Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-03-28 @ 10:34 PM
Study NCT ID:
NCT06583356
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-04
First Post:
2024-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motivational Interviewing Intervention For Risky Drinking Treatment Among Indigenous Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-01', 'studyFirstSubmitDate': '2024-09-01', 'studyFirstSubmitQcDate': '2024-09-01', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of alcohol consumption', 'timeFrame': '4 months', 'description': 'The extent of alcohol-related consequences e.g. social, legal, physical, and psychological problems (Babor et al., 2001). Measured by Alcohol Use Disorders Identification Test (AUDIT-10) score (validated Malay version - already available). Higher AUDIT-10 score indicates more severe alcohol consumption.'}], 'secondaryOutcomes': [{'measure': 'Readiness to change', 'timeFrame': '4 months', 'description': 'The extent to which an individual is cognitively and emotionally inclined to accept, embrace, and adopt a particular plan to purposefully alter the status quo (Holt et al., 2007). Measured by - Readiness to Change Questionnaire (Revised Version) (RCQ) (Jakun version - to be validated). Outcomes can be pre-contemplation, contemplation, or action stage.'}, {'measure': 'Motivation', 'timeFrame': '4 months', 'description': 'An internal state or condition that activates behaviour and gives it direction (Edelman, 1997). Measured by Motivation Thought Frequency Scales for Alcohol (MTF-A) (Jakun version - to be validated). Higher MTF-A score implies higher motivation to quit or cut down alcohol use.'}, {'measure': 'Self-efficacy', 'timeFrame': '4 months', 'description': "Individuals' beliefs or confidence in their capability to produce desired outcomes that affect their lives (Bandura \\& Wessels,1994). Measured by Brief Alcohol Abstinence Self-Efficacy 12-Item (AASE) Scale (Jakun version - to be validated). Higher AASE score indicates higher self-efficacy."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['motivational interviewing, risky drinking'], 'conditions': ['Alcohol Abuse']}, 'descriptionModule': {'briefSummary': '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.\n\nTo achieve this, the investigators will:\n\ni) Translate 3 questionnaires regarding alcohol consumption from English into Jakun language (a language of one of Malaysia\\&amp;amp;#39;s 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\n\nParticipants will:\n\ni) Answer translated questionnaires during the validation of questionnaires (phase 1) ii) Receive 3 sessions of motivational interviewing (phase 2)', 'detailedDescription': "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 2.6 million deaths annually as a result of the harmful alcohol use (WHO, 2024).\n\nRisky 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; O\\'Donnell et al., 2018).\n\nIndigenous 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 7.1% to as high as 34.8% (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).\n\nGlobally, 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 \\& 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).\n\nThere are several approaches in risky drinking intervention, namely pharmacological, psychological, and social support (d\\&amp;amp;#39;Abbs et al., 2013). Psychological intervention is found to be the most active and studied approach among indigenous populations (d\\'Abbs et al., 2013; Purcell-Khodr et al., 2020). This includes brief intervention, motivational interviewing, and cognitive behavioural therapy (Andersen et al., 2021; d\\'Abbs et al., 2013; Purcell-Khodr et al., 2020).\n\nMotivational interviewing is a counselling method to enhance motivation through resolution of ambivalence (Hall et al., 2012). It is a client-oriented counselling style (Miller \\& Rollnick, 2012), emphasising on a collaborative and non-confrontational approach (Hettema et al., 2005).\n\nPresently, 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.\n\nThe 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.\n\nThis study will be divided into 2 phases:\n\ni) 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\n\nPhase 1 (translation and validation of questionnaires)\n\nSeveral 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.\n\nQuestionnaires 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.\n\nThe 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.\n\nThe harmonised version will undergo face validation among respondents who are selected randomly from RPS Kedaik, the site for the questionnaire validation.\n\nMethod 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.\n\nThe 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 i.e. age ≥ 18 years old who is a current drinker. Those who fulfill these criteria will be invited to join the study.\n\nDuring 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.\n\nPhase 1 (adaptation of motivational interviewing intervention for risky drinking treatment)\n\nThis process will be guided by ADDIE Model (analysis, design, development, implementation, and evaluation).\n\nIn analysis phase, a literature review will be conducted from which evidence are collected to inform the content development process e.g. published articles, manuals, guidelines.\n\nIn 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.\n\nIn development phase, the content derived from the previous 2 phases will be developed into a module for motivational interviewing intervention.\n\nAt 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.\n\nImplementation and evaluation phases will be conducted during the subsequent single-arm trial.\n\nPhase 2 (single-arm trial)\n\nThis trial will be conducted at another indigenous settlement located close to the one in previous phase, called Kampung Jemeri.\n\nSampling 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.\n\nDuring 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, he/she 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.\n\nMeasurement and data collection Participants' information will be collected at 1st visit, right after 1st intervention, 6 weeks post-intervention, and 3 months post-intervention.\n\nWhy 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 1.38. Between 5 weeks to 6 months, odds ratio increases to 1.72. The odds ratio drops to 1.34 after 7 to 12 months of intervention aspect of the follow-up process.\n\nStrategies 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\n\nSample size calculation For face validation, the sample size would be 10. Based on Sousa \\&amp; 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.\n\nFor assessment of reliability (internal consistency - Cronbach's alpha) and construct validity (exploratory factor analysis (EFA)), a sample size of 200 will be used.\n\nThis 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.\n\nHowever, to achieve more reliable results, MacCallum et al. (1999) suggested a larger sample between 100 and 200 in case of communalities around 0.5. Hence a sample size of 200 will be used.\n\nFor 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.\n\nFor 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).\n\nA study by Zatzick et al.(Zatzick et al., 2014) noted reduction of 1.8 (95% CI 1.1, 2.4) in AUDIT-10 score after 6 months following an MI intervention on 409 subjects.\n\nTo calculate the standard deviation, CI = 1.96 x Standard error, SE 1.8 - 1.1 = 1.96 x SE SE = 0.357 SE = SD / (√Sample size) 0.357 = SD / (√409) Standard deviation, SD = 0.357 x √409 = 7.22\n\nWidth of 95% CI, ω = 2.4 - 1.1 = 1.3 Anticipated standard deviation, σPlan = 7.22 ΛPlan = ω / σPlan = 1.3 / 1.8 = 0.722\n\nSubsequently, the sample size calculation is performed using the above equation, yielding a sample size of 29.48, which is rounded to 30.\n\nThis is further confirmed by the table proposed by Machin et al.(Machin et al., 2011). Where ΛPlan between 0.70 and 0.75, which gives m at 95% confidence interval between 55 and 63. When NPairs = m/2, the sample size would be between 27.5 and 31.5.\n\nAccounting 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.\n\nExit strategy:\n\nAny participant who is found to have any of the following condition, will require proper referral to the relevant medical personnel e.g. 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\n\nEthical 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.\n\nInformed 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.\n\nThe counseling session will be conducted one-on-one in a designated area within the participant's home to ensure privacy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Phase 1 (validation of translated questionnaires)\n\nInclusion Criteria:\n\n* Individuals in the selected settlement age ≥ 18 years old who are current drinkers, irrespective of volume (current drinker is defined as individual who has consumed any alcoholic beverage in the past 12 months)\n* Agrees to participate in the study after explanation given\n\nExclusion Criteria:\n\n* Those with history of serious mental illness or cognitive impairment\n* Those who are unable to speak proficient Malay or Jakun language\n\nPhase 2 (single-arm trial):\n\nInclusion Criteria:\n\n* Individuals in the selected settlement and its surrounding, age ≥ 18 years old who are current drinkers\n* Agrees to participate in the study after explanation given\n\nExclusion Criteria:\n\n* AUDIT-10 score \\< 8 or \\> 19\n* Those with history of serious mental illness or cognitive impairment\n* Those who are currently on other alcohol intervention programmes\n* Those who are unable to speak proficient Malay or English language'}, 'identificationModule': {'nctId': 'NCT06583356', 'acronym': 'MIRDIP', 'briefTitle': 'Motivational Interviewing Intervention For Risky Drinking Treatment Among Indigenous Population', 'organization': {'class': 'OTHER', 'fullName': 'Department of Public Health Medicine, MARA University of Technology'}, 'officialTitle': 'The Adaptation and Effectiveness of Motivational Interviewing Intervention For Risky Drinking Treatment Among Indigenous Population: Protocol For A Single-arm Trial', 'orgStudyIdInfo': {'id': 'RSCH ID-24-01486-I7A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motivational interviewing', 'description': "Will receive motivational interviewing intervention previously, delivered face-to-face at participants' home, 1 session, followed by 2 brief follow-up sessions. Each session is expected to last approximately 30 to 45 minutes.", 'interventionNames': ['Behavioral: Motivational interviewing']}], 'interventions': [{'name': 'Motivational interviewing', 'type': 'BEHAVIORAL', 'description': "Participants will receive motivational interviewing intervention previously, delivered face-to-face at participants' home, 1 session, followed by 2 brief follow-up sessions. Each session is expected to last approximately 30 to 45 minutes.", 'armGroupLabels': ['Motivational interviewing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26800', 'city': 'Kuala Rompin', 'state': 'Pahang', 'country': 'Malaysia', 'contacts': [{'name': 'Rifhan Rasuli', 'role': 'CONTACT', 'email': 'drrifhan@moh.gov.my', 'phone': '+60145399301'}], 'facility': 'RPS Kedaik & Kampung Jemeri', 'geoPoint': {'lat': 2.81667, 'lon': 103.48333}}], 'centralContacts': [{'name': 'Rifhan Rasuli', 'role': 'CONTACT', 'email': 'drrifhan@moh.gov.my', 'phone': '+60145399301'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be securely retained for 7 years. Any disclosure of this information to a 3rd party will require explicit authorisation from MARA University of Technology, Malaysia.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Department of Public Health Medicine, MARA University of Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor of Public Health student', 'investigatorFullName': 'Rifhan Rasuli', 'investigatorAffiliation': 'Department of Public Health Medicine, MARA University of Technology'}}}}