Ignite Creation Date:
2024-05-06 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03412669
Status:
COMPLETED
Last Update Posted:
2018-05-02
First Post:
2018-01-21
Brief Title:
The Preliminary Evaluation of Supporting Addiction Affected Families Effectively
Sponsor:
Sangath
Organization:
Sangath
Study Overview
Official Title:
The Preliminary Evaluation of Supporting Addiction Affected Families Effectively SAFE - a Contextually Adapted Intervention to Support Family Members Affected by a Relatives Alcohol Use a Pilot Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 relatives 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 11 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
Methods Our study is a parallel arm Pilot Randomised Controlled Trial of a psychosocial intervention for family members affected by a relatives 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 11 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
Detailed Description:
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 husbands 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 Councils 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 relatives 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 relatives 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 relatives alcohol use at 3 months post enrolment b Is the SAFE intervention superior to EUC in reducing impact on family members affected by a relatives 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 relatives 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 relatives alcohol use b What is the preliminary feasibility of the SAFE intervention delivered by lay counsellors to family members affected by a relatives alcohol use c What is the acceptability of the SAFE intervention delivered by lay counsellors to family members affected by a relatives alcohol use
Design
Parallel arm single blind pilot RCT of the SAFE intervention compared with EUC for family members affected by their relatives alcohol use in Goa and a nested qualitative study 50 AFMs each will be recruited in the intervention and control groups
Study setting and target population
The study will be conducted in Goa India population14 million people Unlike most of India Goa has easily available and cheap alcoholic drinks and a more liberal wet culture towards drinking and this is reflected in lower abstinence rates The prevalence of current drinking past one year in Goa amongst men from the community is 39 amongst primary care male attenders is 59 and amongst male industrial workers is 69 The target population includes family members eg parents spousepartner siblings grandparents affected by their relatives drinking
Recruitment
AFMs will be recruited by 1 referrals from community gatekeepers eg community health workers self-help group members village council members 2 referrals from professionals who come into contact with people with alcohol-related problems or their AFMs eg psychiatrists priests and 3 self-referrals resulting from media eg advertisements and word-of-mouth publicity Once the AFM is referred or identified there will be an initial meeting during which the lay counsellors will implement the following procedures 1 Confirm participant eligibility to enter the trial 2 Obtain informed consent 3 Administer baseline assessments and 4 Assign participants to either SAFE or EUC based on the randomisation list
Baseline measures
Baseline measures include 1 Socio-demographic questionnaire 2 Symptom Rating Test SRT assessing the extent of mild-to-moderate physical and psychological ill heath 3 Coping Questionnaire CQ measuring ways of coping in the AFM 4 Family Member Impact Questionnaire FMI measuring extent and type of impact on the AFM and 5 Alcohol Drugs and the Family Social Support Scale ADF-SSS assessing the perceived functional social support needs of AFMs The SRT CQ FMI ADF-SSS have been selected as they have been used in other studies exploring the 5-Step Method have developed from decades of work with AFMs and measure the key underpinning theoretical constructs in the Stress-Strain-Coping-Support model on which the 5-Step Method is based All these measures have been validated previously and will have undergone adaptation for use in the local context during the ongoing formative research
Randomisation
Consenting eligible participants will be randomized to receive the intervention or EUC An independent data manager will generate a randomisation list to avoid any bias in treatment allocation Research assistants will use Sequentially Numbered Opaque Sealed Envelopes to randomize the participants individually to maximize allocation concealment
Intervention and Enhanced Use Care
The intervention to be tested will be a contextually adapted version of the 5-Step Method which is based on the principles of the Stress-Strain-Coping-Support model The 5 steps include 1 Exploring stresses and strains 2 Providing relevant information 3 Exploring and discussing coping behaviors 4 Exploring and enhancing social support and 5 Ending sessions and exploring additional needs and further sources of help The intervention will be delivered in settings based on convenience of the participant home health centre etc In the study setting usual care for AFM is no care at all as detection rates are extremely low EUC for the control group includes an information leaflet on the nature and impact of alcohol use and existing treatment options for AFMs
Interventionists
SAFE will be delivered by lay counsellors ie community members with no mental health qualifications Eligible lay counsellors will undergo rigorous training and supervision in the delivery of the intervention and only those who achieve pre-determined competency standards will be selected to deliver the intervention
Outcomes and process indicators
The effectiveness of the intervention will be assessed at 3 months through the primary outcome measures SRT and secondary outcome measures CQ ADF-SSS and FMI administered by research assistants Process indicators will be collated including number of patients screened and completing the intervention number frequency and duration of intervention sessions and number of lay counsellors trained and achieving competency
Nested qualitative study
The qualitative study is to explore AFMs experiences of SAFE and its perceived impact and lay counsellors experiences in delivering SAFE The primary methods of qualitative data collection will be in-depth interviews and focus group discussions The participants for the qualitative study will be recruited after the completion of the end-point assessments of the study utilising a purposive and maximum variation sampling strategy
Strategies to minimise bias
The investigators and research staff will be blind to the treatment allocation The following procedures will be implemented to ensure blinding 1 The 3-month outcome assessments will be administered by research assistants who will have had no previous engagement in the study and will be blind to the treatment allocation to avoid bias in the assessment of the outcomes 2 To minimise unmasking a the primary outcome assessment will be administered prior to all other assessments b during the training of the research assistants it will be emphasised that there is genuine scientific equipoise about the intervention versus EUC c participants will be requested not to disclose their allocation status to the research assistants during the assessment 3 The baseline data will be anonymised during the analysis stage During the study the blind may be broken in circumstances where the participant experiences any harmrisk of harm and knowledge of the treatment allocation status is crucial for further management
Analyses
Baseline comparability of randomized groups Baseline characteristics of enrolled participants will be compared between treatment arms and overall summarized using mean and standard deviation median and interquartile range or numbers and proportions as appropriate
Outcome analyses STATA will be used for data description and the main inferential analysis The primary analyses will be intention-to-treat at the 3-month end-point Any missing outcome data will be imputed by multiple imputation using baseline characteristics on STATA Secondary analyses at the 3-month end point be complete case analyses adjusted for baseline values associated with drop out from outcome evaluation
Process evaluation Process evaluation will be used to assess quality of implementation in the trial and identify contextual factors associated with variation in outcomes Process indicators will be summarized in a CONSORT flow chart which will include recruitment and consent rates Initial analyses will compare baseline characteristics of individuals who consented and did not consent and participants who completed outcome assessments and did not complete assessments The routine monitoring data will be summarised in a descriptive manner
Qualitative analysis The qualitative data from interviews will be coded independently by two researchers and themes will be identified and further analysed using the thematic analysis framework
Overall the data arising from the outcome and process evaluations will be triangulated for a comprehensive understanding of the study data
Host institute
Sangath Goa is the coordinating centre for the study httpwwwsangathcomindexphp Sangath is a community-based Non-Governmental Organisation working across various states in India on research in mental health problems across the lifespan Sangath has achieved global recognition in mental health research given its focus on innovative solutions in mental health care in low resource settings and has a track record of conducting successful psychosocial intervention-based RCTs
Ethics
The study is planned conducted and reported in accordance with the Helsinki Declaration and Good Clinical Practice guidelines Ethical approval has been sought from the Sangath Institutional Review Board IRB and the Indian Council of Medical Research ICMR
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 husbands 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 Councils 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 relatives 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 relatives 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 relatives alcohol use at 3 months post enrolment b Is the SAFE intervention superior to EUC in reducing impact on family members affected by a relatives 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 relatives 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 relatives alcohol use b What is the preliminary feasibility of the SAFE intervention delivered by lay counsellors to family members affected by a relatives alcohol use c What is the acceptability of the SAFE intervention delivered by lay counsellors to family members affected by a relatives alcohol use
Design
Parallel arm single blind pilot RCT of the SAFE intervention compared with EUC for family members affected by their relatives alcohol use in Goa and a nested qualitative study 50 AFMs each will be recruited in the intervention and control groups
Study setting and target population
The study will be conducted in Goa India population14 million people Unlike most of India Goa has easily available and cheap alcoholic drinks and a more liberal wet culture towards drinking and this is reflected in lower abstinence rates The prevalence of current drinking past one year in Goa amongst men from the community is 39 amongst primary care male attenders is 59 and amongst male industrial workers is 69 The target population includes family members eg parents spousepartner siblings grandparents affected by their relatives drinking
Recruitment
AFMs will be recruited by 1 referrals from community gatekeepers eg community health workers self-help group members village council members 2 referrals from professionals who come into contact with people with alcohol-related problems or their AFMs eg psychiatrists priests and 3 self-referrals resulting from media eg advertisements and word-of-mouth publicity Once the AFM is referred or identified there will be an initial meeting during which the lay counsellors will implement the following procedures 1 Confirm participant eligibility to enter the trial 2 Obtain informed consent 3 Administer baseline assessments and 4 Assign participants to either SAFE or EUC based on the randomisation list
Baseline measures
Baseline measures include 1 Socio-demographic questionnaire 2 Symptom Rating Test SRT assessing the extent of mild-to-moderate physical and psychological ill heath 3 Coping Questionnaire CQ measuring ways of coping in the AFM 4 Family Member Impact Questionnaire FMI measuring extent and type of impact on the AFM and 5 Alcohol Drugs and the Family Social Support Scale ADF-SSS assessing the perceived functional social support needs of AFMs The SRT CQ FMI ADF-SSS have been selected as they have been used in other studies exploring the 5-Step Method have developed from decades of work with AFMs and measure the key underpinning theoretical constructs in the Stress-Strain-Coping-Support model on which the 5-Step Method is based All these measures have been validated previously and will have undergone adaptation for use in the local context during the ongoing formative research
Randomisation
Consenting eligible participants will be randomized to receive the intervention or EUC An independent data manager will generate a randomisation list to avoid any bias in treatment allocation Research assistants will use Sequentially Numbered Opaque Sealed Envelopes to randomize the participants individually to maximize allocation concealment
Intervention and Enhanced Use Care
The intervention to be tested will be a contextually adapted version of the 5-Step Method which is based on the principles of the Stress-Strain-Coping-Support model The 5 steps include 1 Exploring stresses and strains 2 Providing relevant information 3 Exploring and discussing coping behaviors 4 Exploring and enhancing social support and 5 Ending sessions and exploring additional needs and further sources of help The intervention will be delivered in settings based on convenience of the participant home health centre etc In the study setting usual care for AFM is no care at all as detection rates are extremely low EUC for the control group includes an information leaflet on the nature and impact of alcohol use and existing treatment options for AFMs
Interventionists
SAFE will be delivered by lay counsellors ie community members with no mental health qualifications Eligible lay counsellors will undergo rigorous training and supervision in the delivery of the intervention and only those who achieve pre-determined competency standards will be selected to deliver the intervention
Outcomes and process indicators
The effectiveness of the intervention will be assessed at 3 months through the primary outcome measures SRT and secondary outcome measures CQ ADF-SSS and FMI administered by research assistants Process indicators will be collated including number of patients screened and completing the intervention number frequency and duration of intervention sessions and number of lay counsellors trained and achieving competency
Nested qualitative study
The qualitative study is to explore AFMs experiences of SAFE and its perceived impact and lay counsellors experiences in delivering SAFE The primary methods of qualitative data collection will be in-depth interviews and focus group discussions The participants for the qualitative study will be recruited after the completion of the end-point assessments of the study utilising a purposive and maximum variation sampling strategy
Strategies to minimise bias
The investigators and research staff will be blind to the treatment allocation The following procedures will be implemented to ensure blinding 1 The 3-month outcome assessments will be administered by research assistants who will have had no previous engagement in the study and will be blind to the treatment allocation to avoid bias in the assessment of the outcomes 2 To minimise unmasking a the primary outcome assessment will be administered prior to all other assessments b during the training of the research assistants it will be emphasised that there is genuine scientific equipoise about the intervention versus EUC c participants will be requested not to disclose their allocation status to the research assistants during the assessment 3 The baseline data will be anonymised during the analysis stage During the study the blind may be broken in circumstances where the participant experiences any harmrisk of harm and knowledge of the treatment allocation status is crucial for further management
Analyses
Baseline comparability of randomized groups Baseline characteristics of enrolled participants will be compared between treatment arms and overall summarized using mean and standard deviation median and interquartile range or numbers and proportions as appropriate
Outcome analyses STATA will be used for data description and the main inferential analysis The primary analyses will be intention-to-treat at the 3-month end-point Any missing outcome data will be imputed by multiple imputation using baseline characteristics on STATA Secondary analyses at the 3-month end point be complete case analyses adjusted for baseline values associated with drop out from outcome evaluation
Process evaluation Process evaluation will be used to assess quality of implementation in the trial and identify contextual factors associated with variation in outcomes Process indicators will be summarized in a CONSORT flow chart which will include recruitment and consent rates Initial analyses will compare baseline characteristics of individuals who consented and did not consent and participants who completed outcome assessments and did not complete assessments The routine monitoring data will be summarised in a descriptive manner
Qualitative analysis The qualitative data from interviews will be coded independently by two researchers and themes will be identified and further analysed using the thematic analysis framework
Overall the data arising from the outcome and process evaluations will be triangulated for a comprehensive understanding of the study data
Host institute
Sangath Goa is the coordinating centre for the study httpwwwsangathcomindexphp Sangath is a community-based Non-Governmental Organisation working across various states in India on research in mental health problems across the lifespan Sangath has achieved global recognition in mental health research given its focus on innovative solutions in mental health care in low resource settings and has a track record of conducting successful psychosocial intervention-based RCTs
Ethics
The study is planned conducted and reported in accordance with the Helsinki Declaration and Good Clinical Practice guidelines Ethical approval has been sought from the Sangath Institutional Review Board IRB and the Indian Council of Medical Research ICMR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None