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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05213182
Other study ID # 20180723A
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 1, 2018
Est. completion date September 30, 2019

Study information

Verified date January 2022
Source West Chester University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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: 1. Understand and describe perceptions and experiences with adolescent motherhood and their influence on health. 2. 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.


Recruitment information / eligibility

Status Completed
Enrollment 183
Est. completion date September 30, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years to 18 Years
Eligibility 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.

Study Design


Intervention

Behavioral:
Young Women of Today
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.

Locations

Country Name City State
United States West Chester University of Pennsylvania West Chester Pennsylvania

Sponsors (6)

Lead Sponsor Collaborator
West Chester University of Pennsylvania Bill and Melinda Gates Foundation, Organization for Public Health Interventions and Development, SpeakUp! Pennsylvania, University of South Carolina, University of Zimbabwe

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months
Primary 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. 6 months
Secondary 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. 6 months
Secondary 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. 6 months
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