- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT05213182
Peer Support Intervention to Mitigate Social Isolation and Stigma of Adolescent Motherhood in Zimbabwe
Community-Based Peer Support Intervention to Mitigate Social Isolation and Stigma of Adolescent Motherhood in Harare, Zimbabwe
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
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Pennsylvania
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West Chester, Pennsylvania, Vereinigte Staaten, 19383
- West Chester University of Pennsylvania
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Intervention
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.
|
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.
Andere Namen:
|
Kein Eingriff: Control
The control arm (n=79 adolescent mothers) completed sociodemographic, base-, mid- and end-line surveys.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Depressive Symptoms and Suicidal Ideation
Zeitfenster: 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.
|
6 months
|
Perceived Social Support
Zeitfenster: 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.
|
6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Common Mental Disorders
Zeitfenster: 6 months
|
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
|
Peer and Significant Adult Support
Zeitfenster: 6 months
|
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
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Chiwoneso Tinago, PhD, West Chester University of Pennsylvania
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 20180723A
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
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