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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02279368
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : October 31, 2014
Sponsor:
Collaborators:
Sonal Foundation, India
Gyaansanjeevani, Jhunjhunu, Rajasthan, India
Khatri education trust, Satnaali, Hariyana, India
Information provided by (Responsible Party):
Adwin Life Care

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'.

Condition or disease Intervention/treatment Phase
Abuse Neglect Social Deprivation, Maltreatment Syndrome (Infant or Child) Behavioral: Family Counselling and safeguarding Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Nursing Led Interdisciplinary Intervention in Prevention of Girl Child Mortality and Maltreatment: Randomized Controlled Trial
Study Start Date : September 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: Intervention Group
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
No Intervention: Control Group
Control group families were followed in usual care.



Primary Outcome Measures :
  1. Mother-infant interaction (Parent/Caregiver Involvement Scale) [ Time Frame: Change from Baseline in Parent/Caregiver Involvement Scale at 6 weeks ]

Secondary Outcome Measures :
  1. Abuse and neglect outcomes (reported incidences of abuse and maltreatment) [ Time Frame: Upto six weeks reported incidences of abuse and maltreatment ]

Other Outcome Measures:
  1. Child survival rate (reported incidences of injuries and emergencies) [ Time Frame: Upto six weeks reported incidences of injuries and emergencies ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279368


Locations
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India
Sonal Foundation
Mahesana, Gujarat, India
Khatri educational trust
Satnali, Hariyana, India
GyanSanjeevani
Jhunjhunu, Rajasthan, India, 302019
Sponsors and Collaborators
Adwin Life Care
Sonal Foundation, India
Gyaansanjeevani, Jhunjhunu, Rajasthan, India
Khatri education trust, Satnaali, Hariyana, India
Investigators
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Principal Investigator: Alpesh Barot, MA Sonal Foundation, India
Study Director: Valerie Murray, MA Macmillan Research Group

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Responsible Party: Adwin Life Care
ClinicalTrials.gov Identifier: NCT02279368    
Other Study ID Numbers: Adwin006
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: October 31, 2014
Last Verified: October 2014