The Preliminary Evaluation of Supporting Addiction Affected Families Effectively (SAFE) - a Contextually Adapted Intervention to Support Family Members Affected by a Relative's Alcohol Use: a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Symptom Rating Test
研究概览
简要总结
Background: Burden in addiction-affected families is a huge problem (well over 100 million family members worldwide are affected by substance use of a relative), largely unrecognised and untreated. Affected family members (AFMs) are vulnerable to physical and mental ill-health, reduced quality of relationships in the family, and family violence. In India, the burden of alcohol use is increasing: attitudes regarding alcohol use and alcohol availability, consumption patterns, age of drinking onset, levels of heavy drinking and alcohol-related problems, are all changing for the worse. These changes to levels of alcohol consumption and problems will have caused a corresponding increase in the prevalence of AFMs, although they are largely a hidden group. Yet, despite clear evidence of the burden of alcohol use on families, there is a lack of adequate support and targeted services for them. The objective of our study is to examine the preliminary effectiveness, feasibility and acceptability of Supporting Addiction Affected Families Effectively (SAFE) versus Enhanced Usual Care (EUC) in improving clinical outcomes.
Methods: Our study is a parallel arm Pilot Randomised Controlled Trial of a psychosocial intervention for family members affected by a relative's alcohol use, in Goa, India. 100 AFMs will be recruited by referrals from community gatekeepers and professionals, and self-referrals resulting from media coverage of the study and and word-of-mouth publicity. Those who consent will be allocated in a 1:1 ratio to receive either SAFE (counselling) or EUC (information sheet). SAFE will be delivered by lay counsellors over 5 sessions spread across a month and a half, and EUC will consist of an information sheet on alcohol use, its nature, impact and treatment. The primary outcome is mean difference in 'symptoms' scores assessed by the Symptom Rating Test (at 3 months). Secondary outcomes are mean differences in 'coping' scores assessed by the Coping Questionnaire, 'impact' scores assessed by the Family Member Impact Questionnaire, and 'support' scores assessed by the Alcohol, Drugs and the Family Social Support Scale (at 3 months). The primary analyses will be intention-to-treat at the 3-month end-point.
Discussion: Our study will aid the process of translational research, by adopting frameworks that have an established evidence base, and implementing these frameworks in a culturally appropriate manner to newer underserved populations.
详细描述
Rationale:
Well over 100 million family members worldwide are affected by the addictive behaviour (alcohol, drugs, etc.) of a relative, which has a highly stressful impact on these affected family members (AFMs). Although AFMs may not suffer from a diagnosable mental health condition, their experiences of living with a drinker makes them vulnerable to physical and mental ill-health, including mood and substance use disorders, trauma, and stress related conditions. Studies in India on the impact of substance use demonstrate high burden in AFMs, disruptions in family routine, finances, interactions and leisure, and spouses being 'worried about their husband's habits', primarily alcohol consumption. Using evidence-based interventions, AFMs can be helped to reduce their symptoms and improve methods of coping. One such intervention is the 5-Step Method (developed in the UK) and is being used in developed countries, with studies demonstrating significant positive effects. Supporting Addiction Affected Families Effectively (SAFE) is a research project to contextually adapt the 5-Step Method (in India). The project entails a Pilot Randomised Controlled Trial (RCT) evaluating SAFE delivered by lay counsellors in comparison with Enhanced Usual Care (EUC). The study involves preliminary testing of the intervention consistent with the pre-evaluation phase of the Medical Research Council's framework for complex interventions.
