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Study Overview

Title:
The Comprehensive Impacts of Receiving Cleft Surgery
Study ID:
RIDIE-STUDY-ID-5a746bc0ec10c
Initial Registration Date:
02/02/2018
Last Update Date:
01/26/2018
Study Status:
Ongoing
Location(s):
India
Abstract:
Cleft palate and cleft lip are birth defects in which the newborn has an aperture in the roof of the mouth and/or the upper lip. Left untreated, a cleft can lead to speech impediments, problems with eating, and an unsightly facial deformity. A sequence of simple, common surgical procedures can restore function with minimal scarring, but the social, educational, physical, and psychological impacts of receiving this surgery have not been rigorously evaluated. This study uses a difference-in-difference identification strategy with a household level fixed effect to compare teenage life outcomes with treated cleft lip and palate to the life outcomes of their nearest-age sibling, and then compares that difference to the difference between the teenage life outcomes of untreated cleft patients and those of their own nearest-age sibling. This strategy allows estimation of the impact of being born with a cleft, as well as the impact of receiving a full or partial course of reparative surgeries early in life. Key outcomes include measures of social integration, education and learning, psychological well-being, behavioral problems, levels of parental support, , and physical health.
Categories:
Health, Nutrition, and Population
Additional Keywords:
Cleft Palate, Public Health, Reparative Surgery, India
Secondary ID Number(s):

Principal Investigator(s)

Name of First PI:
Bruce Wydick
Affiliation:
University of San Francisco
Name of Second PI:
Affiliation:

Study Sponsor

Funding Proposal:

Research Partner

Name of Partner Institution:
Mahatma Gandhi College of Medicine
Type of Organization:
Research institute/University
Website:
http://www.mgmmedicalcollege.org/
Location:
India
Intervention

Intervention Overview

Intervention:
Cleft palate and cleft lip surgery, performed on children either at birth or in teenage years.
Theory of Change:
Left untreated, a cleft can lead to speech impediments, problems with eating, and an unsightly facial deformity. Cleft palate surgery allows patients to speak more clearly, to better process food, and reduces the stigma of the facial deformity. We believe better processing of food, especially in infancy, allows for better nutrition and subsequent physical strength and cognitive ability. The repair of the facial deformity should increase psychological health, social inclusion, attendance and school (which may be reduced by bullying), learning, and education.
Multiple Treatment Arms Evaluated?
No

Implementing Agency

Name of Organization:
Operation Smile
Type of Organization:
NGO (International)

Program Funder

Name of Organization:
Broad-based public funding from private individuals
Type of Organization:
Other

Intervention Timing

Intervention or Program Started at time of Registration?
Yes
Start Date:
01/26/1990
End Date:
Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:
Difference in difference/fixed effects
Other (not Listed) Method:
Additional Evaluation Method (If Any):
Other (not Listed) Method:

Method Details

Details of Evaluation Approach:
We will use a difference-in-difference approach with household fixed effects that compares life outcomes from operated cleft children to their siblings and compares this difference to the difference between upoperated cleft children to their siblings. The sample of those who will make up our treatment group will come from a roster of 282 cleft patients that our partner organization, Operation Smile, previously treated in West Bengal, India between 2004-­?-2015. Other treated patients will be those who have been operated on, but who appear at screening camps for further surgeries. Our control group will include siblings of cleft children without the cleft deformity. (See attached Pre-Analysis Plan for additional details.)
Outcomes (Endpoints):
Key outcomes of interest include a range of indicators that measure social integration, education and learning, psychological well-being, behavioral problems, levels of parental support, and physical health. (See attached Pre-Analysis Plan for additional details.)
Measurement:
Variables will be taken from survey data. Aside from the data collected in the parent survey on cleft condition, surgical history, and socio-economic variables that describe the household, we will treat data collected from the parent surveys as one separate dataset on which we can test our hypotheses, and we will treat the patient/sibling survey data as another separate dataset that we will use to test our hypotheses. Indices will be constructed from an index suggested in Kling et al. (2007), which calculates a simple average of normalized variables. (See attached Pre-Analysis Plan for additional details.)
Unit of Analysis:
Main unit of analysis is the child relative to outcomes of siblings.
Hypotheses:
See our attached Pre-Analysis Plan for additional details about hypotheses to be tested. We will test specific hypotheses about the impact of past cleft surgery on four families of outcomes: 1. Physical and Health Outcomes including speech clarity and general health; 2. Social Inclusion, Family Relationships, and Behavior; 3. Psychological Outcomes such as depression, self-esteem, aspirations, and hope; 4. Cognition, Education, and Learning.
Unit of Intervention or Assignment:
At the level of the individual child.
Number of Clusters in Sample:
Number of Individuals in Sample:
875
Size of Treatment, Control, or Comparison Subsamples:
250 treatment, 625 Control

Supplementary Files

Analysis Plan:
Wydick_Pre-Analysis Plan_CleftSurgery_2018-1-26.pdf
Other Documents:
Data

Outcomes Data

Description:
Primary survey data administered by research team in India.
Data Already Collected?
Yes
Survey Name:
India Cleft Palate Survey (Our own primary data collection)
Data Previously Used?
No
Data Access:
Not restricted - access with no requirements or minimal requirements (e.g. web registration)
Data Obtained by the Study Researchers?
Yes
Data Approval Process:
Approval Status:

Treatment Assignment Data

Participation or Assignment Information:
Yes
Description:
Data Obtained by the Study Researchers?
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Data Analysis

Data Analysis Status:
No

Study Materials

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Registration Category

Registration Category:
Prospective, Category 3: Data for measuring impacts have been obtained/collected by the research team but analysis for this evaluation has not started
Completion

Completion Overview

Intervention Completion Date:
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Findings

Preliminary Report:
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Paper:
Paper Summary:
Paper Citation:

Data Availability

Data Availability (Primary Data):
Date of Data Availability:
Data URL or Contact:
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Other Materials

Survey:
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Program Files:
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External Link:
External Link Description:
Description of Changes:

Study Stopped

Date:
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