NCT02116647

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2014

Completed
Last Updated

September 29, 2015

Status Verified

July 1, 2014

Enrollment Period

9 months

First QC Date

April 15, 2014

Last Update Submit

September 27, 2015

Conditions

Abuse NeglectSocial; Deprivation, Maltreatment Syndrome (Infant or Child)

Keywords

Gender discriminationPsychoanalysisRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Post Natal Depression

    Change from baseline in Edinburgh Postnatal Depression Scale at 6 weeks

Secondary Outcomes (1)

  • Mother-infant interaction

    Change from Baseline in Parent/Caregiver Involvement Scale at 6 weeks

Other Outcomes (1)

  • Abuse and neglect outcomes

    Upto six weeks reported incidences of abuse and maltreatment

Study Arms (2)

Psychoanalytic therapy

EXPERIMENTAL

manualized psychoanalytic psychotherapy

Behavioral: Psychoanalytic therapy

Control Group

NO INTERVENTION

Standard care

Interventions

Psychoanalytic therapyBEHAVIORAL
Psychoanalytic therapy

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Families having girl child before
  • High risk families with high expectation of having son

You may not qualify if:

  • Families having son before
  • Relocation and moving out of town during study period
  • Not ready to consent for intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sonal Foundation

Ahmedabad, Gujarat, India

Location

NMP Medical Research Institute

Jhunjhunūn, Rajasthan, India

Location

MeSH Terms

Conditions

Sexism

Interventions

Psychoanalytic Therapy

Condition Hierarchy (Ancestors)

PrejudiceSocial BehaviorBehaviorSocial Discrimination

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Bharat Chaudhari, MA

    Sonal Foundation, India

    STUDY DIRECTOR

  • Mandy Conlon, MA

    Goldington Family Center, UK

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2014

First Posted

April 17, 2014

Study Start

November 1, 2012

Primary Completion

August 1, 2013

Study Completion

November 1, 2013

Last Updated

September 29, 2015

Record last verified: 2014-07

Locations

IN(2)