Pilot Evaluation of the Thriving Mamas Programme

Pilot Evaluation of the Thriving Mamas Programme for Adolescent Perinatal Mental Health

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.

Study Overview

• Status: Completed
• Conditions: Perinatal Mental Health
• Intervention / Treatment: Other: The Thriving Mamas programme; Other: Usual care

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Nairobi, Kenya
    • Aga Khan University
• Mozambique
  • Maputo, Mozambique
    • Centro Internacional para Saude Reprodutiva Mocambique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: The Thriving Mamas programme; Enhanced antenatal course plus usual perinatal care
Active Comparator: 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: Identification of pre-existing health conditions (e.g., check for weight and nutrition status, anemia, hypertension, syphilis, HIV status);; Early detection of complications arising during pregnancy (e.g., check for pre-eclampsia, gestational diabetes);; Health promotion and disease prevention (e.g., tetanus vaccine, prevention and treatment of malaria, nutrition counseling, micronutrient supplements, family planning counseling); and; 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; Usual perinatal care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Training 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	Immediately after provider training
Training 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	Immediately after provider training
Training 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	Immediately after provider training
Knowledge	Study-specific measure of mentor mothers' knowledge of issues regarding pregnancy, childbirth, caregiving, mental health, and referral pathways will be assessed using a study-specific quiz based upon the intervention manual; Minimum=0, Maximum=16; higher score is better	Baseline and immediately after provider training
Change in mental health attitudes	Social Distance Scale (SDS); The SDS measures the acceptability of different degrees of social distance and, by inference, the attitude of the respondent to the person with the condition; Minimum=1, Maximum=96; higher score is better	Baseline and immediately after provider training
Change in adolescent pregnancy attitudes	Study-specific attitudes towards adolescent pregnancy survey; Minimum=4, Maximum=20; lower score is better	Baseline and immediately after provider training
Provider competency	Study-specific single 10-point scale to assess provider ability to deliver the intervention; Minimum=0, Maximum=10; higher score is better	Immediately after provider training
Recruitment rate	Proportion of adolescents providing consent to participate in the study	pre-intervention
Cost of intervention	Total and average cost of the intervention per participant	through study completion, an average of 24 weeks
Change in adolescent depression	Patient Health Questionnaire (PHQ-9); Nine-item screening tool which assesses depression symptoms according to clinical criteria. Minimum=0, Maximum=27. A score ≥10 indicates moderate to severe depression.	through study completion, an average of 24 weeks
Change in adolescent anxiety	Generalised Anxiety Disorder scale (GAD-7); Seven-item screening tool which assesses anxiety symptoms according to clinical criteria. Minimum=0, Maximum=21. A score ≥10 indicates moderate to severe anxiety.	through study completion, an average of 24 weeks
Change in adolescent quality of life	WHO Quality of Life brief version (WHOQOL-BREF); 26-item scale assesses a respondent's perceived quality of life across four domains: physical health; psychological; social relationships; and environment. Total minimum=25, Total maximum=125. Higher scores indicate greater quality of life in a particular domain.	through study completion, an average of 24 weeks
Change in adolescent social support	Multidimensional Scale of Perceived Social Support (MSPSS); The MSPSS is a 12-item scale which measures social support from family, friends and significant others. Minimum=12, Maximum=84. Higher scores indicate greater social support.	through study completion, an average of 24 weeks
Adolescent parenting competency	Parenting Sense of Competency Scale; 17-item scale to measure adolescents' perceived parenting abilities. Minimum=17, Maximum=102. Higher scores indicate greater perceived competence.	through study completion, an average of 24 weeks
Perinatal appointment attendance	Number of participants attending antenatal appointments	through study completion, an average of 24 weeks
Referral uptake	Proportion of adolescents attending referral appointments	10-12 weeks post-partum
Change in infant vaccination	Number of participants intending to or having had their babies vaccinated	Baseline and 10-12 weeks post-partum
Change in breastfeeding	Number of participants intendng to or are currently breastfeeding	Baseline and 10-12 weeks post-partum
Change in intended time to next pregnancy	Study-specific health behaviours questionnaire to assess intended or actual contraceptive Nuimber of participants that want more children who intend to wait at least 15 months before next pregnancy	Baseline and 10-12 weeks post-partum
Change in contraceptive use	Number of participants intending to or currently using contraceptives to delay pregnancy	Baseline and 10-12 weeks post-partum
Change in perception of intervention	Study-specific five-item measure assessing knowledge gained, interest in intervention, and support recieved; Minimum=0; Maximum=5; higher score is better	Baseline and 10-12 weeks post-partum

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): September 15, 2024
• Study Completion (Actual): September 15, 2024

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Maternal mental health; Adolescent mental health
• Other Study ID Numbers: HR/DP-22/23-39521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No