Pilot Evaluation of the Thriving Mamas Programme

NCT06040359 | Completed

• 1 other identifier: HR/DP-22/23-39521
• Study Type: interventional
• Target: 141
• Locations: 2 countries
• Sites: 2

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

Keywords

Adolescent mental health; Maternal mental health

Outcome Measures

Primary Outcomes (4)

• Intervention Feasibility

  Feasibility of Intervention Measure (FIM); Subjective report of feasibility of intervention; measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Minimum=5, Maximum=25; higher score is better

  10-12 weeks post-partum

• Intervention Acceptability

  Acceptability of Intervention Measure (AIM); Subjective report of acceptability of intervention; A 5-item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Minimum=5, Maximum=25; higher score is better

  10-12 weeks post-partum

• Intervention Appropriateness

  Intervention Appropriateness Measure (IAM); Subjective report of appropriateness of intervention; A 5-item scale that measures the perceived fit, relevance, or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer, and/or perceived fit of the innovation to address a particular issue or problem. Minimum=5, Maximum=25; higher score is better

  10-12 weeks post-partum

• Intervention Fidelity

  Enhancing Assessment of Common Therapeutic Factors (ENACT); subjective report of provider fidelity and perception of care; Minimum=0; Maximum=13; higher score is better

  Through intervention delivery, an average of 24 weeks

Secondary Outcomes (21)

• Training Feasibility

  Immediately after provider training

• Training Acceptability

  Immediately after provider training

• Training Appropriateness

  Immediately after provider training

• Knowledge

  Baseline and immediately after provider training

• Change in mental health attitudes

  Baseline and immediately after provider training

Study Arms (2)

Thriving Mama programme

EXPERIMENTAL

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.

Other: The Thriving Mamas programme

Usual perinatal care

ACTIVE COMPARATOR

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)

Other: Usual care

Interventions

The Thriving Mamas programme OTHER

Enhanced antenatal course plus usual perinatal care

Thriving Mama programme

Usual care OTHER

Usual perinatal care

Usual perinatal care

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Aga Khan University: collaborator
• Centro Internacional para Saude Reprodutiva Mocambique: collaborator
• UK Research and Innovation: collaborator

Study Sites (2)

Aga Khan University

Nairobi, Kenya

Location

Centro Internacional para Saude Reprodutiva Mocambique

Maputo, Mozambique

Location

Related Publications (1)

• 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.

  PMID: 40537871 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 15, 2023
• Study Start: October 1, 2023
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

KE (1); MO (1)