Clinical trial NCT02877680: Strengths-Based Behavioral mHealth App for Parents of Adolescents With Type 1 Diabetes-Pilot Study
Official title: Development and Pilot of a Strengths-Based Behavioral mHealth Intervention to Promote Resilience in Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Strengths-based
Mobile Health (mHealth)
Adolescence
Resilience
Family
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Northwestern University Feinberg School of Medicine
name: United States Department of Agriculture (USDA)
First posted: 2016-08-24
Enrollment: 82
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Type 1 diabetes (T1D) management is particularly challenging during adolescence as responsibility for management begins to shift from parents to youth, and positive family teamwork is critical to achieving optimal diabetes outcomes. Existing behavioral family interventions for T1D are beneficial but have limited potential for translation to clinical practice, and universal preventive approaches designed to explicitly promote existing T1D management strengths are needed. Ultimately, the goal of this line of research is to validate brief, convenient, and helpful tools that families of all adolescents with T1D can use to strengthen positive family teamwork and ultimately promote optimal diabetes health outcomes.

Detailed description: Type 1 diabetes (T1D) is among the most common chronic conditions of childhood and its management is complex and relentless. Adolescents have increased risk for worsening glycemic control, putting them at risk for short- and long-term complications. As responsibility for daily T1D management tasks begins to shift from parents to youth, supportive parent-adolescent teamwork promotes optimal diabetes outcomes. However, adolescents' cognitive development, desire for autonomy, and changing family and social relationships can make adherence to treatment recommendations difficult and strain attempts at parent-adolescent teamwork. This study aims to develop and pilot test a mobile app-based behavioral intervention to facilitate positive, supportive parent-adolescent interactions around T1D management. The proposed study has two parts. First, adolescents with T1D (age 12-17), their parents, and diabetes care providers will be invited to participate in designing a smartphone app that supports parents to recognize, keep track of, and reinforce their adolescents for specific positive T1D-related behaviors, or strengths. Example strengths include asking for help with complicated diabetes tasks, talking to friends about diabetes, and expressing confidence or optimism about T1D management. Intermittently throughout the day, the app will push parents a prompt to report which positive T1D behaviors their adolescent has engaged in. The app will generate weekly summary reports of each adolescent's most frequent strength behaviors, and parents will be reminded via the app to praise their adolescent for those patterns. Second, this intervention will be pilot tested with 82 families; parents will be randomized to an intervention or a control condition. Participants in the intervention condition will use the app for 3-4 months and provide feedback, and control participants will receive usual care and will not use the app. The main goal is to determine how often and in what ways families use the app, whether they like it, and to obtain suggestions for improvement. Trends for impact on important diabetes outcomes, such as quality of parent-adolescent relationships, T1D treatment adherence, and glycemic control will also be evaluated. Data - including questionnaires, adherence data from blood glucose meters, and glycemic control biomarkers from a blood draw - will be collected at baseline and again 3-4 months later. The results of this pilot study will help refine the intervention so that it can be evaluated in a fullscale randomized controlled trial. Ultimately, the goal of this research is to validate brief, convenient, and helpful tools that families of all adolescents with T1D can use to strengthen positive family teamwork and ultimately promote optimal diabetes health outcomes.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 1 diabetes according to American Diabetes Association criteria for at least 6 months
* Treated for type 1 diabetes at Texas Children's Hospital Diabetes Care Center
* Parent and adolescent fluency in English
* Parent has mobile device with data plan

Exclusion Criteria:

* Serious medical, cognitive, or mental health comorbidity in parent or adolescent that would preclude ability to participate

Primary outcomes:
measure: Feasibility of Study Design - Recruitment Rate
timeFrame: Immediately following enrollment (baseline timepoint)
measure: Feasibility of T1Doing Well App - Engagement With App At Least Twice A Week
timeFrame: 3-4 months after enrollment (follow-up timepoint)
measure: Acceptability of T1Doing Well App (Survey)
timeFrame: 3-4 months after baseline (follow-up timepoint)
measure: Acceptability - Number of Participants That Felt The Intervention Was Well-Received
timeFrame: 3-4 months after baseline (follow-up timepoint)
Secondary outcomes:
measure: Adherence to Diabetes Regimen (Objective) - Blood Glucose Monitoring Frequency
timeFrame: 3-4 months after baseline (follow-up timepoint)
measure: Glycemic Control - HbA1c
timeFrame: 3-4 months after baseline (follow-up timepoint)
measure: Diabetes Family Impact - Diabetes Family Impact Scale (DFIS), Parent-report
timeFrame: 3-4 months after baseline (follow-up timepoint)
measure: Family Impact - Pediatric Quality of Life Impact Module (Peds QL-FI), Parent-report
timeFrame: 3-4 months after baseline (follow-up timepoint)
measure: Family Communication - Helping for Health Inventory (HHI), Parent-report
timeFrame: 3-4 months after baseline (follow-up timepoint)
measure: Family Communication - Helping for Health Inventory (HHI), Adolescent-report
timeFrame: 3-4 months after baseline (follow-up timepoint)
measure: Diabetes Family Conflict Scale-Revised (DFCS), Parent-report
timeFrame: 3-4 months after baseline (follow-up timepoint)
measure: Diabetes Family Conflict Scale-Revised (DFCS), Adolescent-report
timeFrame: 3-4 months after baseline (follow-up timepoint)
measure: Problem Areas in Diabetes-Teen (PAID-T), Parent-report
timeFrame: 3-4 months after baseline (follow-up timepoint)
measure: Problem Areas in Diabetes-Teen (PAID-T), Adolescent Self-report
timeFrame: 3-4 months after baseline (follow-up timepoint)
measure: Self-Management - Diabetes Self-Management Profile (DSMP), Parent-report
timeFrame: 3-4 months after baseline (follow-up timepoint)
measure: Self-Management - Diabetes Self-Management Profile (DSMP), Adolescent Self-report
timeFrame: 3-4 months after baseline (follow-up timepoint)
measure: Diabetes Strengths and Resilience Measure (DSTAR), Adolescent Self-report
timeFrame: 3-4 months after baseline (follow-up timepoint)
measure: Adolescent Quality of Life - The MIND-Youth Questionnaire, Adolescent Self-report
timeFrame: 3-4 months after baseline (follow-up timepoint)
measure: Parent-Adolescent Relationship Intervention Process Measure, Adolescent Report
timeFrame: 3-4 months after baseline (follow-up timepoint)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine and Texas Children's Hospital
name: Marisa E Hilliard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hilliard ME, Cao VT, Eshtehardi SS, Minard CG, Saber R, Thompson D, Karaviti LP, Anderson BJ. Type 1 Doing Well: Pilot Feasibility and Acceptability Study of a Strengths-Based mHealth App for Parents of Adolescents with Type 1 Diabetes. Diabetes Technol Ther. 2020 Nov;22(11):835-845. doi: 10.1089/dia.2020.0048. Epub 2020 May 22.
citation: Hilliard ME, Eshtehardi SS, Minard CG, Saber R, Thompson D, Karaviti LP, Rojas Y, Anderson BJ. Strengths-Based Behavioral Intervention for Parents of Adolescents With Type 1 Diabetes Using an mHealth App (Type 1 Doing Well): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2018 Mar 13;7(3):e77. doi: 10.2196/resprot.9147.