Pilot Evaluation of the Thriving Mamas Programme

Study Overview
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Brief Summary
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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.

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

Conditions
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Perinatal Mental Health

Intervention / Treatment
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* Other: The Thriving Mamas programme
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thriving Mama programme<br>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<br>* Enhanced antenatal course plus usual perinatal care<br>|
| Active Comparator: Usual perinatal care<br>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<br>* Usual perinatal care<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent mental health, Maternal mental health