Pilot Evaluation of the Thriving Mamas Programme

King's College London

Status: Completed

Conditions: Perinatal Mental Health

Treatments: Other: Usual care; Other: The Thriving Mamas programme

Study type: Interventional

Funder types: Other

Identifiers

NCT06040359

HR/DP-22/23-39521

Details and patient eligibility

About

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.

Enrollment: 141 patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

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
• Friends/family members will not be excluded so long as they meet inclusion criteria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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141 participants in 2 patient groups

Thriving Mama programme

Experimental group

Description:

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.

Treatment:

Other: The Thriving Mamas programme

Usual perinatal care

Active Comparator group

Description:

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)

Treatment:

Other: Usual care