Integrated Parenting Intervention for Parents With Schizophrenia: A Feasibility Randomized Controlled Trial in Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Intervention attendance log
研究概览
简要总结
Evidence reports that parents with schizophrenia are particularly vulnerable to parenting difficulties and also experience problems in sensitively interacting with their children. This may cause insecure attachment in infants of mothers with psychosis. Children of parents with schizophrenia have poor developmental and clinical outcomes. However, there is no published trial, to the best of our knowledge, for children of parents with schizophrenia. Learning through Play (LTP) is a potentially low cost intervention to improve maternal mental health and child outcomes by promoting health child development. The proposed study will integrate LTP with existing culturally appropriate Cognitive Behaviour Theray (CBT) for psychosis (CaCBT-p) and test its feasibility and acceptability for parents with schizophrenia.
详细描述
Objectives
- To determine whether the proposed intervention is acceptable to the parents with schizophrenia.
- To assess the feasibility of proposed intervention for target population (no of sessions attended, content, duration and location, uptake and retention).
- To determine most suitable outcome measures for future randomized controlled trial.
- To identify any barriers in recruitment of participants. Recruiting up to 75% of total sample will be a success criteria.
Methods Design: Mixed method feasibility Randomised Controlled Trial Study Sites The participants will be recruited from outpatient departments of psychiatry and community settings in 7 cities of Pakistan i.e. Karachi, Hyderabad, Lahore, Rawalpindi, Multan, Peshawar and Quetta.
Sample Size:
A total of 90 individuals (45 in each arm) meeting the eligibility criteria will be recruited to participate in the study from different psychiatric units.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic and Statistical Manual-V (DSM-V) diagnosed first episode psychosis, schizophrenia, schizoaffective disorder, psychosis not otherwise specified or schizophreniform disorder.
- •Parents (Mother or Father), age 18 year and above
- •Parents (Mother or Father) having a child from birth to 36 months
- •Parents (Mother or Father) living within the catchment area of recruitment site.
- •Competent and willing to give informed consent
- •Parents (Mother or Father) are stable on medication for at least 3 months prior to the intervention.
排除标准
- •Violation of any inclusion criteria
- •Failure to perform screening or baseline examinations.
- •Patients who will meet the criteria for a DSM-V diagnosis of alcohol or substance abuse (other than for nicotine) within the last month or the criteria for DSM-V alcohol or substance dependence (other than for nicotine) within the last 6 months
- •Temporary resident unlikely to be available for follow up.
结局指标
主要结局
Intervention attendance log
时间窗: number of sessions attended by each participant in 12 month time
This log will be maintained to assess the acceptability of the intervention is defined as "the extent participant receiving the intervention consider it to be appropriate"
Attrition Rate
时间窗: Change in numbers from first month of randomisation to last month of outcome assessments (total time period is 18 months).
The number participants withdrawn out of those consented to participate
Recruitment Rate
时间窗: Change in numbers from first month of recruitment to last month of recruitment (total recruitment period is 12 months)
The number of parent-child dyads referred by the community health workers/treating psychiatrists, the parents who consented from all eligible parent-child dyads
次要结局
- Child Weight(Change in scores from baseline to 3-month post-randomisation)
- Positive and Negative Syndrome Scale(Change in scores from baseline to 3-month post-randomisation)
- Knowledge attitude and practices of Child Development(Change in scores from baseline to 3-month post-randomisation)
- Client Service Receipt Inventory(Change in scores from baseline to 3-month post-randomisation)
- Psychotic Rating Scale(Change in scores from baseline to 3-month post-randomisation)
- Social and Occupational Functioning Scale(Change in scores from baseline to 3-month post-randomisation)
- Euro-Qol 5 Dimensions(Change in scores from baseline to 3-month post-randomisation)
- Ages and Stages Questionnaire(Change in scores from baseline to 3-month post-randomisation)
- Child Height(Change in scores from baseline to 3-month post-randomisation)
- Parenting Stress Index(Change in scores from baseline to 3-month post-randomisation)
- Manchester Assessment of Caregiver-Infant Interaction(Change in scores from baseline to 3-month post-randomisation)
- Child head circumference(Change in scores from baseline to 3-month post-randomisation)
- Maternal Attachment Inventory(Change in scores from baseline to 3-month post-randomisation)
- Calgary Depression Scale(Change in scores from baseline to 3-month post-randomisation)
- Bayley Scale of infant development(Change in scores from baseline to 3-month post-randomisation)