Pilot Evaluation of the Thriving Mamas Programme for Adolescent Perinatal Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Intervention Feasibility
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: The Thriving Mamas programme (Other)
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)
干预措施: Usual care (Other)
结局指标
主要结局
Intervention Feasibility
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- Change in adolescent pregnancy attitudes(Baseline and immediately after provider training)
- Change in perception of intervention(Baseline and 10-12 weeks post-partum)
- 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 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 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 breastfeeding(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)