Child Development Clinical Trial
Official title:
Establishing a Community-led, Family-centered Mental Wellness Initiative in Rural Tanzania
NCT number | NCT06065293 |
Other study ID # | 3916 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2023 |
Est. completion date | September 7, 2023 |
Verified date | October 2023 |
Source | Colorado State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 162 |
Est. completion date | September 7, 2023 |
Est. primary completion date | September 7, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Living within the 5 rural villages - participating in a local nonprofit - pregnant or having a child under 2 years old Exclusion Criteria: - Living outside of the 5 villages - Not participating in the local nonprofit - Not pregnant or having a child under 2 years old |
Country | Name | City | State |
---|---|---|---|
United States | Colorado State University | Fort Collins | Colorado |
Lead Sponsor | Collaborator |
---|---|
Colorado State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Depression and anxiety | Hopkins Symptom Checklist | Through study completion, approximately 2 months | |
Primary | Substance use | Alcohol Use Disorders Identification Test (AUDIT) | Through study completion, approximately 2 months | |
Primary | World Health Organization (WHO) Violence Against Women | WHO Violence Against Women | Through study completion, approximately 2 months | |
Primary | Childhood stunting | Height, weight, and head circumference of child under 2.5 years old | Through study completion, approximately 2 months | |
Secondary | Women's Empowerment | Women's Empowerment measure | Through study completion, approximately 2 months |
Status | Clinical Trial | Phase | |
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