Peer Support Intervention to Mitigate Social Isolation and Stigma of Adolescent Motherhood in Zimbabwe
Primary Purpose
Mental Health Disorder, Social Isolation, Stigma, Social
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Young Women of Today
Sponsored by
About this trial
This is an interventional prevention trial for Mental Health Disorder focused on measuring Adolescent Mothers, Mental Health, Social Isolation, Stigma, Zimbabwe, Peer Support, WhatsApp Messenger
Eligibility Criteria
Inclusion Criteria:
- Adolescent mothers (pregnant and/or have a child or children) aged 14-18 years living in the intervention or control communities.
Exclusion Criteria:
- Individuals who are not adolescent mothers aged 14-18 years and who do not live in the intervention or control communities.
- individuals with an acute or severe illness or disability (e.g. psychosis) that results in a functional impairment that substantially interferes with the ability to provide informed consent and participate in the study.
Sites / Locations
- West Chester University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
The intervention arm (n=104 adolescent mothers) participated in the 12 in-person peer support group sessions and completed sociodemographic, base-, mid-, and end-line surveys.
The control arm (n=79 adolescent mothers) completed sociodemographic, base-, mid- and end-line surveys.
Outcomes
Primary Outcome Measures
Depressive Symptoms and Suicidal Ideation
Change from baseline to endline in depressive symptoms and suicide ideation using the Patient Health Questionnaire, a validated 9-item tool utilized to screen, diagnose, monitor, and measure depression severity and suicide ideation. The scoring of the questionnaire is as follows: 0-4 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression. Thus higher scores mean a worse outcome.
Perceived Social Support
Change from baseline to endline in perceived social support using the Multidimensional Scale of Perceived Social Support a validated scale that measures perceived social support among participants' friends, family and significant others.This scale has 12 items used to assess social support using a Likert scale. The scale measures social support from three categories: family, friends, and significant other. Results ranging from 1 to 2.9 could be considered low support; a score of 3 to 5 could be considered moderate support; a score from 5.1 to 7 could be considered high support. Thus higher scores mean a better outcome.
Secondary Outcome Measures
Common Mental Disorders
Change from baseline to endline in common mental disorders using the 14-item Shona Symptom Questionnaire, a culturally appropriate common mental disorders screening tool. Participants scoring 7 or below are defined as not having a common mental disorder. Participants scoring 8 or more are defined as having a common mental disorder. Thus higher scores mean a worse outcome.
Peer and Significant Adult Support
Change from baseline to endline in peer and significant adult support using the Peer and Significant Adult Support Survey, which was developed by the research team. Using a Likert scale of 0 (not at all), 1 (some of the time), 2 (most of the time), and 3 (all the time) to measure perceived social support from peers and significant adults, a higher score means a better outcome.
Full Information
NCT ID
NCT05213182
First Posted
January 5, 2022
Last Updated
January 31, 2022
Sponsor
West Chester University of Pennsylvania
Collaborators
Bill and Melinda Gates Foundation, University of South Carolina, Organization for Public Health Interventions and Development, University of Zimbabwe, SpeakUp! Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT05213182
Brief Title
Peer Support Intervention to Mitigate Social Isolation and Stigma of Adolescent Motherhood in Zimbabwe
Official Title
Community-Based Peer Support Intervention to Mitigate Social Isolation and Stigma of Adolescent Motherhood in Harare, Zimbabwe
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Chester University of Pennsylvania
Collaborators
Bill and Melinda Gates Foundation, University of South Carolina, Organization for Public Health Interventions and Development, University of Zimbabwe, SpeakUp! Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A community-based peer support intervention for adolescent mothers aged 14-18 years in Harare, Zimbabwe was developed and tested in partnership with adolescent mothers, community health workers, and key community stakeholders. The intervention leveraged peer support, technology via WhatsApp Messenger, community health workers, peer educators and involvement of key community stakeholders to reduce prevalence of loneliness, depressive symptoms and common mental disorders, improve perceived social support, and develop coping, parenting, and communication skills to mitigate potential stressors and stigma of adolescent motherhood.
Detailed Description
Adolescent mothers in Zimbabwe often experience stigma and feel isolated due to lack of social support with a loss of social networks and educational opportunities. Adolescent mothers may also lack coping skills and resources to successfully navigate motherhood. Unless addressed, these circumstances may have negative consequences for the mental health of the adolescent mother and downstream consequences for their children. A quasi-experimental design was used, and the research tested differential changes over base-, mid-, and end-line in mental health and social support outcomes among adolescent mothers (14-18 years) in the intervention and control arms. The study addressed two objectives:
Understand and describe perceptions and experiences with adolescent motherhood and their influence on health.
Explore the acceptability and effectiveness of a community-based peer support intervention for adolescent mothers in a high-density low-income community in Harare to mitigate potential stressors and stigma of adolescent motherhood.
