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| Name | Class |
|---|---|
| Aga Khan University | OTHER |
| Centro Internacional para Saude Reprodutiva Mocambique | UNKNOWN |
| UK Research and Innovation | OTHER |
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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thriving Mama programme | Experimental | 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. |
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| Usual perinatal care | Active Comparator | Each visit includes care that is appropriate to the overall condition and stage of pregnancy and should include four main categories of care:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Thriving Mamas programme | Other | Enhanced antenatal course plus usual perinatal care |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Khan University | Nairobi | Kenya | ||||
| Centro Internacional para Saude Reprodutiva Mocambique |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40537871 | Derived | Taylor Salisbury T, Maguele MSB, Chissale F, de Melo M, Hanselmann M, Lamahewa K, Lang'at E, Mandlate F, Nyaga L, Seward N, Temmerman M. Supporting the mental health of adolescent mothers in Kenya and Mozambique: pilot protocol for the Thriving Mamas programme. Pilot Feasibility Stud. 2025 Jun 19;11(1):83. doi: 10.1186/s40814-025-01617-5. |
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| Usual care | Other | Usual perinatal care |
|
| 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 |
| Maputo |
| Mozambique |