Research questions:
The objectives of the study are to evaluate the effectiveness, feasibility and acceptability of the SAFE intervention, for family members affected by a relative's alcohol use, in Goa, India. Corresponding to these objectives, the research questions in the primary research publication are: 1. Primary question: a) Is the SAFE intervention superior to EUC in reducing psychological and physical symptoms in family members affected by a relative's alcohol use, at 3 months' post enrolment? 2. Secondary questions: a) Is the SAFE intervention superior to EUC in reducing coping behaviors in family members affected by a relative's alcohol use, at 3 months' post enrolment? b) Is the SAFE intervention superior to EUC in reducing impact on family members affected by a relative's alcohol use, at 3 months' post enrolment? c) Is the SAFE intervention superior to EUC in improving social support for family members affected by a relative's alcohol use, at 3 months' post enrolment? The research questions in the secondary research publication are: a) What are the treatment experiences of the family members affected by a relative's alcohol use? b) What is the preliminary feasibility of the SAFE intervention, delivered by lay counsellors to family members affected by a relative's alcohol use? c) What is the acceptability of the SAFE intervention, delivered by lay counsellors to family members affected by a relative's alcohol use?
Design:
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
- Double (Investigator, 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
- 是
入选标准
- •Age (18 years of age and above).
- •Family member reports that the relative's drinking has been a major source of distress (to themselves or to others, in the family or outside) in the previous six months.
- •Family member and the relative who has been consuming alcohol have been living in the same house at some point in the previous six months, or had regular contact.
- •Family member is able to understand and speak any of the local vernacular languages (Konkani, Marathi, Hindi) or English.
- •Family member does not have substance use-related problems.
- •Family member does not have a severe physical or mental health problem that requires urgent treatment and/ or may interfere with participation in the program.
- •Family member is a resident of the catchment area for the duration of the program.
排除标准
- •Age (less than 18 years of age).
- •Family member does not report that the relative's drinking has been a major source of distress (to themselves or to others, in the family or outside) in the previous six months.
- •Family member and the relative who has been consuming alcohol have not been living in the same house at some point in the previous six months, or not had regular contact.
- •Family member is not able to understand and speak any of the local vernacular languages (Konkani, Marathi, Hindi) or English.
- •Family member has substance use-related problems.
- •Family member has a severe physical or mental health problem that requires urgent treatment and/ or may interfere with participation in the program.
- •Family member is not a resident of the catchment area for the duration of the program.
研究组 & 干预措施
Counselling
Supporting Addiction Affected Families Effectively is a contextually adapted version of the 5-Step Method, a psychosocial intervention based on the principles of the Stress-Strain-Coping-Support model. The intervention is manualised, and is delivered by lay counsellors over 5 sessions at a weekly basis. The 5 steps (covered in the 5 steps) include: 1) Exploring stresses and strains, 2) Providing relevant information, 3) Exploring and discussing coping behaviours, 4) Exploring and enhancing social support, and 5) Exploring additional needs, and further sources of help. The intervention is delivered in settings based on convenience of the participant: which might be a place outside the home (e.g. field office, neighbour's home), or the participant's home.
干预措施: Supporting Addiction Affected Families Effectively (Other)
Enhanced Usual Care
In the study setting, usual care for affected family members is no care at all, as detection rates of stress/strain in affected family members are extremely low. Hence, Enhanced Usual Care for the control group consists of a minimal intervention, namely a leaflet. The leaflet focuses on the burden that affected family members experience in relation to a relative who drinks alcohol, and on various informal and formal sources of support that are available in the local community.
干预措施: Enhanced Usual Care (Other)
结局指标
主要结局
Symptom Rating Test
时间窗: 3 months
* Full Scale Name: Symptom Rating Test (Kellner \& Sheffield, 1973; Orford et al, 2005, 2010a). * Construct: This scale measures physical and psychological symptoms; conceptualized as 'Strain' within the Stress-Strain-Coping-Support Model (the model underlying the SAFE project - Orford et al, 2010b). * Total scale range: Total symptom score (min.= 0 max.= 60) * Sub scale range: Total psychological symptom score (min.= 0 max.= 36) and total physical symptom score (min.= 0 max.= 24) * Higher values represent higher symptoms - i.e. worse outcomes * Subscales are combined by summing.
次要结局
- Family Member Impact Questionnaire(3 months)
- Coping Questionnaire(3 months)
- Alcohol, Drugs and the Family Social Support Scale(3 months)