Role of Psychoanalysis in Prevention of Girl Child Maltreatment and Neglect

Abuse Neglect Clinical Trial

Official title:

Role of Psychoanalysis in Prevention of Girl Child Maltreatment and Neglect: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116647
• Other study ID #: Mac/NMP 1130
• Status: Completed
• Phase: N/A
• First received: April 15, 2014
• Last updated: September 27, 2015
• Start date: November 2012
• Est. completion date: November 2013

Study information

• Verified date: July 2014
• Source: Macmillan Research Group UK
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: November 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Abuse Neglect
• Social; Deprivation, Maltreatment Syndrome (Infant or Child)

Intervention

Behavioral:
• Psychoanalytic therapy

Locations

Country	Name	City	State
India	Sonal Foundation	Ahmadabad	Gujarat
India	NMP Medical Research Institute	Jhunjhunu	Rajasthan

Sponsors (2)

Lead Sponsor	Collaborator
Macmillan Research Group UK	Sonal Foundation, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Abuse and neglect outcomes		Upto six weeks reported incidences of abuse and maltreatment	No
Primary	Post Natal Depression		Change from baseline in Edinburgh Postnatal Depression Scale at 6 weeks	No
Secondary	Mother-infant interaction		Change from Baseline in Parent/Caregiver Involvement Scale at 6 weeks	No