Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583356
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-01
Brief Title:
Motivational Interviewing Intervention For Risky Drinking Treatment Among Indigenous Population
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Adaptation and Effectiveness of Motivational Interviewing Intervention For Risky Drinking Treatment Among Indigenous Population Protocol For A Single-arm Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIRDIP
Brief Summary:
The goal of this single-arm trial is to adapt and evaluate the effectiveness of motivational interviewing intervention for treating risky drinking behaviour among indigenous population in Pahang Malaysia
To achieve this the investigators will
i Translate 3 questionnaires regarding alcohol consumption from English into Jakun language a language of one of Malaysiaampampamp39s indigenous communities ii Adapt a motivational interviewing intervention for treatment of risky drinking for this community iii Implement the intervention and measure its outcomes using the translated questionnaires
Participants will
i Answer translated questionnaires during the validation of questionnaires phase 1 ii Receive 3 sessions of motivational interviewing phase 2
To achieve this the investigators will
i Translate 3 questionnaires regarding alcohol consumption from English into Jakun language a language of one of Malaysiaampampamp39s indigenous communities ii Adapt a motivational interviewing intervention for treatment of risky drinking for this community iii Implement the intervention and measure its outcomes using the translated questionnaires
Participants will
i Answer translated questionnaires during the validation of questionnaires phase 1 ii Receive 3 sessions of motivational interviewing phase 2
Detailed Description:
Alcohol consumption particularly in the form of harmful alcohol use has long posed substantial public health challenges It has been proven to cause multitude health problems including non-communicable diseases injuries and increased risk of communicable diseases Rehm et al 2017 Room et al 2005 Globally it is estimated there are 26 million deaths annually as a result of the harmful alcohol use WHO 2024
Risky drinking is defined as the level of alcohol consumption that is associated with negative consequences such as health problems accidents and social issues Karlsson et al 2023 It is defined as Alcohol Use Disorders Identification Test AUDIT-10 score of more or equal to 8 Institute for Public Health 2020 O39Donnell et al 2018
Indigenous community in the Peninsular Malaysia is a member of an aboriginal ethnic group who speaks an aboriginal language and habitually follows an aboriginal way of life customs and beliefs Malaysian government 1954 Among this community alcohol consumption has long been associated with a tradition during festivals or after a good harvest season Ali et al 1991 Nevertheless studies have found that the prevalence of alcohol consumption among indigenous populations in Malaysia varies from as low as 71 to as high as 348 Ahmad et al 2013 Chua et al 2017 Ithnin et al 2020 Yusof et al 2007 with the most consumed alcohol beverage is beer Abd Rashid et al 2010
Globally while indigenous populations are more likely to abstain from alcohol they are more likely to progress to risky drinking resulting in alcohol-related health consequences Andersen et al 2021 Delker et al 2016 Gray et al 2018 Possible reasons may include socioeconomic disparities perceived discrimination and marginalisation Camacho-Martínez et al 2023 cultural disconnection Werito amp Belone 2021 community and social factors Conigrave et al 2021 and a lack of access to culturally sensitive health services Kelaher et al 2012 Furthermore a study in Malaysia revealed that alcohol consumption among the indigenous community was primarily driven by stress management strategy and social factors Ithnina et al 2020
There are several approaches in risky drinking intervention namely pharmacological psychological and social support dampampamp39Abbs et al 2013 Psychological intervention is found to be the most active and studied approach among indigenous populations d39Abbs et al 2013 Purcell-Khodr et al 2020 This includes brief intervention motivational interviewing and cognitive behavioural therapy Andersen et al 2021 d39Abbs et al 2013 Purcell-Khodr et al 2020
Motivational interviewing is a counselling method to enhance motivation through resolution of ambivalence Hall et al 2012 It is a client-oriented counselling style Miller amp Rollnick 2012 emphasising on a collaborative and non-confrontational approach Hettema et al 2005
Presently the only available psychological intervention on risky drinking in Malaysia is predominantly based on standard brief intervention designed for the general population which prioritises imparting information and telling patients what to do In addition there is a lack of evaluation on the effectiveness of alcohol psychological intervention among indigenous populations in Malaysia especially those that are tailored to their cultural and environmental context Therefore there is a need to adapt an intervention grounded in motivational interviewing and its effectiveness be tested to address the issue of risky drinking among these populations
The objective of this study is to adapt and evaluate the effectiveness of MI intervention for treating risky drinking behaviour among indigenous population in the state of Pahang Malaysia
This study will be divided into 2 phases
i Phase 1 which consists of the translation and validation of questionnaires and the development of motivational interviewing intervention for risky drinking treatment ii Phase 2 the single-arm trial
Phase 1 translation and validation of questionnaires
Several questionnaires regarding the trial outcomes will need to be translated from English into Jakun the language of the indigenous tribe where the trial will take place
Questionnaires to be translated and validated are i Readiness to Change Questionnaire Revised Version RCQ ii Motivation Thought Frequency Scales for Alcohol MTF-A iii Brief Alcohol Abstinence Self-Efficacy 12-Item AASE Scale
The process of translation and backtranslation are performed by 2 medical experts and 2 language experts The selection of 2 medical experts is performed using purposive sampling medical professionals of Jakun origin with experience working in Rompin district Pahang Malaysia The selection of 2 language experts is performed using purposive sampling as well individuals of Jakun descent in Rompin district who are well-versed in both English and Jakun language but not knowledgeable about medical terminology
The harmonised version will undergo face validation among respondents who are selected randomly from RPS Kedaik the site for the questionnaire validation
Method to select participants for face validation From the spot map of the settlement numbers will be assigned to each house Simple random sampling will be performed using computer-generated random numbers A representative from the selected house will be invited to be a respondent
The resulting finalised version of RCQ-JK MTF-A-JK and AASE-JK will undergo a reliability and validation study From the spot map of the settlement numbers will be assigned to each house Simple random sampling will be performed using computer-generated random numbers A representative from the selected house will be screened ie age 18 years old who is a current drinker Those who fulfill these criteria will be invited to join the study
During informed consent process individual will be briefed using the simple Malay language with patient information sheet which is available in Jakun language as the guide to ensure understanding Individuals who cannot read can be represented by reliable kin or legally authorised representative
Phase 1 adaptation of motivational interviewing intervention for risky drinking treatment
This process will be guided by ADDIE Model analysis design development implementation and evaluation
In analysis phase a literature review will be conducted from which evidence are collected to inform the content development process eg published articles manuals guidelines
In design phase findings from the previous literature review will be discussed with a panel of experts using Nominal Group Technique There will be 4 experts selected using purposive sampling which include a public health medicine specialist a psychologist with certificate in motivational interviewing a researcher specialised in health promotion and a medical assistant in the local health clinic who is of Jakun descent The facilitator primary investigator will summarise the scores to ascertain the overall group priorities
In development phase the content derived from the previous 2 phases will be developed into a module for motivational interviewing intervention
At the end of content development content validity will be assessed by obtaining ratings from each member of the expert panel with regards to its relevance clarity simplicity and ambiguity Additionally there would also be content and face validation by another panel of expert
Implementation and evaluation phases will be conducted during the subsequent single-arm trial
Phase 2 single-arm trial
This trial will be conducted at another indigenous settlement located close to the one in previous phase called Kampung Jemeri
Sampling methods From the spot map of the settlement numbers will be assigned to each house Simple random sampling will be performed using computer-generated random numbers A representative from the selected house will be approached and explained about the study
During informed consent process individual will be briefed using simple Malay language with patient information sheet which is available in Bahasa Jakun as the guide to ensure understanding Individuals who cannot read can be represented by reliable kin or legally authorised representative If the individual agrees heshe will be screened using AUDIT-10 questionnaire Those with AUDIT-10 score between 8 and 19 will subjected to further eligibility criteria refer inclusion and exclusion criteria for Phase 2 Those who fulfill these criteria will be invited to join the study Those who do not fulfill these criteria will be thanked and will not be enrolled in the study
Measurement and data collection Participants information will be collected at 1st visit right after 1st intervention 6 weeks post-intervention and 3 months post-intervention
Why measurement is performed at immediately after 1st intervention 6 weeks and 3 months post-intervention A systematic review of reviews by Frost et al 2018 revealed consistent evidence on beneficial effect of motivational interview on alcohol consumption for short term outcomes less than 4 months but less consistent evidence on sustained more than 4 months outcomes Furthermore a systematic review and meta-analysis by Lundahl et al 2018 measuring the effect size of motivational interviewing indicated that between immediate and 1 month time frame after intervention MI impact shows odds ratio of 138 Between 5 weeks to 6 months odds ratio increases to 172 The odds ratio drops to 134 after 7 to 12 months of intervention aspect of the follow-up process
Strategies to increase participant retention include telephone contact to participants and In-person visits to participants homes Given that the follow-up will be conducted face-to-face reaching the participants at their residences is essentially crucial
