Strengths-Based Behavioral mHealth App for Parents of Adolescents With Type 1 Diabetes-Pilot Study

NCT02877680 | Completed Results

• 2 other identifiers: H-373111R21DK107951
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Strengths-based; Mobile Health (mHealth); Adolescence; Resilience; Family

Outcome Measures

Primary Outcomes (4)

• Feasibility of Study Design - Recruitment Rate

  Recruitment data measured by percent of recruited families that enrolled in study.

  Immediately following enrollment (baseline timepoint)

• Feasibility of T1Doing Well App - Engagement With App At Least Twice A Week

  Feasibility of the app measured by percentage of participants that engaged with or used the app at least twice a week during the intervention period.

  3-4 months after enrollment (follow-up timepoint)

• Acceptability of T1Doing Well App (Survey)

  Participants in the intervention arm completed the Usefulness, Satisfaction, and Ease of Use Questionnaire (USE), a measure of the users' perceived usefulness of, satisfaction with, and ease of use of a particular technology. The item scale ranges from the minimum to maximum possible score is 1-7, with a higher score representing a better outcome. Acceptability measured as percentage of participants who selected a score of at least 4 (out of 7) on the item "I am satisfied with it," indicating it was at least somewhat acceptable.

  3-4 months after baseline (follow-up timepoint)

• Acceptability - Number of Participants That Felt The Intervention Was Well-Received

  The number of participants that felt the intervention was well-received was collected for Adolescents and Parents. To determine if the intervention was well-received, verbal responses from qualitative interviews with were coded for types of participant feedback by the study team. We coded these data qualitatively and classified them as Positive, Negative, or Neutral. Positive responses indicate the intervention was well-received.

  3-4 months after baseline (follow-up timepoint)

Secondary Outcomes (15)

• Adherence to Diabetes Regimen (Objective) - Blood Glucose Monitoring Frequency

  3-4 months after baseline (follow-up timepoint)

• Glycemic Control - HbA1c

  3-4 months after baseline (follow-up timepoint)

• Diabetes Family Impact - Diabetes Family Impact Scale (DFIS), Parent-report

  3-4 months after baseline (follow-up timepoint)

• Family Impact - Pediatric Quality of Life Impact Module (Peds QL-FI), Parent-report

  3-4 months after baseline (follow-up timepoint)

• Family Communication - Helping for Health Inventory (HHI), Parent-report

  3-4 months after baseline (follow-up timepoint)

Study Arms (2)

Intervention

EXPERIMENTAL

Smartphone app for parents to track adolescents' strength behaviors related to living with and managing type 1 diabetes, including regular feedback to parents and training about how to recognize and reinforce positive behaviors in teens.

Behavioral: T1Doing Well

Usual Care

NO INTERVENTION

Usual diabetes care and study-related data collection, without use of app during the study period. They will be offered an opportunity to try the app and share their feedback with the study team after completing follow-up data collection.

Interventions

T1Doing Well BEHAVIORAL

Strengths-based mobile health (mHealth) app for parents of adolescents with type 1 diabetes, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors

Intervention

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Northwestern University Feinberg School of Medicine: collaborator
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 32379496 DERIVED

• 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.

  PMID: 29535081 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Marisa Hilliard, Associate Professor of Pediatrics
• Organization: Baylor College of Medicine

marisa.hilliard@bcm.edu

832-824-7209

Study Officials

• Marisa E Hilliard, PhD

  Baylor College of Medicine and Texas Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 24, 2016
• Study Start: July 31, 2017
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: September 24, 2020
• Results First Posted: June 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)