Nursing Led Interdisciplinary Intervention in Prevention... | NCT02279368

Studies
Nursing Led Interdisciplinary Intervention in Prevention of Girl Child Mortality and Maltreatment

NCT02279368

Sponsor

Adwin Life Care

Status

Completed

Last Update Posted

Oct 31, 2014Estimated

Enrollment

134Actual

Phase

Not Applicable

Conditions

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

Interventions

Family Counselling and safeguarding

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

Oct 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

Sep 2013

Primary Completion Date

May 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Oct 28, 2014

First Submission Date that Met QC Criteria

Oct 30, 2014

First Posted Date

Oct 31, 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

Oct 30, 2014

Last Update Posted Date

Oct 31, 2014Estimated

Name	Class
Sonal Foundation, India	OTHER
Gyaansanjeevani, Jhunjhunu, Rajasthan, India	UNKNOWN
Khatri education trust, Satnaali, Hariyana, India	UNKNOWN

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 Northern India, 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, they now 'neglect' girl child to ensure there are few survivors. Survival chances of second and third daughters are plunging neglecting healthcare and nutrition has become tool for death as 'good riddance'.

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
Intervention Group	Experimental	Nurses delivered the supportive intervention along with family counselling from last term of pregnancy through three months and then were followed till the first birthday of the child.	Behavioral: Family Counselling and safeguarding
Control Group	No Intervention	Control group families were followed in usual care.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Family Counselling and safeguarding	Behavioral		Intervention Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Child survival rate (reported incidences of injuries and emergencies)		Upto six weeks reported incidences of injuries and emergencies

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
Alpesh Barot, MA	Sonal Foundation, India	Principal Investigator
Valerie Murray, MA	Macmillan Research Group	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sonal Foundation		Mahesāna	Gujarat		India
Khatri educational trust

Intervention Browse Module

MeSH Terms

ID	Term
D005196	Family Therapy

Ancestor Terms

ID	Term
D011615	Psychotherapy, Group
D012960	Socioenvironmental Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided