NCT06583356

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 Malaysia\'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 Participants will: i) Answer translated questionnaires during the validation of questionnaires (phase 1) ii) Receive 3 sessions of motivational interviewing (phase 2)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2024

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

September 4, 2024

Status Verified

September 1, 2024

Enrollment Period

7 months

First QC Date

September 1, 2024

Last Update Submit

September 1, 2024

Conditions

Keywords

motivational interviewing, risky drinking

Outcome Measures

Primary Outcomes (1)

  • Severity of alcohol consumption

    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.

    4 months

Secondary Outcomes (3)

  • Readiness to change

    4 months

  • Motivation

    4 months

  • Self-efficacy

    4 months

Study Arms (1)

Motivational interviewing

EXPERIMENTAL

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.

Behavioral: Motivational interviewing

Interventions

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.

Motivational interviewing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • Agrees to participate in the study after explanation given

You may not qualify if:

  • Those with history of serious mental illness or cognitive impairment
  • Those who are unable to speak proficient Malay or Jakun language
  • Phase 2 (single-arm trial):
  • Individuals in the selected settlement and its surrounding, age ≥ 18 years old who are current drinkers
  • Agrees to participate in the study after explanation given
  • AUDIT-10 score \< 8 or \> 19
  • Those with history of serious mental illness or cognitive impairment
  • Those who are currently on other alcohol intervention programmes
  • Those who are unable to speak proficient Malay or English language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RPS Kedaik & Kampung Jemeri

Kuala Rompin, Pahang, 26800, Malaysia

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Public Health student

Study Record Dates

First Submitted

September 1, 2024

First Posted

September 4, 2024

Study Start

October 1, 2024

Primary Completion

April 30, 2025

Study Completion

May 31, 2025

Last Updated

September 4, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

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.

Locations