N/A
Completed N=80
Strengths-Based Behavioral mHealth App for Parents of Adolescents With Type 1 Diabetes-Pilot Study
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT02877680 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Feasibility of Study Design - Recruitment Rate — 84 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Study Design - Recruitment Rate |
84 | — |
| PRIMARY Feasibility of T1Doing Well App - Engagement With App At Least Twice A Week |
50 | — |
| PRIMARY Acceptability of T1Doing Well App (Survey) |
48 | — |
| PRIMARY Acceptability - Number of Participants That Felt The Intervention Was Well-Received |
35; 38 | — |
| SECONDARY Adherence to Diabetes Regimen (Objective) - Blood Glucose Monitoring Frequency |
2.6; 3.1 | — |
| SECONDARY Glycemic Control - HbA1c |
8.7; 8.4 | — |
| SECONDARY Diabetes Family Impact - Diabetes Family Impact Scale (DFIS), Parent-report |
20.7; 19.1 | — |
| SECONDARY Family Impact - Pediatric Quality of Life Impact Module (Peds QL-FI), Parent-report |
82.6; 84.5 | — |
| SECONDARY Family Communication - Helping for Health Inventory (HHI), Parent-report |
40.0; 40.0 | — |
| SECONDARY Family Communication - Helping for Health Inventory (HHI), Adolescent-report |
37.9; 41.4 | — |
| SECONDARY Diabetes Family Conflict Scale-Revised (DFCS), Parent-report |
25.4; 24.5 | — |
| SECONDARY Diabetes Family Conflict Scale-Revised (DFCS), Adolescent-report |
23.9; 25.0 | — |
| SECONDARY Problem Areas in Diabetes-Teen (PAID-T), Parent-report |
77.6; 71.0 | — |
| SECONDARY Problem Areas in Diabetes-Teen (PAID-T), Adolescent Self-report |
65.0; 65.2 | — |
| SECONDARY Self-Management - Diabetes Self-Management Profile (DSMP), Parent-report |
53.4; 53.0 | — |
| SECONDARY Self-Management - Diabetes Self-Management Profile (DSMP), Adolescent Self-report |
66.6; 68.4 | — |
| SECONDARY Diabetes Strengths and Resilience Measure (DSTAR), Adolescent Self-report |
37.7; 35.1 | — |
| SECONDARY Adolescent Quality of Life - The MIND-Youth Questionnaire, Adolescent Self-report |
72.2; 68.4 | — |
| SECONDARY Parent-Adolescent Relationship Intervention Process Measure, Adolescent Report |
.0012; .0045 | — |
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
Data sourced from ClinicalTrials.gov (NCT02877680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.