Phase 3
N=60
STEP: Social Support To Empower Parents
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00480493 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcome: Primary: Maternal Confidence Scale — 38; 37 units on a scale — p=0.468
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- STEP (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Massachusetts, Worcester
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maternal Confidence Scale |
38; 37 | 0.468 |
| PRIMARY Parent Concern |
149; 154 | 0.634 |
| PRIMARY Worry |
27; 27 | 0.430 |
Summary
This RCT intervention provides parental social support (informational, affirmational, and emotional) using parent mentors (experienced in the management of the chronic illness) for mothers and fathers of young children newly diagnosed with type 1 diabetes. The parent mentors provide both home visits and phone call support over the course of the first year after diagnosis. The hypothesis is that newly diagnosed parents who receive the intervention will perceive less parental concern and worry, less negative impact on the family, more perceived confidence and social support compared to those mothers and fathers not receiving the intervention.
Eligibility Criteria
Inclusion Criteria
- Mothers and fathers of children 12 years and younger with type 1 diabetes
Data sourced from ClinicalTrials.gov (NCT00480493). 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.