N/A
Completed N=172
Diabetes Strengths Study - Pilot of Provider-delivered Strengths-based Intervention
Source: ClinicalTrials.gov NCT02510664 ↗Enrolled (actual)
172
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Feasibility of Study Design — 84; 84 Participants
Summary
The purpose of this study is to determine whether a newly developed intervention is feasible and acceptable to adolescents with type 1 diabetes and their families and diabetes care providers, and to evaluate trends in whether the intervention impacts important diabetes outcomes. The intervention involves diabetes care providers discussing and reinforcing individuals' and families' diabetes management strengths during routine, outpatient diabetes care appointments.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Study Design |
60; 60; 4 | — |
| PRIMARY Acceptability: Number of Participants That Felt the Intervention Was Well-Received |
46; 44; 4; 0; 0; 0 | — |
| SECONDARY Diabetes Strengths |
38.1; 39.7 | — |
| SECONDARY Diabetes Self-Management Profile - Parent-report |
55.2; 56.9 | — |
| SECONDARY Diabetes Self-Management Profile - Adolescent-report |
56.9 | — |
| SECONDARY Diabetes Regimen Adherence (Blood Glucose Monitoring Frequency) |
3.64 | — |
| SECONDARY Glycemic Control |
8.54 | — |
| SECONDARY Problem Areas in Diabetes - Teen |
61.6 | — |
| SECONDARY Diabetes Burden - Problem Areas in Diabetes - Parent-report |
64.6 | — |
| SECONDARY Diabetes-related Family Conflict (Parent-report) |
24.9 | — |
| SECONDARY Diabetes-related Family Conflict (Adolescent Report) |
24.3 | — |
| SECONDARY Healthcare Satisfaction - PedsQL Healthcare Satisfaction Parent-report |
96.1 | — |
| SECONDARY Adolescent-provider Relationship - Adolescent-report |
8.5 | — |
| SECONDARY Provider-family Relationship, Provider-report |
9.1 | — |
Eligibility Criteria
Inclusion Criteria
- At least one parent of each adolescent, self-identified as the primary caregiver most involved in diabetes care, will also be enrolled with each adolescent participant. When present, secondary caregivers involved in diabetes management will be invited (not required) to participate.
- Youth type 1 diabetes diagnosis for at least 12 months, to allow ample opportunity for adjustment to diabetes management
- Youth and parent fluency in written and spoken English because assessment measures are not available in other languages.
Exclusion Criteria
(1) Presence of a serious mental illness or developmental disability in youth or parent that would impede participation would exclude eligibility.
Data sourced from ClinicalTrials.gov (NCT02510664). 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.