Abuse Neglect SocialNCT02279368
Nursing Led Interdisciplinary Intervention in Prevention of Girl Child Mortality and Maltreatment
A study testing Family Counselling and safeguarding in people with Abuse Neglect Social and Deprivation, Maltreatment Syndrome (Infant or Child), run by Adwin Life Care at 3 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abuse Neglect Social, Deprivation, Maltreatment Syndrome (Infant or Child)
- What is being tested?
- Family Counselling and safeguarding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 3 sitesIndia
- Study dates
- Sep 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Families having girl child before
- High risk families with high expectation of having son
Who cannot join
- Families having son before
- Relocation and moving out of town during study period
- Not ready to consent for intervention
Trial locations and contacts
3 sites in 1 country.
India3 sites
GyanSanjeevani
Jhunjhunūn, Rajasthan, 302019
Sonal Foundation
Mahesāna, Gujarat
Khatri educational trust
Satnāli, Haryana
About this study
Official title: Nursing Led Interdisciplinary Intervention in Prevention of Girl Child Mortality and Maltreatment: Randomized Controlled Trial
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'.
- Being tested
- Family Counselling and safeguarding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Counselling and safeguardingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Family Counselling and safeguarding |
| Control Group | No intervention | Control group families were followed in usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother-infant interaction (Parent/Caregiver Involvement Scale)
Measured: Change from Baseline in Parent/Caregiver Involvement Scale at 6 weeks
Secondary outcomes (1)
Abuse and neglect outcomes (reported incidences of abuse and maltreatment)
Measured: Upto six weeks reported incidences of abuse and maltreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startSep 2013
- Primary completionMay 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abuse Neglect SocialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adwin Life Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sonal Foundation, India, Gyaansanjeevani, Jhunjhunu, Rajasthan, India, Khatri education trust, Satnaali, Hariyana, India
- Responsible party
- Sponsor
- Investigators
- Alpesh Barot, MA, Principal investigator, Sonal Foundation, IndiaValerie Murray, MA, Study director, Macmillan Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279368
- Sponsor's protocol ID
- Adwin006
- Status last verified
- Oct 2014
- First submitted
- 28 Oct 2014
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Led Interdisciplinary Intervention in Prevention of Girl Child Mortality and Maltreatment: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02279368
- Acronym / sponsor ID
- Adwin006
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Adwin Life CareIndustry (pharma, biotech, devices)
- Collaborators
- Sonal Foundation, India, Gyaansanjeevani, Jhunjhunu, Rajasthan, India, Khatri education trust, Satnaali, Hariyana, India
- Study start
- Sep 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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'.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Family Counselling and safeguardingNurses 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. |
| Control Group | No intervention | –Control group families were followed in usual care. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Families having girl child before
- High risk families with high expectation of having son
Key exclusion criteria (3 listed)
- Families having son before
- Relocation and moving out of town during study period
- Not ready to consent for intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Counselling and safeguarding | Behavioural | Intervention Group |
Primary outcome
Mother-infant interaction (Parent/Caregiver Involvement Scale)
Time frame: Change from Baseline in Parent/Caregiver Involvement Scale at 6 weeks
1 secondary outcome
Abuse and neglect outcomes (reported incidences of abuse and maltreatment)
Time frame: Upto six weeks reported incidences of abuse and maltreatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
Related trials for Abuse Neglect Social
Recruiting
Reducing Parental Substance Use and Enhancing Family Resilience Among Rural Families Through Ohio START
Substance Use Disorder (SUD), Rural Health
Recruiting
Improving Adult Protective Services Client Outcomes: A Stepped-Care Social and Mental Health Engagement Program
Depression in Old Age
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alpesh Barot, MA principal investigator
Sonal Foundation, India
Valerie Murray, MA study director
Macmillan Research Group
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Counselling and safeguarding in people with Abuse Neglect Social and Deprivation, Maltreatment Syndrome (Infant or Child), run by Adwin Life Care at 3 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mother-infant interaction (Parent/Caregiver Involvement Scale) (time frame: Change from Baseline in Parent/Caregiver Involvement Scale at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2014.