Pilot Evaluation of the Thriving Mamas Programme
Study Details
Study Description
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:
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Is the intervention feasible, acceptable, appropriate, and delivered/received with high fidelity, to adolescent girls, their friends/family members and service providers?
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Are the implementation strategies acceptable, appropriate, feasible to all relevant stakeholders?
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What impact does the intervention have on adolescent mothers' mental health?
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What impact does the intervention have on adolescent mothers' social, economic, and education outcomes?
Participants will:
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Participate in nine individual and group sessions focused on improving mental and perinatal health literacy and increasing life skills
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Intervention Feasibility [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 [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 [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 [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 Outcome Measures
- Training Feasibility [Immediately after provider training]
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
- Training Acceptability [Immediately after provider training]
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
- Training Appropriateness [Immediately after provider training]
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
- Knowledge [Baseline and immediately after provider training]
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
- Change in mental health attitudes [Baseline and immediately after provider training]
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
- Change in adolescent pregnancy attitudes [Baseline and immediately after provider training]
Study-specific attitudes towards adolescent pregnancy survey; Minimum=4, Maximum=20; lower score is better
- Provider competency [Immediately after provider training]
Study-specific single 10-point scale to assess provider ability to deliver the intervention; Minimum=0, Maximum=10; higher score is better
- Recruitment rate [pre-intervention]
Proportion of adolescents providing consent to participate in the study
- Cost of intervention [through study completion, an average of 24 weeks]
Total and average cost of the intervention per participant
- Change in adolescent depression [through study completion, an average of 24 weeks]
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.
- Change in adolescent anxiety [through study completion, an average of 24 weeks]
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.
- Change in adolescent quality of life [through study completion, an average of 24 weeks]
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.
- Change in adolescent social support [through study completion, an average of 24 weeks]
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.
- Adolescent parenting competency [through study completion, an average of 24 weeks]
Parenting Sense of Competency Scale; 17-item scale to measure adolescents' perceived parenting abilities. Minimum=17, Maximum=102. Higher scores indicate greater perceived competence.
- Perinatal appointment attendance [through study completion, an average of 24 weeks]
Number of participants attending antenatal appointments
- Referral uptake [10-12 weeks post-partum]
Proportion of adolescents attending referral appointments
- Change in infant vaccination [Baseline and 10-12 weeks post-partum]
Number of participants intending to or having had their babies vaccinated
- Change in breastfeeding [Baseline and 10-12 weeks post-partum]
Number of participants intendng to or are currently breastfeeding
- Change in intended time to next pregnancy [Baseline and 10-12 weeks post-partum]
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
- Change in contraceptive use [Baseline and 10-12 weeks post-partum]
Number of participants intending to or currently using contraceptives to delay pregnancy
- Change in perception of intervention [Baseline and 10-12 weeks post-partum]
Study-specific five-item measure assessing knowledge gained, interest in intervention, and support recieved; Minimum=0; Maximum=5; higher score is better
Eligibility Criteria
Criteria
Inclusion Criteria:
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Mentor mothers: (A) aged 20 years or older; (B) female; (C) experience of pregnancy and/or parenting; and (D) live within the study site
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Adolescent girls: (A) up to 28 weeks pregnant; and (B) aged 15-19 years
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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:
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Mentor mothers will be excluded from participating if they are unable to attend training or deliver the intervention sessions
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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
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Friends/family members will not be excluded so long as they meet inclusion criteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aga Khan University | Nairobi | Kenya | ||
| 2 | Centro Internacional para Saude Reprodutiva Mocambique | Maputo | Mozambique |
Sponsors and Collaborators
- King's College London
- Aga Khan University
- Centro Internacional para Saude Reprodutiva Mocambique
- UK Research and Innovation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HR/DP-22/23-39521