Mental Health DisorderPhase 2NCT05213182
Peer Support Intervention to Mitigate Social Isolation and Stigma of Adolescent Motherhood in Zimbabwe
A Phase 2 study testing Young Women of Today in people with Mental Health Disorder and Social Isolation, run by West Chester University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health Disorder, Social Isolation, Stigma, Social
- What is being tested?
- Young Women of Today
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 30 Sep 2019
- Phase
- Phase 2
- 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 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescent mothers (pregnant and/or have a child or children) aged 14-18 years living in the intervention or control communities.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Chester University of Pennsylvania
West Chester, Pennsylvania, 19383
About this study
Official title: Community-Based Peer Support Intervention to Mitigate Social Isolation and Stigma of Adolescent Motherhood in Harare, Zimbabwe
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.
Read the 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.
- Conditions
- Mental Health Disorder, Social Isolation, Stigma, Social
- Being tested
- Young Women of Today
- Keywords
- Adolescent Mothers, Mental Health, Social Isolation, Stigma, Zimbabwe, Peer Support, WhatsApp Messenger
- Medical subject headings
- Mental Disorders, Social Isolation, Social Stigma, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Young Women of TodayBehavioural
Also called Community-based Peer Support Intervention to Mitigate Social Isolation and Stigma of Adolescent Motherhood in Harare, Zimbabwe
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Young Women of Today |
| Control | No intervention | The control arm (n=79 adolescent mothers) completed sociodemographic, base-, mid- and end-line surveys. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Oct 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health DisorderStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Chester University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University of South Carolina, Organization for Public Health Interventions and Development, University of Zimbabwe, SpeakUp! Pennsylvania
- Responsible party
- Principal investigator, Chiwoneso Tinago, West Chester University of Pennsylvania
- Investigators
- Chiwoneso Tinago, PhD, Principal investigator, West Chester University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213182
- Sponsor's protocol ID
- 20180723A
- Status last verified
- Jan 2022
- First submitted
- 5 Jan 2022
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tinago CB, Frongillo EA, Warren AM, Chitiyo V, Jackson TN, Cifarelli AK, Fyalkowski S, Pauline V. Testing the Effectiveness of a Community-Based Peer Support Intervention to Mitigate Social Isolation and Stigma of Adolescent Motherhood in Zimbabwe. Matern Child Health J. 2024 Apr;28(4):657-666. doi: 10.1007/s10995-023-03821-2. Epub 2023 Nov 13.
PubMed 37957412
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Peer Support Intervention to Mitigate Social Isolation and Stigma of Adolescent Motherhood in Harare, Zimbabwe
- ClinicalTrials.gov ID
- NCT05213182
- Acronym / sponsor ID
- 20180723A
- Conditions
- Mental Health Disorder, Social Isolation, Stigma, Social
- Keywords
- Adolescent Mothers, Mental Health, Social Isolation, Stigma, Zimbabwe, Peer Support, WhatsApp Messenger
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- West Chester University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University of South Carolina, Organization for Public Health Interventions and Development, University of Zimbabwe, SpeakUp! Pennsylvania
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 28 Jan 2022 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Young Women of TodayThe 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. |
| Control | No intervention | –The control arm (n=79 adolescent mothers) completed sociodemographic, base-, mid- and end-line surveys. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescent mothers (pregnant and/or have a child or children) aged 14-18 years living in the intervention or control communities.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Young Women of TodayAlso: Community-based Peer Support Intervention to Mitigate Social Isolation and Stigma of Adolescent Motherhood in Harare, ZimbabweAdolescent 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. | Behavioural | Intervention |
Primary outcome
Depressive Symptoms and Suicidal Ideation
Time frame: 6 months
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
Time frame: 6 months
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.
2 secondary outcomes
Common Mental Disorders
Time frame: 6 months
Peer and Significant Adult Support
Time frame: 6 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 15 Feb 2022.
- Derived from this study: PubMed 37957412Tinago CB, Frongillo EA, Warren AM, Chitiyo V, Jackson TN, Cifarelli AK, Fyalkowski S, Pauline V. Testing the Effectiveness of a Community-Based Peer Support Intervention to Mitigate Social Isolation and Stigma of Adolescent Motherhood in Zimbabwe. Matern Child Health J. 2024 Apr;28(4):657-666. doi: 10.1007/s10995-023-03821-2. Epub 2023 Nov 13.
- Individual participant dataSharing planned: No
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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.
Chiwoneso Tinago, PhD principal investigator
West Chester University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Young Women of Today in people with Mental Health Disorder and Social Isolation, run by West Chester University of Pennsylvania 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 1 inclusion and 2 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 15 Feb 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Depressive Symptoms and Suicidal Ideation (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05213182, which also lists 1 linked publication.
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 15 Feb 2022.