Pilot Evaluation of the Thriving Mamas Programme

NCT ID: NCT06040359

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-09-15

Brief Summary

The goal of this pilot study is to evaluate the feasibility, appropriateness, and acceptability of a mental health prevention intervention among adolescents during pregnancy and the year after birth (perinatal period) in Kenya and Mozambique. The main questions it aims to answer are:

• Is the intervention feasible, acceptable, appropriate, and delivered/received with high fidelity, to adolescent girls, their friends/family members and service providers?
• Are the implementation strategies acceptable, appropriate, feasible to all relevant stakeholders?
• What impact does the intervention have on adolescent mothers' mental health?
• What impact does the intervention have on adolescent mothers' social, economic, and education outcomes?

Participants will:

• Participate in nine individual and group sessions focused on improving mental and perinatal health literacy and increasing life skills
• Receive standard perinatal care

Researchers will compare findings with girls receiving standard perinatal care only to see if the intervention has an impact on adolescents' mental health, social, economic and education outcomes.

Conditions

Perinatal Mental Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Thriving Mama programme

Nine meetings delivered in either group (5 meetings), individual (1 meeting), or family group (2 meetings) formats over 10 weeks with an additional individual meeting 10-12 weeks postpartum by a trained mother in the community. Each meeting focuses on the girl's physical and mental health, taking care of a newborn, life skills, future-planning and social support and community-based services. Meetings will take place in a mixture of private settings in health facilities, community facilities, and participant homes. Adolescents will also receive usual perinatal care.

Group Type: EXPERIMENTAL

The Thriving Mamas programme

Intervention Type: OTHER

Enhanced antenatal course plus usual perinatal care

Usual perinatal care

Each visit includes care that is appropriate to the overall condition and stage of pregnancy and should include four main categories of care:

1. Identification of pre-existing health conditions (e.g., check for weight and nutrition status, anemia, hypertension, syphilis, HIV status);

2. Early detection of complications arising during pregnancy (e.g., check for pre-eclampsia, gestational diabetes);

3. Health promotion and disease prevention (e.g., tetanus vaccine, prevention and treatment of malaria, nutrition counseling, micronutrient supplements, family planning counseling); and

4. Birth preparedness and complication planning (e.g., birth and emergency plan, breastfeeding counseling, antiretrovirals for HIV positive women and reducing mother-to- child transmission of HIV)

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

Usual perinatal care

Interventions

The Thriving Mamas programme

Enhanced antenatal course plus usual perinatal care

Intervention Type: OTHER

Usual care

Usual perinatal care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Mentor mothers: (A) aged 20 years or older; (B) female; (C) experience of pregnancy and/or parenting; and (D) live within the study site
• Adolescent girls: (A) up to 28 weeks pregnant; and (B) aged 15-19 years
• Friends/family members: (A) identified by an adolescent or young woman participating in the study; (B) participation agreed by other participating girls; and (C) aged 18 years or older

Exclusion Criteria

• Mentor mothers will be excluded from participating if they are unable to attend training or deliver the intervention sessions
• Adolescent girls will be excluded from the study if they are unable to provide informed consent or are unable to participate in the intervention, due to existing health conditions

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aga Khan University

OTHER

Sponsor Role: collaborator

Centro Internacional para Saude Reprodutiva Mocambique

UNKNOWN

Sponsor Role: collaborator

UK Research and Innovation

OTHER

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aga Khan University

Nairobi, , Kenya

Centro Internacional para Saude Reprodutiva Mocambique

Maputo, , Mozambique

Countries

Kenya; Mozambique

References

Taylor Salisbury T, Maguele MSB, Chissale F, de Melo M, Hanselmann M, Lamahewa K, Lang'at E, Mandlate F, Nyaga L, Seward N, Temmerman M. Supporting the mental health of adolescent mothers in Kenya and Mozambique: pilot protocol for the Thriving Mamas programme. Pilot Feasibility Stud. 2025 Jun 19;11(1):83. doi: 10.1186/s40814-025-01617-5.

Reference Type: DERIVED

PMID: 40537871 (View on PubMed)

Other Identifiers

HR/DP-22/23-39521

Identifier Type: -

Identifier Source: org_study_id