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STEP: Social Support To Empower Parents (STEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00480493
Recruitment Status : Completed
First Posted : May 31, 2007
Results First Posted : July 30, 2012
Last Update Posted : July 30, 2012
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Type 1 Diabetes
Intervention: Behavioral: STEP

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Parent Mentor Contact   Control Arm
STARTED   32   28 
Randomized   32   28 
COMPLETED   30   21 
NOT COMPLETED   2   7 
moved                2                7 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   Parent Mentor Contact   Control Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   28   60 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   32   28   60 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 36  (6.5)   36  (6)   36  (6) 
Gender 
[Units: Participants]
     
Female   32   28   60 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   32   28   60 


  Outcome Measures

1.  Primary:   Maternal Confidence Scale   [ Time Frame: 12 months ]

2.  Primary:   Parent Concern   [ Time Frame: 12 months ]

3.  Primary:   Worry   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
We did not have enough parents recruited to look at structural equation modeling.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Susan Sullivan-Bolyai
Organization: University of Massachusetts, Worcester
phone: 508-856-4185
e-mail: susan.sullivan-bolyai@umassmed.edu



Responsible Party: Susan Sullivan-Bolyai, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00480493     History of Changes
Other Study ID Numbers: 1R15NR008391-01 ( U.S. NIH Grant/Contract )
First Submitted: May 29, 2007
First Posted: May 31, 2007
Results First Submitted: November 3, 2011
Results First Posted: July 30, 2012
Last Update Posted: July 30, 2012