- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02116647
Role of Psychoanalysis in Prevention of Girl Child Maltreatment and Neglect
September 27, 2015 updated by: Macmillan Research Group UK
Role of Psychoanalysis in Prevention of Girl Child Maltreatment and Neglect: A Randomized Controlled Trial
In India, precisely northern states, skewed sex ratios, female feticide and higher child mortality rates for girls have become serious concern.
The female child mortality as a result of son preference have increased during the last several decades .Since families cannot know the sex of the fetus due to Indian government policies, maltreatment and serious neglect has been tools to ensure there are few survivors.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
134
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gujarat
-
Ahmadabad, Gujarat, India
- Sonal Foundation
-
-
Rajasthan
-
Jhunjhunu, Rajasthan, India
- NMP Medical Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Families having girl child before
- High risk families with high expectation of having son
Exclusion Criteria:
- Families having son before
- Relocation and moving out of town during study period
- Not ready to consent for intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
Standard care
|
|
|
Experimental: Psychoanalytic therapy
manualized psychoanalytic psychotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Post Natal Depression
Time Frame: Change from baseline in Edinburgh Postnatal Depression Scale at 6 weeks
|
Change from baseline in Edinburgh Postnatal Depression Scale at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mother-infant interaction
Time Frame: Change from Baseline in Parent/Caregiver Involvement Scale at 6 weeks
|
Change from Baseline in Parent/Caregiver Involvement Scale at 6 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Abuse and neglect outcomes
Time Frame: Upto six weeks reported incidences of abuse and maltreatment
|
Upto six weeks reported incidences of abuse and maltreatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Bharat Chaudhari, MA, Sonal Foundation, India
- Study Chair: Mandy Conlon, MA, Goldington Family Center, UK
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
April 15, 2014
First Submitted That Met QC Criteria
April 15, 2014
First Posted (Estimate)
April 17, 2014
Study Record Updates
Last Update Posted (Estimate)
September 29, 2015
Last Update Submitted That Met QC Criteria
September 27, 2015
Last Verified
July 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- Mac/NMP 1130
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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