Trial Outcomes & Findings for STEP: Social Support To Empower Parents (NCT NCT00480493)

NCT ID: NCT00480493

Last Updated: 2012-07-30

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 60 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2012-07-30

Participant Flow

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).

Participant milestones

Measure	Parent Mentor Contact Parent mentor provides face-to-face, phone and/or e-mail social support	Control Arm Parent in this group receives parent contact phone number that they can call for parent support
Overall Study STARTED	32	28
Overall Study Randomized	32	28
Overall Study COMPLETED	30	21
Overall Study NOT COMPLETED	2	7

Reasons for withdrawal

Measure	Parent Mentor Contact Parent mentor provides face-to-face, phone and/or e-mail social support	Control Arm Parent in this group receives parent contact phone number that they can call for parent support
Overall Study moved	2	7

Baseline Characteristics

STEP: Social Support To Empower Parents

Baseline characteristics by cohort

Measure	Parent Mentor Contact n=32 Participants Parent mentor provides face-to-face, phone and/or e-mail social support	Control Arm n=28 Participants Parent in this group receives parent contact phone number that they can call for parent support	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	28 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	36 years STANDARD_DEVIATION 6.5 • n=5 Participants	36 years STANDARD_DEVIATION 6 • n=7 Participants	36 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	28 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	28 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: All participants with data were analyzed

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)

Outcome measures

Measure	Parent Contact Control Arm n=28 Participants Parent contact control arm had a phone number only to call an experienced parent raising a child with type 1 diabetes to discuss support. The experienced parent contact did not initiate the contact.	Parent Mentor Experimental Arm n=32 Participants Parent mentor experimental arm had an assigned experienced parent raising a child with type 1 diabetes. The experienced parent mentor contacted the parent and negotiated the intervention dose, depending on need.
Maternal Confidence Scale	38 units on a scale Standard Deviation 7	37 units on a scale Standard Deviation 10

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Parent Contact Control Arm n=28 Participants Parent contact control arm had a phone number only to call an experienced parent raising a child with type 1 diabetes to discuss support. The experienced parent contact did not initiate the contact.	Parent Mentor Experimental Arm n=32 Participants Parent mentor experimental arm had an assigned experienced parent raising a child with type 1 diabetes. The experienced parent mentor contacted the parent and negotiated the intervention dose, depending on need.
Parent Concern	149 units on a scale Standard Deviation 38	154 units on a scale Standard Deviation 45

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Parent Contact Control Arm n=28 Participants Parent contact control arm had a phone number only to call an experienced parent raising a child with type 1 diabetes to discuss support. The experienced parent contact did not initiate the contact.	Parent Mentor Experimental Arm n=32 Participants Parent mentor experimental arm had an assigned experienced parent raising a child with type 1 diabetes. The experienced parent mentor contacted the parent and negotiated the intervention dose, depending on need.
Worry	27 units on a scale Standard Deviation 7	27 units on a scale Standard Deviation 7.5

Adverse Events

Parent Mentor Contact

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Susan Sullivan-Bolyai

University of Massachusetts, Worcester

Phone: 508-856-4185

Email: susan.sullivan-bolyai@umassmed.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place