N/A
N=48
Check It! 2.0: Positive Psychology Intervention for Adolescents With Type 1 Diabetes
Type1diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02984709 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Glycemic Control (A1C) — 8.60; 9.35 percentage of glycosylated hemoglobin — p=0.593
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Positive Psychology Intervention (Behavioral); Education (Behavioral)
- Age
- Pediatric · 13+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycemic Control (A1C) |
8.60; 9.35 | 0.593 |
| SECONDARY Positive Affect |
40.6; 42.8 | 0.581 |
| SECONDARY Frequency of Blood Glucose Monitoring |
3.8; 3.2 | 0.206 |
| SECONDARY Diabetes Family Conflict Scale |
30; 36; 23.8; 30.4 | 0.511 |
| SECONDARY Diabetes-Specific Quality of Life |
71; 71 | 0.873 |
| SECONDARY Primary Control Coping |
.18; .20 | 0.603 |
| SECONDARY Secondary Control Coping |
.27; .28 | — |
| SECONDARY Disengagement Coping |
.14; .14 | — |
| SECONDARY Self Care Inventory |
26.6; 25.9; 25.2; 26.0 | — |
Summary
The treatment regimen for type 1 diabetes is complex and demanding, and many adolescents have problems with adherence. The proposed study will pilot test a positive psychology intervention for adolescents with type 1 diabetes aimed at improving adherence to treatment based on feedback from the first iteration of the intervention. The potential benefits include helping adolescents achieve better glycemic control, thereby reducing the health risks and complications associated with diabetes.
Eligibility Criteria
Inclusion Criteria
Adolescents will be eligible if they are:
- between the ages of 13-17;
- have been diagnosed with type 1 diabetes for at least 1 year;
- have no other major health problems;
- are not currently participating in any other intervention studies;
- have a glycosylated hemoglobin level between 7.5 - 12% on date of enrollment;
- are patients of the Eskind Diabetes Clinic
- must read and write in English
- and must live the caregiver that is participating in the study with them
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT02984709). 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.