Stress, PsychologicalNCT02739178
The Sukhshanti Study: Effect of a Sanitation Intervention on Women's Health
A study testing GSF Intervention in people with Stress, Psychological, run by University of Oklahoma at 1 site in India.
Trial summary
The study will measure the impact of sanitation access on women and girl's social and emotional health, behaviors, and quality of life in rural India before and after a sanitation intervention compared to a comparison group that will receive the same intervention at a later date. Read more about this study
- Who is it for?
- Ages 14 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- GSF Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,275 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2016to May 2018
- 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 14 to 65 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- between 14 years to 65 years old
- live in geographic area receiving GSF sanitation intervention in 2016
- live in geographic areas matched to intervention communities
Who cannot join
- less than 25 years old and not reached menarche
- greater than 25 years old and never married
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Sukhshanti Study: a Controlled Before-and-after Mixed Methods Study of the Effect of a Sanitation Intervention on Women's Health in Bihar, India
The study will measure the impact of sanitation access on women and girl's social and emotional health, behaviors, and quality of life in rural India before and after a sanitation intervention compared to a comparison group that will receive the same intervention at a later date.
Read the detailed description
This mixed-methods, quasi-experimental study will evaluate the extent to which the Global Sanitation Fund (GSF) sanitation program in Bihar, India improves health and well-being among women and girls. Our study consists of a controlled before-and-after (CBA) study with an embedded ethnography.
Specific objectives are:
- Measure the effect of the GSF intervention on sanitation-related psychosocial stress (SRPS), generalized psychosocial stress (PSS), perceived quality of life, hair cortisol, and urogenital health among women between the ages of 14 and 65.
- Measure changes in sanitation adoption (e.g.: sanitation access and exclusive use) among individuals / households receiving the GSF intervention.
- Document individual and community experiences with sanitation, intervention participation, and latrine coverage through ethnographic methods.
- Conditions
- Stress, Psychological
- Being tested
- GSF Intervention
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSF InterventionOther
Intervention utilizes community-based demand generation matched with supply side improvements to improve access and use of sanitation facilities in rural communities. This is complimented with multi-stakeholder engagement to promote cooperation and coordination with national, state, and local stakeholders.
| Study group | Role | What they receive |
|---|---|---|
| GSF Sanitation intervention | Experimental | This arm will receive the GSF sanitation intervention, a community-level sanitation intervention Receives: Other: GSF Intervention |
| Comparator | No intervention | This arm will receive the GSF intervention in 2017 or later. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sanitation-Related Psychosocial Stress Scale (SRPS)
The SRPS consist of 25 yes/no questions on experiences related to sanitation within the past thirty days of the date the SRPS is completed.This SRPS Scale specifically includes questions related to defecation, menstrual hygiene management, and post-defecation cleaning - the three behaviors that have the greatest contribution to sanitation-related psychosocial stress among women in India.
Measured: 12 month follow-up
Secondary outcomes (6)
Perceived Stress Scale (PSS10)
A measure for non-specific perceived stress. The PSS10 is the short form of the PSS and consist of 10 items rated on a 5-point Likert scale (0 to 4). Scores are calculated by reverse scoring items with positive wording and summing across all items for a final score of 0 to 40. The PSS10 is not a diagnostic scale.
Measured: 12 month follow-up
Kessler Psychological Distress Scale (K10)
The K10 provides a measure of non-specific psychological distress and consists of 10 items rated on a 5-point Likert scale (1 to 5). Scores are calculated by summing response across each item.
Measured: 12 month follow-up
The WHO5 Well-Being Index (WHO-5)
The WHO5 consist of 5 items rated on a 6-point Likert scale (0 to 5) related to subjective well-being, vitality, and mood.
Measured: 12 month follow-up
Self-reported urogenital infections
Urogenital infections, a health outcome linked to both menstrual hygiene management practices and sanitation access (Das et al., 2015) will be identified through self-report of any one of the following four symptoms: abnormal vaginal discharge (unusual texture / color and/or more abundant discharge than normal), burning or itching of the genitalia, burning or itching when urinating, or having genital sores.
Measured: 12 month follow-up
Hair cortisol
Hair cortisol will be assessed in a sub-sample of women in both intervention and comparison communities.
Measured: 12 month follow-up
Sleep duration
Sleep duration will be assessed through a variety of self-report methods. The investigators will adapt questions from the Pittsburgh Sleep Quality Index that assess sleep duration over the past month: 1. During this past month, how many hours of actual sleep did the participant usually get at night? (Herring et al., 2013). The investigators will also ask the following questions: 1. To the best of the participant's knowledge, what time did the participant go to bed last night? 2. To the best of the participant's knowledge, what time did the participant wake up this morning?
