跳至主要内容
临床试验/NCT05171192
NCT05171192已完成不适用

Feasibility Study of a Culturally Adapted Manual Assisted Brief Psychological Intervention (CMAP) Plus Learning Through Play (LTP) for Refugee Mothers with History of Self-harm in Pakistan

Pakistan Institute of Living and Learning4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
4
主要终点
Feasibility measure

研究概览

简要总结

Objectives:

  • To asses the feasibility and acceptability of a culturally adapted manual assisted brief psychological intervention (CMAP) plus Learning through Play (LTP) for refugee mothers with history of self-harm having children 0-33 months. (Integrated intervention called CMAP Plus)
  • To assess if CMAP Plus will reduce the repetition of self-harm in refugee mothers having children aged between 0-33 months.
  • To determine if the intervention improves infant development and maternal attachment.
  • To explore participants experiences with the intervention.

Study design and setting:

This will be a feasibility cluster randomized control trial (cRCT) of culturally adapted CMAP Plus LTP intervention with refugee mothers from Quetta and Peshawar, Pakistan.

Sample size:

We aim to recruit a sample of 80 refugee mothers in the study.

详细描述

Mental health of refugees particularly mothers living in camps or in conflict areas is one of the most important issues needing special attention and intervention. Culturally adapted Manual Assisted brief Psychological intervention (CMAP) utilizes problem solving components within a brief intervention that can be widely utilized in clinical practice in reducing repetition of self-harm in people who had recently self-harmed. Similarly, LTP programme promotes child health by supporting attuned interaction between mother and child, increasing maternal awareness of the physical and emotional needs of young children, and encouraging nurture and attachment. The CMAP plus LTP intervention may contribute significantly to the evidence base of addressing mental health of refugee mothers. This study aims to evaluate whether CMAP Plus LTP is feasible, acceptable for this population and helpful to reduce the repetition of self-harm and improve child development among refugee mothers with a history of self-harm. Eligible consented participants will complete the baseline assessments using structured questionnaires. Unit of randomization will be the Union Council. Uniion councils have been slected by the research team through consultations with community advisory committees from both sites. Selected UCs will be randomized into two study arms: 1) C-MAP plus LTP added to treatment as usual and 2) Treatment as usual (TAU) alone. Participants in intervention arm will receive 10 individual sessions of CMAP plus LTP intervention for a period of 12 weeks. All sessions will be delivered by female therapists trained in CMAP Plus. Participants in TAU alone group will receive routine care that includes routine follow up by Community Health Workers (CHWs) in Pakistan. Assessments will be carried out at baseline, and completion of the intervention at 12th week (after intervention). All assessments will be rater-blind (done by independent RAs (female), not involved in delivering the intervention sessions). After post-assessments, a purposefully selected subset (stratified by age) of participants will be invited for qualitative interviews (n = up to 15 interviews) to explore their experiences and satisfaction with the intervention. On average, interviews will last for 60-90 minutes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 years and above refugee mothers with children aged between 0-33 months.
  • History of self-harm.
  • Resident in the study site.
  • Capacity to provide informed consent.
  • Available for the duration of the study.

排除标准

  • Unable to provide consent due to severe mental or physical illness.
  • Unlikely to be available for the entire duration of the study.

结局指标

主要结局

Feasibility measure

时间窗: From baseline to 12th week (at the end of intervention)

The feasibility will be determined by collating data on recruitment and retention rates. The success criterion of feasibility will be to recruit \> 50% of eligible participants.

Acceptability measure

时间窗: From baseline to 12th week (at the end of intervention)

The intervention acceptability will be assessed using data on attendance. Criterion for acceptability is a mean attendance rate of \>70% of at least 7 sessions.

次要结局

  • Problem Solving Inventory(Change in problem scores from baseline to 12th week)
  • Client Satisfaction Questionnaire(Change from baseline to 12th week)
  • Ages and Stages Questionnaire and ASQ Socio-emotional Scales(Change from baseline to 12th week)
  • Beck Depression Inventory(Change in problem scores from baseline to 12th week)
  • Beck Scale for Suicide Ideation(Change in problem scores from baseline to 12th week)
  • Beck Hopelessness Scale(Change in problem scores from baseline to 12th week)
  • Parenting Stress Index - Short Form(Change from baseline to 12th week)
  • Infant Development Questionnaire(Change from baseline to 12th week)
  • Client Service Receipt Inventory(Change from baseline to 12th week)
  • Assessment of the growth and development of children(Change from baseline to 12th week)
  • Coping resource inventory(Change from baseline to 12th week)
  • Multidimensional Scale of Perceived Social Support(Change from baseline to 12th week)
  • Euro-Qol-5 Dimensions scale(Change in problem scores from baseline to 12th week)
  • Suicide Attempt Self-Injury Interview(From baseline to 12th week)
  • Generalized Anxiety Disorder(Change in problem scores from baseline to 12th week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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