Pilot Evaluation of the Thriving Mamas Programme for Adolescent Perinatal Mental Health
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Perinatal Mental Health
- Sponsor
- King's College London
- Enrollment
- 141
- Locations
- 2
- Primary Endpoint
- Intervention Feasibility
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Intervention Feasibility
Time Frame: 10-12 weeks post-partum
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
Intervention Acceptability
Time Frame: 10-12 weeks post-partum
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
Intervention Appropriateness
Time Frame: 10-12 weeks post-partum
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
Intervention Fidelity
Time Frame: Through intervention delivery, an average of 24 weeks
Enhancing Assessment of Common Therapeutic Factors (ENACT); subjective report of provider fidelity and perception of care; Minimum=0; Maximum=13; higher score is better
Secondary Outcomes
- Training Appropriateness(Immediately after provider training)
- Knowledge(Baseline and immediately after provider training)
- Training Acceptability(Immediately after provider training)
- Recruitment rate(pre-intervention)
- Cost of intervention(through study completion, an average of 24 weeks)
- Adolescent parenting competency(through study completion, an average of 24 weeks)
- Change in adolescent pregnancy attitudes(Baseline and immediately after provider training)
- Change in mental health attitudes(Baseline and immediately after provider training)
- Provider competency(Immediately after provider training)
- Referral uptake(10-12 weeks post-partum)
- Training Feasibility(Immediately after provider training)
- Change in adolescent depression(through study completion, an average of 24 weeks)
- Change in adolescent anxiety(through study completion, an average of 24 weeks)
- Change in adolescent social support(through study completion, an average of 24 weeks)
- Change in breastfeeding(Baseline and 10-12 weeks post-partum)
- Change in adolescent quality of life(through study completion, an average of 24 weeks)
- Perinatal appointment attendance(through study completion, an average of 24 weeks)
- Change in infant vaccination(Baseline and 10-12 weeks post-partum)
- Change in perception of intervention(Baseline and 10-12 weeks post-partum)
- Change in intended time to next pregnancy(Baseline and 10-12 weeks post-partum)
- Change in contraceptive use(Baseline and 10-12 weeks post-partum)