Abuse NeglectNCT02116647
Role of Psychoanalysis in Prevention of Girl Child Maltreatment and Neglect
A study testing Psychoanalytic therapy in people with Abuse Neglect and Social; Deprivation, Maltreatment Syndrome (Infant or Child), run by Macmillan Research Group UK at 2 sites in India.
Trial 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… 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?
- Psychoanalytic therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 2 sitesIndia
- Study dates
- Nov 2012to Nov 2013
- 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
2 sites in 1 country.
India2 sites
Sonal Foundation
Ahmedabad, Gujarat
NMP Medical Research Institute
Jhunjhunūn, Rajasthan
About this study
Official title: Role of Psychoanalysis in Prevention of Girl Child Maltreatment and Neglect: A Randomized Controlled Trial
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.
- Being tested
- Psychoanalytic therapy
- Keywords
- Gender discrimination, Psychoanalysis, Randomized controlled trial
- Medical subject headings
- Sexism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoanalytic therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Psychoanalytic therapy | Experimental | manualized psychoanalytic psychotherapy Receives: Behavioral: Psychoanalytic therapy |
| Control Group | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Natal Depression
Measured: Change from baseline in Edinburgh Postnatal Depression Scale at 6 weeks
Secondary outcomes (1)
Mother-infant interaction
Measured: Change from Baseline in Parent/Caregiver Involvement Scale at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startNov 2012
- Primary completionAug 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abuse NeglectStudies 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
- Macmillan Research Group UK
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sonal Foundation, India
- Responsible party
- Sponsor
- Investigators
- Bharat Chaudhari, MA, Study director, Sonal Foundation, IndiaMandy Conlon, MA, Study chair, Goldington Family Center, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116647
- Sponsor's protocol ID
- Mac/NMP 1130
- Status last verified
- Jul 2014
- First submitted
- 15 Apr 2014
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Psychoanalysis in Prevention of Girl Child Maltreatment and Neglect: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02116647
- Acronym / sponsor ID
- Mac/NMP 1130
- Keywords
- Gender discrimination, Psychoanalysis, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Macmillan Research Group UKIndustry (pharma, biotech, devices)
- Collaborators
- Sonal Foundation, India
- Study start
- Nov 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 17 Apr 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoanalytic therapy | Experimental | Behavioral: Psychoanalytic therapymanualized psychoanalytic psychotherapy |
| Control Group | No intervention | –Standard 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 |
|---|---|---|
| Psychoanalytic therapy | Behavioural | Psychoanalytic therapy |
Primary outcome
Post Natal Depression
Time frame: Change from baseline in Edinburgh Postnatal Depression Scale at 6 weeks
1 secondary outcome
Mother-infant interaction
Time frame: Change from Baseline in Parent/Caregiver Involvement Scale at 6 weeks
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 29 Sep 2015.
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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.
Bharat Chaudhari, MA study director
Sonal Foundation, India
Mandy Conlon, MA study chair
Goldington Family Center, UK
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoanalytic therapy in people with Abuse Neglect and Social; Deprivation, Maltreatment Syndrome (Infant or Child), run by Macmillan Research Group UK at 2 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 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Post Natal Depression (time frame: Change from baseline in Edinburgh Postnatal Depression 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 29 Sep 2015.