Adolescent mothers engaged as active participants in the development (e.g., defining their needs) and implementation of the intervention which also involved key community stakeholders to address stigma related to mental illness and adolescent motherhood. Existing community resources were leveraged such as peer support, health workers, and technology through WhatsApp Messenger, a popular and low-cost messaging app, to deliver some intervention components and as a platform for communication and training support for peer support group facilitators. Community health workers and peer educators in the intervention arm were recruited and trained on co-facilitating peer support groups. The intervention arm (n=104 adolescent mothers) participated in the peer support groups and completed sociodemographic, base-, mid-, and end-line surveys. The control arm (n=79 adolescent mothers) completed sociodemographic, base-, mid- and end-line surveys. Peer support groups (12 groups with 6-12 participants in each group) met in-person twice a month and completed 12 peer-group sessions from May-August 2019 addressing participant identified topics such as income generation, depression, and healthy parenting. WhatsApp Messenger was used for training and implementation support. Key community stakeholders met to discuss project progress and recommendations to improve the health of adolescent mothers. Data were analyzed using Stata 13 software.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Disorder, Social Isolation, Stigma, Social
Keywords
Adolescent Mothers, Mental Health, Social Isolation, Stigma, Zimbabwe, Peer Support, WhatsApp Messenger
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A quasi-experimental design was used, and the research tested differential changes over base-, mid-, and end-line in mental health and social support outcomes among adolescent mothers (14-18 years) in the intervention and control arms.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
183 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention arm (n=104 adolescent mothers) participated in the 12 in-person peer support group sessions and completed sociodemographic, base-, mid-, and end-line surveys.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control arm (n=79 adolescent mothers) completed sociodemographic, base-, mid- and end-line surveys.
Intervention Type
Behavioral
Intervention Name(s)
Young Women of Today
Other Intervention Name(s)
Community-based Peer Support Intervention to Mitigate Social Isolation and Stigma of Adolescent Motherhood in Harare, Zimbabwe
Intervention Description
Adolescent mothers engaged in the development and implementation of the intervention which also involved key community stakeholders to address stigma related to mental illness and adolescent motherhood. Community health workers and peer educators in the intervention arm were recruited and trained on co-facilitating peer support groups. The intervention arm (n=104 adolescent mothers) participated in the peer support groups and completed sociodemographic, base-, mid-, and end-line surveys. The control arm (n=79 adolescent mothers) completed sociodemographic, base-, mid- and end-line surveys. Peer support groups (12 groups with 6-12 participants in each group) met in-person twice a month and completed 12 peer-group sessions from May-August 2019 addressing participant identified topics such as depression. WhatsApp Messenger was used for training and implementation support. Key community stakeholders met to discuss project progress and recommendations to improve adolescent mothers' health.
Primary Outcome Measure Information:
Title
Depressive Symptoms and Suicidal Ideation
Description
Change from baseline to endline in depressive symptoms and suicide ideation using the Patient Health Questionnaire, a validated 9-item tool utilized to screen, diagnose, monitor, and measure depression severity and suicide ideation. The scoring of the questionnaire is as follows: 0-4 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression. Thus higher scores mean a worse outcome.
Time Frame
6 months
Title
Perceived Social Support
Description
Change from baseline to endline in perceived social support using the Multidimensional Scale of Perceived Social Support a validated scale that measures perceived social support among participants' friends, family and significant others.This scale has 12 items used to assess social support using a Likert scale. The scale measures social support from three categories: family, friends, and significant other. Results ranging from 1 to 2.9 could be considered low support; a score of 3 to 5 could be considered moderate support; a score from 5.1 to 7 could be considered high support. Thus higher scores mean a better outcome.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Common Mental Disorders
Description
Change from baseline to endline in common mental disorders using the 14-item Shona Symptom Questionnaire, a culturally appropriate common mental disorders screening tool. Participants scoring 7 or below are defined as not having a common mental disorder. Participants scoring 8 or more are defined as having a common mental disorder. Thus higher scores mean a worse outcome.
Time Frame
6 months
Title
Peer and Significant Adult Support
Description
Change from baseline to endline in peer and significant adult support using the Peer and Significant Adult Support Survey, which was developed by the research team. Using a Likert scale of 0 (not at all), 1 (some of the time), 2 (most of the time), and 3 (all the time) to measure perceived social support from peers and significant adults, a higher score means a better outcome.
Time Frame
6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants who identified as adolescent mothers (pregnant and/or have a child or children) aged 14-18 years.
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adolescent mothers (pregnant and/or have a child or children) aged 14-18 years living in the intervention or control communities.
Exclusion Criteria:
Individuals who are not adolescent mothers aged 14-18 years and who do not live in the intervention or control communities.
individuals with an acute or severe illness or disability (e.g. psychosis) that results in a functional impairment that substantially interferes with the ability to provide informed consent and participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiwoneso Tinago, PhD
Organizational Affiliation
West Chester University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Chester University of Pennsylvania
City
West Chester
State/Province
Pennsylvania
ZIP/Postal Code
19383
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Peer Support Intervention to Mitigate Social Isolation and Stigma of Adolescent Motherhood in Zimbabwe
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