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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
141
Enhanced antenatal course plus usual perinatal care
Usual perinatal care
Aga Khan University
Nairobi, Kenya
Centro Internacional para Saude Reprodutiva Mocambique
Maputo, Mozambique
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through intervention delivery, an average of 24 weeks
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Immediately after provider training
Recruitment rate
Proportion of adolescents providing consent to participate in the study
Time frame: pre-intervention
Cost of intervention
Total and average cost of the intervention per participant
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: through study completion, an average of 24 weeks
Perinatal appointment attendance
Number of participants attending antenatal appointments
Time frame: through study completion, an average of 24 weeks
Referral uptake
Proportion of adolescents attending referral appointments
Time frame: 10-12 weeks post-partum
Change in infant vaccination
Number of participants intending to or having had their babies vaccinated
Time frame: Baseline and 10-12 weeks post-partum
Change in breastfeeding
Number of participants intendng to or are currently breastfeeding
Time frame: 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
Time frame: Baseline and 10-12 weeks post-partum
Change in contraceptive use
Number of participants intending to or currently using contraceptives to delay pregnancy
Time frame: 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
Time frame: Baseline and 10-12 weeks post-partum
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