NCT02279368

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'.

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 Sep 2013

Geographic Reach
1 country

3 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

September 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
Last Updated

October 31, 2014

Status Verified

October 1, 2014

Enrollment Period

8 months

First QC Date

October 28, 2014

Last Update Submit

October 30, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mother-infant interaction (Parent/Caregiver Involvement Scale)

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

Secondary Outcomes (1)

  • Abuse and neglect outcomes (reported incidences of abuse and maltreatment)

    Upto six weeks reported incidences of abuse and maltreatment

Other Outcomes (1)

  • Child survival rate (reported incidences of injuries and emergencies)

    Upto six weeks reported incidences of injuries and emergencies

Study Arms (2)

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

Intervention Group

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 (3)

Sonal Foundation

Mahesāna, Gujarat, India

Location

Khatri educational trust

Satnāli, Haryana, India

Location

GyanSanjeevani

Jhunjhunūn, Rajasthan, 302019, India

Location

MeSH Terms

Interventions

Family Therapy

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Alpesh Barot, MA

    Sonal Foundation, India

    PRINCIPAL INVESTIGATOR
  • Valerie Murray, MA

    Macmillan Research Group

    STUDY DIRECTOR

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

October 28, 2014

First Posted

October 31, 2014

Study Start

September 1, 2013

Primary Completion

May 1, 2014

Study Completion

October 1, 2014

Last Updated

October 31, 2014

Record last verified: 2014-10

Locations