ≥ 1 year,
* age 14-17 at consent,
* English fluency,
* living in the United States

Exclusion Criteria:

* major psychiatric or developmental disorders in youth or parents that would interfere with capacity for informed consent or participation,
* major medical comorbidities that would confound outcomes (e.g., cancer, cystic fibrosis).

Diabetes Care Provider Participants

Inclusion Criteria:

\- Provider at one of the sites' diabetes care centers

Conditions2

Locations1 site

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