Clinical trial NCT06014879: EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes
Official title: Strengths-Based Multi-Level Behavioral Intervention to Promote Resilience and Self-Management in Youth With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes
youth
adolescent
child
positive psychology
mhealth
ehealth
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Children's National Research Institute
First posted: 2023-08-28
Enrollment: 250
Sex: ALL
Minimum age (years): 10
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For the first phase of this project, all teen participants (up to 40 total) will create videos about living well with type 1 diabetes. The videos will be used in the upcoming randomized clinical trial of the new intervention.

For the randomized control trial, a parallel two group design will be used to evaluate the intervention among n=250 parents and youth dyads assigned to the Type 1 Doing Well intervention condition or the enhanced usual care condition (1:1). All parent and youth dyads are randomized to either the Type 1 Doing Well intervention condition or the enhanced usual care condition. Parents and youth dyads will be in the the study for approximately 12 months.

Providers (up to 20 per site, 40 total) will also be enrolled as participants to deliver the provider conversation intervention to parent and youth dyads randomized to the intervention condition, and to provide data about their experiences.
Primary purpose: TREATMENT

Brief 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.

Detailed description: The goal of the randomized clinical trial (RCT) is to learn if a brief behavioral intervention targeting multiple systems ("Type 1 Doing Well" Program) can improve glycemic, behavioral, and psychosocial outcomes in youth with type 1 diabetes. Youth, age 10 to 13, will enroll with one parent or legal guardian to participate in the study with them. Researchers will compare the Type 1 Doing Well (T1DW) Program arm to the Enhanced Usual Care (EUC; "Diabetes-Related Information and Resources" Program) arm.

Parent-youth dyads in both study arms will provide data (e.g. questionnaires, A1c, medical chart and diabetes device data) at four timepoints throughout the duration of the study. Following baseline data collection, parent-youth dyads will complete an orientation session with study team members to be randomized to their study arm and review study activities. Parent and youth will also be invited to complete a feedback interview on their experience with the program they received.

The intervention will take place during the 6-month intervention period, and participants will be randomly allocated to 1 of two intervention conditions:

1. Parents and youth in the T1DW Program condition (intervention) will use a web-based mobile application to do daily and weekly activities focused on recognizing and reinforcing youths' diabetes strengths. They will also have a conversation with the youth's diabetes provider about what is going well in diabetes care at a routine diabetes appointment.
2. Parents and youth in the EUC Program condition will receive and review 6 monthly diabetes-related information and resources in the form of electronic handouts.

In preparation for the randomized clinical trial of a new behavioral intervention for preteens with type 1 diabetes and their parents, the study is also enrolling adolescents with type 1 diabetes to create videos about living well with type 1 diabetes. The videos will be used in the intervention materials for the randomized clinical trial.

Diabetes care providers at each of the sites will also be enrolled in the study. Provider participants will receive a brief training to deliver the strength-based conversation with parent-youth dyads in the T1DW Program arm, and they will complete study-related questionnaires about their experiences delivering the strengths-based conversation component of the intervention.

Eligibility criteria: 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

Primary outcomes:
measure: Demographic and Medical Information Questionnaire
timeFrame: Baseline
measure: Glycemic Control - HbA1c
timeFrame: Baseline, 6 months, 12 months
measure: Glycemic Control - time-in-range
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Adherence - Self-Care Inventory 2 (SCI-2)
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Health-Related Quality of Life (HRQOL)
timeFrame: Baseline, 3 months, 6 months, and 12 months
Secondary outcomes:
measure: Diabetes Distress
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Diabetes Strength
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Positivity Scale
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Role Overload
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Family Conflict - Diabetes Family Conflict Scale - Revised (DFCS)
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Positive Affect 15a Items
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: PROMIS Short Form Family Relationships 4a Items
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Satisfaction Questionnaire
timeFrame: 3 months, 6 months, and 12 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Marisa Hilliard, PhD
role: PRINCIPAL_INVESTIGATOR
References: