Role of Psychoanalysis in Prevention of Girl Child Maltre... | NCT02116647

Studies
Role of Psychoanalysis in Prevention of Girl Child Maltreatment and Neglect

NCT02116647

Sponsor

Macmillan Research Group UK

Status

Completed

Last Update Posted

Sep 29, 2015Estimated

Enrollment

134Actual

Phase

Not Applicable

Conditions

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

Interventions

Psychoanalytic therapy

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Apr 15, 2014

First Submission Date that Met QC Criteria

Apr 15, 2014

First Posted Date

Apr 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2015

Last Update Posted Date

Sep 29, 2015Estimated

Name	Class
Sonal Foundation, India	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

134Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Psychoanalytic therapy	Experimental	manualized psychoanalytic psychotherapy	Behavioral: Psychoanalytic therapy
Control Group	No Intervention	Standard care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Psychoanalytic therapy	Behavioral		Psychoanalytic therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post Natal Depression		Change from baseline in Edinburgh Postnatal Depression Scale at 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Mother-infant interaction		Change from Baseline in Parent/Caregiver Involvement Scale at 6 weeks

Other Outcomes

Measure	Description	Time Frame
Abuse and neglect outcomes		Upto six weeks reported incidences of abuse and maltreatment

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bharat Chaudhari, MA	Sonal Foundation, India	Study Director
Mandy Conlon, MA	Goldington Family Center, UK	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sonal Foundation		Ahmedabad	Gujarat		India
NMP Medical Research Institute

Condition Browse Module

MeSH Terms

ID	Term
D063507	Sexism

Ancestor Terms

ID	Term
D011287	Prejudice
D012919	Social Behavior
D001519	Behavior
D063508	Social Discrimination

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011575	Psychoanalytic Therapy

Ancestor Terms

ID	Term
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided