Effectiveness of “Creating Opportunities for Parents Empowerment” family-centered early intervention program on premature infants and their parents’ occupational performance according to Person-Environment-Occupation Model
This is a double-blind clinical trial in which the premature infants and their parents’ occupational performance will be studied. Inclusion criteria for mothers: fluency in Persian; over 18 years of age; residing in Tehran; had not had another premature infant admitted to the NICU; lack of physical and mental chronic diseases. Inclusion criteria for infants: gestational age of 28 to 37 weeks; birth weight of 1000 to 2500 grams; no chromosomal abnormalities; no severe handicapping conditions; singleton birth; apgar score at 5 minutes more than 7; length of hospitalization be more than one week and less than one month. Exclusion criteria: infant and parents suffering from incurable diseases during the study; discharge before finishing defined protocol in NICU; lack of parental consent to continue participation at any stage and for any reason. Three groups of 20 preterm infants and their parents will participate in this study (control group, intervention group, intervention group with supervision). The 5 steps program of "Creating opportunities for parent empowerment" deliver for two intervention groups from infant hospitalization in the neonatal intensive care unit up to 2 months corrected age. The full implementation of the different stages of intervention will follow in intervention group with supervision during the study. At the end of study, effectiveness of this parental training program on infant occupational performance (motor performance, different aspect of infant development) and parents’ performance (participation in caring of infant, satisfaction of parental role) will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015040521613N1
Registration date:2015-04-10, 1394/01/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-04-10, 1394/01/21
Registrant information
Name
Reihaneh Askary Kachoosangy
Name of organization / entity
Rehabilitation Sciences faculty, Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2297 7794
Email address
askarykachoosangy.r@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-05-05, 1394/02/15
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of “Creating Opportunities for Parents Empowerment” family-centered early intervention program on premature infants and their parents’ occupational performance according to Person-Environment-Occupation Model
Public title
Effect of parent training on premature infants and their parents' performance
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria for mothers: ability to read, write, and speak Persian; over 18 years of age; residing in Tehran; had not had another premature infant admitted to the NICU; lack of physical and mental chronic diseases. Inclusion criteria for infants: gestational age of 28 to 37 weeks; birth weight of 1000 to 2500 grams; no chromosomal abnormalities; no severe handicapping conditions including intraventricular hemorrhage; singleton birth; apgar score at 5 minutes more than 7; no congenital abnormalities; no stage 3 and more of retinopathy of prematurity; length of hospitalization be more than one week and less than one month; informed parental consent. Exclusion criteria: infant suffering from incurable diseases during the study; parent suffering from physical and mental diseases; discharge before finishing defined protocol in NICU; lack of parental consent to continue participation at any stage and for any reason
Age
To 2 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat highway , Tehran, Iran.
City
Tehran
Postal code
Approval date
2015-02-14, 1393/11/25
Ethics committee reference number
105/5536/د/93
Health conditions studied
1
Description of health condition studied
preterm infants
ICD-10 code
P07.3
ICD-10 code description
Other preterm infants
Primary outcomes
1
Description
parentns' satisfaction
Timepoint
after intervention
Method of measurement
COPM
2
Description
motor performance of infant
Timepoint
before and after intervention
Method of measurement
New Ballard and TIMP
3
Description
parents' participation in infant caring
Timepoint
before and after intervention
Method of measurement
The Index of Participation/Hospitalized Infant
Secondary outcomes
empty
Intervention groups
1
Description
Control group: will receive routine interventions of hospital
Category
Other
2
Description
Intervention group: Parents empowerment program will be expressed for each mother about 20 minutes by direct and face to face training by considering number of mothers. At the end of session, about 15 minutes will be considered for question and answer. Training package consist of booklet, work book with pictures, and audio tape that will be given parents at the certain times.
Category
Other
3
Description
Intervention group with supervision: In addition to parents empowerment program will be followed regular by the researcher
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh hospital
Full name of responsible person
Reihaneh Askary Kachoosangy
Street address
Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Narges Shafaroodi
Street address
Occupational therapy department, Rehabilitation Sciences faculty, Iran University of Medical Sciences, Shahnazari St, Mirdamad, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Narges Shafaroodi
Position
faculty member
Other areas of specialty/work
Street address
Occupational therapy department, Rehabilitation Sciences faculty, Iran University of Medical Sciences, Shahnazari St, Mirdamad, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2222 7124
Fax
Email
shafarodi.n@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Nargess Shafaroodi
Position
Ph.D in occupational therapy
Other areas of specialty/work
Street address
Occupational therapy department, Rehabilitation Sciences faculty, Iran University of Medical Sciences, Shahnazari St, Mirdamad, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2222 7124
Fax
Email
shafarodi.n@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Scienecs
Full name of responsible person
Dr. nargess shafaroodi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)