Type 1 Diabetes
Conditions
Brief 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.
Interventions
BEHAVIORALSTEP
Experimental: Minutes of parent mentor-parent participant interactions Control: Minutes of parent contact-parent participant interactions
Sponsors
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Mothers and fathers of children 12 years and younger with type 1 diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Confidence Scale | 12 months | Maternal confidence in managing child with type 1 diabetes . Higher total scores (10 questions, minimum score of 0, maximum score of 50) mean a better outcome (greater maternal confidence) |
| Parent Concern | 12 months | Parent concern in managing child with type 1 diabetes. Higher total scores (58 questions, minimum score is 58; maximum score is 255) means more worry with managing child's diabetes care. |
| Worry | 12 months | Parent worry in managing child's care. Higher total scores (11 questions, minimum score is 11, maximum score is 44) indicate more parental worry |
Countries
United States
Participant flow
Recruitment details
Mothers recruited from 2 pediatric diabetes clinics in NE US,randomized 1:1 to either E or C. Of 118 mothers approached, 30 declined due to hectic schedules or had enough support; 28 (24%) passive no. 60 mothers completed the consent and baseline data, randomized to either E (32) or C (28).
Participants by arm
| Arm | Count |
|---|---|
| Parent Mentor Contact Parent mentor provides face-to-face, phone and/or e-mail social support | 32 |
| Control Arm Parent in this group receives parent contact phone number that they can call for parent support | 28 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | moved | 2 | 7 |
Baseline characteristics
| Characteristic | Control Arm | Parent Mentor Contact | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 32 Participants | 60 Participants |
| Age Continuous | 36 years STANDARD_DEVIATION 6 | 36 years STANDARD_DEVIATION 6.5 | 36 years STANDARD_DEVIATION 6 |
| Region of Enrollment United States | 28 participants | 32 participants | 60 participants |
| Sex: Female, Male Female | 28 Participants | 32 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 28 |
| serious Total, serious adverse events | 0 / 32 | 0 / 28 |
Outcome results
Primary
Maternal Confidence Scale
Maternal confidence in managing child with type 1 diabetes . Higher total scores (10 questions, minimum score of 0, maximum score of 50) mean a better outcome (greater maternal confidence)
Time frame: 12 months
Population: All participants with data were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parent Contact Control Arm | Maternal Confidence Scale | 38 units on a scale | Standard Deviation 7 |
| Parent Mentor Experimental Arm | Maternal Confidence Scale | 37 units on a scale | Standard Deviation 10 |
Comparison: A 2 sided t-test was used to determine if the change in Confidence score was significantly different between the groups.p-value: 0.46895% CI: [-4.32, 9.24]t-test, 2 sided
Primary
Parent Concern
Parent concern in managing child with type 1 diabetes. Higher total scores (58 questions, minimum score is 58; maximum score is 255) means more worry with managing child's diabetes care.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parent Contact Control Arm | Parent Concern | 149 units on a scale | Standard Deviation 38 |
| Parent Mentor Experimental Arm | Parent Concern | 154 units on a scale | Standard Deviation 45 |
Comparison: A 2 sided t-test was used to determine if there were significant differences in Concern between the two groups at 12 months.p-value: 0.63495% CI: [-15.47, 25.11]t-test, 2 sided
Primary
Worry
Parent worry in managing child's care. Higher total scores (11 questions, minimum score is 11, maximum score is 44) indicate more parental worry
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parent Contact Control Arm | Worry | 27 units on a scale | Standard Deviation 7 |
| Parent Mentor Experimental Arm | Worry | 27 units on a scale | Standard Deviation 7.5 |
Comparison: The difference in the Worry score at 12 months was compared between the groups using a 2 sided t-test.p-value: 0.4395% CI: [-8.76, 3.8]t-test, 2 sided