Measured: 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2018
- Study completionMay 2018
Why it stopped: Administratively inactivated by IRB due to no response for Continuing Review
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,275 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver Cumming, Mr., Study director, London School of Hygiene and Tropical MedicineKathleen O'Reilly, PhD, Study director, Texas A&M UniversitySeema Kulkarni, Study director, Society for the Promotion of Participatory Ecosystem Management (SOPPECOM)Robert Dreibelbis, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739178
- Sponsor's protocol ID
- 6580 Norman
- Status last verified
- Apr 2019
- First submitted
- 5 Apr 2016
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified data will be made available after completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sukhshanti Study: a Controlled Before-and-after Mixed Methods Study of the Effect of a Sanitation Intervention on Women's Health in Bihar, India
- ClinicalTrials.gov ID
- NCT02739178
- Acronym / sponsor ID
- 6580 Norman
- Conditions
- Stress, Psychological
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administratively inactivated by IRB due to no response for Continuing Review
- Enrolment
- 1,275 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 15 Apr 2016 (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.
The study will measure the impact of sanitation access on women and girl's social and emotional health, behaviors, and quality of life in rural India before and after a sanitation intervention compared to a comparison group that will receive the same intervention at a later date.
Detailed description
This mixed-methods, quasi-experimental study will evaluate the extent to which the Global Sanitation Fund (GSF) sanitation program in Bihar, India improves health and well-being among women and girls. Our study consists of a controlled before-and-after (CBA) study with an embedded ethnography.
Specific objectives are:
- Measure the effect of the GSF intervention on sanitation-related psychosocial stress (SRPS), generalized psychosocial stress (PSS), perceived quality of life, hair cortisol, and urogenital health among women between the ages of 14 and 65.
- Measure changes in sanitation adoption (e.g.: sanitation access and exclusive use) among individuals / households receiving the GSF intervention.
- Document individual and community experiences with sanitation, intervention participation, and latrine coverage through ethnographic methods.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSF Sanitation intervention | Experimental | Other: GSF InterventionThis arm will receive the GSF sanitation intervention, a community-level sanitation intervention |
| Comparator | No intervention | –This arm will receive the GSF intervention in 2017 or later. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- between 14 years to 65 years old
- live in geographic area receiving GSF sanitation intervention in 2016
- live in geographic areas matched to intervention communities
Key exclusion criteria (3 listed)
- less than 25 years old and not reached menarche
- greater than 25 years old and never married
- refusal to participate
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 |
|---|---|---|
| GSF InterventionIntervention utilizes community-based demand generation matched with supply side improvements to improve access and use of sanitation facilities in rural communities. This is complimented with multi-stakeholder engagement to promote cooperation and coordination with national, state, and local stakeholders. | Other | GSF Sanitation intervention |
Primary outcome
Sanitation-Related Psychosocial Stress Scale (SRPS)
Time frame: 12 month follow-up
The SRPS consist of 25 yes/no questions on experiences related to sanitation within the past thirty days of the date the SRPS is completed.This SRPS Scale specifically includes questions related to defecation, menstrual hygiene management, and post-defecation cleaning - the three behaviors that have the greatest contribution to sanitation-related psychosocial stress among women in India.
6 secondary outcomes
Perceived Stress Scale (PSS10)
Time frame: 12 month follow-up
Kessler Psychological Distress Scale (K10)
Time frame: 12 month follow-up
The WHO5 Well-Being Index (WHO-5)
Time frame: 12 month follow-up
Self-reported urogenital infections
Time frame: 12 month follow-up
Hair cortisol
Time frame: 12 month follow-up
Sleep duration
Time frame: 12 month follow-up
Results and safety
The study was stopped early (reason given: Administratively inactivated by IRB due to no response for Continuing Review). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: Yes. De-identified data will be made available after completion of the study.
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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.
Oliver Cumming, Mr. study director
London School of Hygiene and Tropical Medicine
Kathleen O'Reilly, PhD study director
Texas A&M University
Seema Kulkarni study director
Society for the Promotion of Participatory Ecosystem Management (SOPPECOM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GSF Intervention in people with Stress, Psychological, run by University of Oklahoma at 1 site 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 3 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: stopped early, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Administratively inactivated by IRB due to no response for Continuing Review). Results are not available in the source record.
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?
Sanitation-Related Psychosocial Stress Scale (SRPS) (time frame: 12 month follow-up). 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 4 Apr 2019.