Sample size calculation For face validation the sample size would be 10 Based on Sousa ampamp Rojjanasrirat 2011 who recommended a sample size of 10 to 40 for a pilot testing during the translation adaptation and validation of instruments for use in cross-cultural health care research
For assessment of reliability internal consistency - Cronbachs alpha and construct validity exploratory factor analysis EFA a sample size of 200 will be used
This recommendation is based on the work of Mokkink et al 2019 which suggests that for assessing internal consistency a minimum sample size of 100 is recommended For factor analysis the guideline is to have at least 7 times the number of items with a minimum sample size of 100 Given that each questionnaire has 12 items the ideal sample size would be 12 items 7 84 However since 100 is the minimum requirement the larger sample size of 100 should be used for both internal consistency and factor analysis
However to achieve more reliable results MacCallum et al 1999 suggested a larger sample between 100 and 200 in case of communalities around 05 Hence a sample size of 200 will be used
For further assessment of construct validity confirmatory factor analysis CFA a further sample size of 300 will be used This is based on Mokkink et al 2019 which proposes 7 times number of items for factor analysis with minimum 100 However to achieve more reliable results MacCallum et al 1999 suggested a larger sample of 300 in case of low communalities
For the Phase 2 single-arm trial the sample size calculation is performed using the equation from paired or matched groups for clinical studies Machin et al 2011
A study by Zatzick et alZatzick et al 2014 noted reduction of 18 95 CI 11 24 in AUDIT-10 score after 6 months following an MI intervention on 409 subjects
To calculate the standard deviation CI 196 x Standard error SE 18 - 11 196 x SE SE 0357 SE SD Sample size 0357 SD 409 Standard deviation SD 0357 x 409 722
Width of 95 CI ω 24 - 11 13 Anticipated standard deviation σPlan 722 ΛPlan ω σPlan 13 18 0722
Subsequently the sample size calculation is performed using the above equation yielding a sample size of 2948 which is rounded to 30
This is further confirmed by the table proposed by Machin et alMachin et al 2011 Where ΛPlan between 070 and 075 which gives m at 95 confidence interval between 55 and 63 When NPairs m2 the sample size would be between 275 and 315
Accounting for risk for lost to follow-up additional 20 will be recruited based on previous studies Gaume et al 2022 Jayaraj et al 2012 Therefore the minimum sample size would be 36
Exit strategy
Any participant who is found to have any of the following condition will require proper referral to the relevant medical personnel eg psychiatrist hospital i Serious mental illness previously undiagnosed ii Suspected to have alcohol dependence as evidence by AUDIT-10 score 20 iii Any serious adverse event such as one that is life-threatening or require hospitalisation iv Inability to continue participating in the study due to medical reason
Ethical consideration This study requires approval from the Faculty Ethics Review Committee Faculty of Medicine MARA University of Technology UiTM Malaysia and registration with National Medical Research Register NMRR Malaysia Permission from the Department of Indigenous People Development JAKOA is also required Data collection will only be initiated once the above approvals are obtained
Informed consent process will be conducted prior to inclusion using simple Malay language with patient information sheet which is available in Bahasa Jakun as the guide ensuring that individuals are provided with comprehensive information about the study Participants will be informed that their involvement is voluntary and they have the right to withdraw from the study at any time without repercussion
The counseling session will be conducted one-on-one in a designated area within the participants home to ensure privacy
Risky drinking is defined as the level of alcohol consumption that is associated with negative consequences such as health problems accidents and social issues Karlsson et al 2023 It is defined as Alcohol Use Disorders Identification Test AUDIT-10 score of more or equal to 8 Institute for Public Health 2020 O39Donnell et al 2018
Indigenous community in the Peninsular Malaysia is a member of an aboriginal ethnic group who speaks an aboriginal language and habitually follows an aboriginal way of life customs and beliefs Malaysian government 1954 Among this community alcohol consumption has long been associated with a tradition during festivals or after a good harvest season Ali et al 1991 Nevertheless studies have found that the prevalence of alcohol consumption among indigenous populations in Malaysia varies from as low as 71 to as high as 348 Ahmad et al 2013 Chua et al 2017 Ithnin et al 2020 Yusof et al 2007 with the most consumed alcohol beverage is beer Abd Rashid et al 2010
Globally while indigenous populations are more likely to abstain from alcohol they are more likely to progress to risky drinking resulting in alcohol-related health consequences Andersen et al 2021 Delker et al 2016 Gray et al 2018 Possible reasons may include socioeconomic disparities perceived discrimination and marginalisation Camacho-Martínez et al 2023 cultural disconnection Werito amp Belone 2021 community and social factors Conigrave et al 2021 and a lack of access to culturally sensitive health services Kelaher et al 2012 Furthermore a study in Malaysia revealed that alcohol consumption among the indigenous community was primarily driven by stress management strategy and social factors Ithnina et al 2020
There are several approaches in risky drinking intervention namely pharmacological psychological and social support dampampamp39Abbs et al 2013 Psychological intervention is found to be the most active and studied approach among indigenous populations d39Abbs et al 2013 Purcell-Khodr et al 2020 This includes brief intervention motivational interviewing and cognitive behavioural therapy Andersen et al 2021 d39Abbs et al 2013 Purcell-Khodr et al 2020
Motivational interviewing is a counselling method to enhance motivation through resolution of ambivalence Hall et al 2012 It is a client-oriented counselling style Miller amp Rollnick 2012 emphasising on a collaborative and non-confrontational approach Hettema et al 2005
Presently the only available psychological intervention on risky drinking in Malaysia is predominantly based on standard brief intervention designed for the general population which prioritises imparting information and telling patients what to do In addition there is a lack of evaluation on the effectiveness of alcohol psychological intervention among indigenous populations in Malaysia especially those that are tailored to their cultural and environmental context Therefore there is a need to adapt an intervention grounded in motivational interviewing and its effectiveness be tested to address the issue of risky drinking among these populations
The objective of this study is to adapt and evaluate the effectiveness of MI intervention for treating risky drinking behaviour among indigenous population in the state of Pahang Malaysia
This study will be divided into 2 phases
i Phase 1 which consists of the translation and validation of questionnaires and the development of motivational interviewing intervention for risky drinking treatment ii Phase 2 the single-arm trial
Phase 1 translation and validation of questionnaires
Several questionnaires regarding the trial outcomes will need to be translated from English into Jakun the language of the indigenous tribe where the trial will take place
Questionnaires to be translated and validated are i Readiness to Change Questionnaire Revised Version RCQ ii Motivation Thought Frequency Scales for Alcohol MTF-A iii Brief Alcohol Abstinence Self-Efficacy 12-Item AASE Scale
The process of translation and backtranslation are performed by 2 medical experts and 2 language experts The selection of 2 medical experts is performed using purposive sampling medical professionals of Jakun origin with experience working in Rompin district Pahang Malaysia The selection of 2 language experts is performed using purposive sampling as well individuals of Jakun descent in Rompin district who are well-versed in both English and Jakun language but not knowledgeable about medical terminology
The harmonised version will undergo face validation among respondents who are selected randomly from RPS Kedaik the site for the questionnaire validation
Method to select participants for face validation From the spot map of the settlement numbers will be assigned to each house Simple random sampling will be performed using computer-generated random numbers A representative from the selected house will be invited to be a respondent
The resulting finalised version of RCQ-JK MTF-A-JK and AASE-JK will undergo a reliability and validation study From the spot map of the settlement numbers will be assigned to each house Simple random sampling will be performed using computer-generated random numbers A representative from the selected house will be screened ie age 18 years old who is a current drinker Those who fulfill these criteria will be invited to join the study
During informed consent process individual will be briefed using the simple Malay language with patient information sheet which is available in Jakun language as the guide to ensure understanding Individuals who cannot read can be represented by reliable kin or legally authorised representative
Phase 1 adaptation of motivational interviewing intervention for risky drinking treatment
This process will be guided by ADDIE Model analysis design development implementation and evaluation
In analysis phase a literature review will be conducted from which evidence are collected to inform the content development process eg published articles manuals guidelines
In design phase findings from the previous literature review will be discussed with a panel of experts using Nominal Group Technique There will be 4 experts selected using purposive sampling which include a public health medicine specialist a psychologist with certificate in motivational interviewing a researcher specialised in health promotion and a medical assistant in the local health clinic who is of Jakun descent The facilitator primary investigator will summarise the scores to ascertain the overall group priorities
In development phase the content derived from the previous 2 phases will be developed into a module for motivational interviewing intervention
At the end of content development content validity will be assessed by obtaining ratings from each member of the expert panel with regards to its relevance clarity simplicity and ambiguity Additionally there would also be content and face validation by another panel of expert
Implementation and evaluation phases will be conducted during the subsequent single-arm trial
Phase 2 single-arm trial
This trial will be conducted at another indigenous settlement located close to the one in previous phase called Kampung Jemeri
Sampling methods From the spot map of the settlement numbers will be assigned to each house Simple random sampling will be performed using computer-generated random numbers A representative from the selected house will be approached and explained about the study
