Clinical trial NCT06040359: Pilot Evaluation of the Thriving Mamas Programme
Official title: Pilot Evaluation of the Thriving Mamas Programme for Adolescent Perinatal Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Mental Health
Keywords: Adolescent mental health
Maternal mental health
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Aga Khan University
name: Centro Internacional para Saude Reprodutiva Mocambique
name: UK Research and Innovation
First posted: 2023-09-15
Enrollment: 141
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Intervention Feasibility
timeFrame: 10-12 weeks post-partum
measure: Intervention Acceptability
timeFrame: 10-12 weeks post-partum
measure: Intervention Appropriateness
timeFrame: 10-12 weeks post-partum
measure: Intervention Fidelity
timeFrame: Through intervention delivery, an average of 24 weeks
Secondary outcomes:
measure: Training Feasibility
timeFrame: Immediately after provider training
measure: Training Acceptability
timeFrame: Immediately after provider training
measure: Training Appropriateness
timeFrame: Immediately after provider training
measure: Knowledge
timeFrame: Baseline and immediately after provider training
measure: Change in mental health attitudes
timeFrame: Baseline and immediately after provider training
measure: Change in adolescent pregnancy attitudes
timeFrame: Baseline and immediately after provider training
measure: Provider competency
timeFrame: Immediately after provider training
measure: Recruitment rate
timeFrame: pre-intervention
measure: Cost of intervention
timeFrame: through study completion, an average of 24 weeks
measure: Change in adolescent depression
timeFrame: through study completion, an average of 24 weeks
measure: Change in adolescent anxiety
timeFrame: through study completion, an average of 24 weeks
measure: Change in adolescent quality of life
timeFrame: through study completion, an average of 24 weeks
measure: Change in adolescent social support
timeFrame: through study completion, an average of 24 weeks
measure: Adolescent parenting competency
timeFrame: through study completion, an average of 24 weeks
measure: Perinatal appointment attendance
timeFrame: through study completion, an average of 24 weeks
measure: Referral uptake
timeFrame: 10-12 weeks post-partum
measure: Change in infant vaccination
timeFrame: Baseline and 10-12 weeks post-partum
measure: Change in breastfeeding
timeFrame: Baseline and 10-12 weeks post-partum
measure: Change in intended time to next pregnancy
timeFrame: Baseline and 10-12 weeks post-partum
measure: Change in contraceptive use
timeFrame: Baseline and 10-12 weeks post-partum
measure: Change in perception of intervention
timeFrame: Baseline and 10-12 weeks post-partum
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Aga Khan University
city: Maputo
country: Mozambique
facility: Centro Internacional para Saude Reprodutiva Mocambique
Study officials:
References: