Mental Health IssueNCT06065293
Mental Health, Gender-Based Violence, and Stunting in Tanzania
An observational study of Mental Health Issue and Substance Use, run by Colorado State University at 1 site in United States.
Trial summary
One in three children under the age of five in Tanzania experience stunting, which is defined as impairments in growth and development that often occur after poor nutrition, poor health, and low psychosocial stimulation. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Substance Use, Child Development
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 7 Sep 2023
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 162 mothers participating in a local non-profit organization in Tanzania
Who may be able to join
- Living within the 5 rural villages
- participating in a local nonprofit
- pregnant or having a child under 2 years old
Who cannot join
- Living outside of the 5 villages
- Not participating in the local nonprofit
- Not pregnant or having a child under 2 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University
Fort Collins, Colorado, 80537
About this study
Official title: Establishing a Community-led, Family-centered Mental Wellness Initiative in Rural Tanzania
One in three children under the age of five in Tanzania experience stunting, which is defined as impairments in growth and development that often occur after poor nutrition, poor health, and low psychosocial stimulation. Research suggests that mental health problems of parents may be related to stunting outcomes and parental mental health is closely related to experiences of intimate partner violence, also called gender-based violence. However, very little research exists on the connection between these elements, and interventions may be necessary in order to reduce the impacts that mental health and gender-based violence may have on stunting.
This study is a secondary data analysis of de-identified survey and stunting data that were conducted as a part of a needs assessment by a local nonprofit organization in Tanzania. The needs assessment was conducted to inform a mental health initiative organized by the established nonprofit across 5 villages in rural Tanzania. This project's primary aims are:
- To determine the prevalence of mental health and family relationship problems in five villages
- To determine associations between intimate partner violence (IPV) mental health and substance use and childhood stunting
- Conditions
- Mental Health Issue, Substance Use, Child Development
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mothers involved in a local non-profit | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression and anxiety
Hopkins Symptom Checklist
Measured: Through study completion, approximately 2 months
Substance use
Alcohol Use Disorders Identification Test (AUDIT)
Measured: Through study completion, approximately 2 months
World Health Organization (WHO) Violence Against Women
WHO Violence Against Women
Measured: Through study completion, approximately 2 months
Childhood stunting
Height, weight, and head circumference of child under 2.5 years old
Measured: Through study completion, approximately 2 months
Secondary outcomes (1)
Women's Empowerment
Women's Empowerment measure
Measured: Through study completion, approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Jan 2023
- Primary completion7 Sep 2023
- Study completion7 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shelley Haddock, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065293
- Sponsor's protocol ID
- 3916
- Status last verified
- Oct 2023
- First submitted
- 27 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data are de-identified and there is no plan to make it available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Community-led, Family-centered Mental Wellness Initiative in Rural Tanzania
- ClinicalTrials.gov ID
- NCT06065293
- Acronym / sponsor ID
- 3916
- Conditions
- Mental Health Issue, Substance Use, Child Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 3 Oct 2023 (actual)
- 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.
One in three children under the age of five in Tanzania experience stunting, which is defined as impairments in growth and development that often occur after poor nutrition, poor health, and low psychosocial stimulation. Research suggests that mental health problems of parents may be related to stunting outcomes and parental mental health is closely related to experiences of intimate partner violence, also called gender-based violence. However, very little research exists on the connection between these elements, and interventions may be necessary in order to reduce the impacts that mental health and gender-based violence may have on stunting.
This study is a secondary data analysis of de-identified survey and stunting data that were conducted as a part of a needs assessment by a local nonprofit organization in Tanzania. The needs assessment was conducted to inform a mental health initiative organized by the established nonprofit across 5 villages in rural Tanzania. This project's primary aims are:
- To determine the prevalence of mental health and family relationship problems in five villages
- To determine associations between intimate partner violence (IPV) mental health and substance use and childhood stunting
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mothers involved in a local non-profit | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 162 mothers participating in a local non-profit organization in Tanzania
Key inclusion criteria (3 listed)
- Living within the 5 rural villages
- participating in a local nonprofit
- pregnant or having a child under 2 years old
Key exclusion criteria (3 listed)
- Living outside of the 5 villages
- Not participating in the local nonprofit
- Not pregnant or having a child under 2 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Depression and anxiety
Time frame: Through study completion, approximately 2 months
Hopkins Symptom Checklist
Substance use
Time frame: Through study completion, approximately 2 months
Alcohol Use Disorders Identification Test (AUDIT)
World Health Organization (WHO) Violence Against Women
Time frame: Through study completion, approximately 2 months
WHO Violence Against Women
Childhood stunting
Time frame: Through study completion, approximately 2 months
Height, weight, and head circumference of child under 2.5 years old
1 secondary outcome
Women's Empowerment
Time frame: Through study completion, approximately 2 months
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 10 Oct 2023.
- Individual participant dataSharing planned: No. The data are de-identified and there is no plan to make it available to other researchers
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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.
Shelley Haddock, PhD principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Issue and Substance Use, run by Colorado State University at 1 site in United States.
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: finished, as of the sponsor's last update on 10 Oct 2023. 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 United States. 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?
Depression and anxiety (time frame: Through study completion, approximately 2 months). The study lists 4 primary outcomes in all. 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 10 Oct 2023.