During informed consent process individual will be briefed using simple Malay language with patient information sheet which is available in Bahasa Jakun as the guide to ensure understanding Individuals who cannot read can be represented by reliable kin or legally authorised representative If the individual agrees heshe will be screened using AUDIT-10 questionnaire Those with AUDIT-10 score between 8 and 19 will subjected to further eligibility criteria refer inclusion and exclusion criteria for Phase 2 Those who fulfill these criteria will be invited to join the study Those who do not fulfill these criteria will be thanked and will not be enrolled in the study
Measurement and data collection Participants information will be collected at 1st visit right after 1st intervention 6 weeks post-intervention and 3 months post-intervention
Why measurement is performed at immediately after 1st intervention 6 weeks and 3 months post-intervention A systematic review of reviews by Frost et al 2018 revealed consistent evidence on beneficial effect of motivational interview on alcohol consumption for short term outcomes less than 4 months but less consistent evidence on sustained more than 4 months outcomes Furthermore a systematic review and meta-analysis by Lundahl et al 2018 measuring the effect size of motivational interviewing indicated that between immediate and 1 month time frame after intervention MI impact shows odds ratio of 138 Between 5 weeks to 6 months odds ratio increases to 172 The odds ratio drops to 134 after 7 to 12 months of intervention aspect of the follow-up process
Strategies to increase participant retention include telephone contact to participants and In-person visits to participants homes Given that the follow-up will be conducted face-to-face reaching the participants at their residences is essentially crucial
Sample size calculation For face validation the sample size would be 10 Based on Sousa ampamp Rojjanasrirat 2011 who recommended a sample size of 10 to 40 for a pilot testing during the translation adaptation and validation of instruments for use in cross-cultural health care research
For assessment of reliability internal consistency - Cronbachs alpha and construct validity exploratory factor analysis EFA a sample size of 200 will be used
This recommendation is based on the work of Mokkink et al 2019 which suggests that for assessing internal consistency a minimum sample size of 100 is recommended For factor analysis the guideline is to have at least 7 times the number of items with a minimum sample size of 100 Given that each questionnaire has 12 items the ideal sample size would be 12 items 7 84 However since 100 is the minimum requirement the larger sample size of 100 should be used for both internal consistency and factor analysis
However to achieve more reliable results MacCallum et al 1999 suggested a larger sample between 100 and 200 in case of communalities around 05 Hence a sample size of 200 will be used
For further assessment of construct validity confirmatory factor analysis CFA a further sample size of 300 will be used This is based on Mokkink et al 2019 which proposes 7 times number of items for factor analysis with minimum 100 However to achieve more reliable results MacCallum et al 1999 suggested a larger sample of 300 in case of low communalities
For the Phase 2 single-arm trial the sample size calculation is performed using the equation from paired or matched groups for clinical studies Machin et al 2011
A study by Zatzick et alZatzick et al 2014 noted reduction of 18 95 CI 11 24 in AUDIT-10 score after 6 months following an MI intervention on 409 subjects
To calculate the standard deviation CI 196 x Standard error SE 18 - 11 196 x SE SE 0357 SE SD Sample size 0357 SD 409 Standard deviation SD 0357 x 409 722
Width of 95 CI ω 24 - 11 13 Anticipated standard deviation σPlan 722 ΛPlan ω σPlan 13 18 0722
Subsequently the sample size calculation is performed using the above equation yielding a sample size of 2948 which is rounded to 30
This is further confirmed by the table proposed by Machin et alMachin et al 2011 Where ΛPlan between 070 and 075 which gives m at 95 confidence interval between 55 and 63 When NPairs m2 the sample size would be between 275 and 315
Accounting for risk for lost to follow-up additional 20 will be recruited based on previous studies Gaume et al 2022 Jayaraj et al 2012 Therefore the minimum sample size would be 36
Exit strategy
Any participant who is found to have any of the following condition will require proper referral to the relevant medical personnel eg psychiatrist hospital i Serious mental illness previously undiagnosed ii Suspected to have alcohol dependence as evidence by AUDIT-10 score 20 iii Any serious adverse event such as one that is life-threatening or require hospitalisation iv Inability to continue participating in the study due to medical reason
Ethical consideration This study requires approval from the Faculty Ethics Review Committee Faculty of Medicine MARA University of Technology UiTM Malaysia and registration with National Medical Research Register NMRR Malaysia Permission from the Department of Indigenous People Development JAKOA is also required Data collection will only be initiated once the above approvals are obtained
Informed consent process will be conducted prior to inclusion using simple Malay language with patient information sheet which is available in Bahasa Jakun as the guide ensuring that individuals are provided with comprehensive information about the study Participants will be informed that their involvement is voluntary and they have the right to withdraw from the study at any time without repercussion
The counseling session will be conducted one-on-one in a designated area within the participants home to ensure privacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None