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Trial registered on ANZCTR
Registration number
ACTRN12622000604707
Ethics application status
Approved
Date submitted
19/02/2022
Date registered
22/04/2022
Date last updated
23/03/2023
Date data sharing statement initially provided
22/04/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Adaptation of a resilience building intervention for young adults with adverse childhood experiences in Malaysia
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Scientific title
Evaluating the effect of a resilience building intervention for young adults with adverse childhood experience on psychological outcomes in Malaysia
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Secondary ID [1]
306485
0
Nil known
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Universal Trial Number (UTN)
Nil known
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Trial acronym
Nil known
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Linked study record
Nil known
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Health condition
Health condition(s) or problem(s) studied:
Adverse childhood experience
325346
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Condition category
Condition code
Mental Health
322728
322728
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Current studies will modify and implement a resilience-building intervention based on an R2 resilience program. The R2 Resilience program is designed with the principles of implementation science (Ryeroft-Malone et al.,2013). The multisystem aspect of the intervention allows it to focus on multiple systems for the individual’s change process and adaptation process around life circumstances. It emphasizes the surrounding environments to the individual. It is a curriculum-based approach grouping together all the well-researched factors (Ungar,2020). Then, the factors and aspects are modified and implemented into the resilience-building intervention accordingly.
It will focus on skills such as collaborative helping, making resources available, exploring barriers to change, building bridges to new services and support, identifying meaningful resources, keeping solutions complex, finding allies, asking whether coping strategies are adaptive or maladaptive, exploring the client's level of motivation of change and engage in advocacy.
The intervention will be carried out in Malay or English. It aims to encompass both languages and will be provided according to the native language of the participants. Therapists will be trained to follow the protocol and the manual. At the end of the session, a recap will be conducted. Dynamic assessment will be used to track the learning progress. Participants will use journaling as a method to practice the skills. In addition, progress and practice will be discussed at the beginning of each session. Only two formal assessments will be conducted throughout the studies: pre and post-measurement. The intervention will be conducted via physical session. The helper will be recruited to carry out the intervention and collect data. The current study will be designed with six sessions, each session 120 minutes. The sessions are 120 minutes per session and will be held weekly. The session will be conducted in a group of 5. Participants will be asked to journal their thought and process after the session. A discussion will be carried out at the beginning of every session to recap what has been learned. A session attendance checklist will be applied to monitor the session.
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Intervention code [1]
322907
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Treatment: Other
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Comparator / control treatment
Participants in the treatment group will undergo a resilience-building intervention for 120 minutes for 6 sessions, whereas participants from the control group will not receive any treatment.
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Control group
Active
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Outcomes
Primary outcome [1]
330532
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Adverse Childhood Experience Questionnaire - English & Malay Version
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Assessment method [1]
330532
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Timepoint [1]
330532
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Pre-measurement will be conducted at baseline, Post-measurement will be conducted three months after the 12th sessions
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Primary outcome [2]
330847
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Patient Health Questionnaire 9- English & Malay Version
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Assessment method [2]
330847
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Timepoint [2]
330847
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Pre-measurement will be conducted at baseline, Post-measurement will be conducted three months after the 12th sessions
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Primary outcome [3]
330848
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Brief Coping Orientation to Problem Experienced Scale - English & Malay Version
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Assessment method [3]
330848
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Timepoint [3]
330848
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Pre-measurement will be conducted at baseline, Post-measurement will be conducted three months after the 12th sessions
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Secondary outcome [1]
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Ryff's Scale of Psychological Well-being (SPWB) - English & Malay Version - This is a primary outcome
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Assessment method [1]
406535
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Timepoint [1]
406535
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Pre-measurement will be conducted at baseline, Post-measurement will be conducted three months after the 12th sessions
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Secondary outcome [2]
407804
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Quality of Life –WHOQL-BREF - English & Malay Version - This is a primary outcome
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Assessment method [2]
407804
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Timepoint [2]
407804
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Pre-measurement will be conducted at baseline, Post-measurement will be conducted three months after the 12th sessions
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Secondary outcome [3]
407805
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Subjective stress – Perceived Stress scale - English & Malay Version - This is a primary outcome
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Assessment method [3]
407805
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Timepoint [3]
407805
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Pre-measurement will be conducted at baseline, Post-measurement will be conducted three months after the 12th sessions
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Secondary outcome [4]
407806
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Personal Resources Questionnaire 2000 - English & Malay Version - This is a primary outcome
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Assessment method [4]
407806
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Timepoint [4]
407806
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Pre-measurement will be conducted at baseline, Post-measurement will be conducted three months after the 12th sessions
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Secondary outcome [5]
407807
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Adult Resilience Measure-Revised - English & Malay Version - This is a primary outcome
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Assessment method [5]
407807
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Timepoint [5]
407807
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Pre-measurement will be conducted at baseline, Post-measurement will be conducted three months after the 12th sessions
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Secondary outcome [6]
407808
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Biomarker - Measure changes in salivary cortisol - This is a primary outcome
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Assessment method [6]
407808
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Timepoint [6]
407808
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Pre-measurement will be conducted at baseline, Post-measurement will be conducted three months after the 12th sessions
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Secondary outcome [7]
407809
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Blood pressure (blood pressure measured with sphygmomanometer) - This is a primary outcome
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Assessment method [7]
407809
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Timepoint [7]
407809
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Pre-measurement will be conducted at baseline, Post-measurement will be conducted three months after the 12th sessions
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Eligibility
Key inclusion criteria
Participant inclusion criteria
1. Aged 18 to 30 years old
2. Scores more than four on the Adverse Childhood Experiences International Questionnaire
(ACE-IQ)
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Minimum age
18
Years
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Maximum age
30
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Individuals receiving psychological treatment or Intervention
2. Participants who demonstrate any severe psychopathology or psychiatric illness that requires
a psychopharmacological approach
3. Participants who received Intervention or therapy consistently in the past
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed. Central randomization by computer method is applied.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random Allocation Software (Saghaei., 2004)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
Nil
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Mixed Anova
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
12/09/2023
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Actual
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Date of last participant enrolment
Anticipated
28/09/2023
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Actual
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Date of last data collection
Anticipated
28/02/2024
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
24591
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Malaysia
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State/province [1]
24591
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Kuala Lumpur/Selangor
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Funding & Sponsors
Funding source category [1]
311078
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University
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Name [1]
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Universiti Kebangsaan Malaysia
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Address [1]
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Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
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Country [1]
311078
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Malaysia
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Primary sponsor type
Individual
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Name
Dr. Mahadir Ahmad
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Address
Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
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Country
Malaysia
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Secondary sponsor category [1]
312084
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None
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Name [1]
312084
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Nil
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Address [1]
312084
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Nil
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Country [1]
312084
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Other collaborator category [1]
282171
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Individual
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Name [1]
282171
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Dr. Mahadir Ahmad
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Address [1]
282171
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Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
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Country [1]
282171
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Malaysia
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Other collaborator category [2]
282172
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Individual
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Name [2]
282172
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Dr. Caryn Chan Mei Hsien
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Address [2]
282172
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Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
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Country [2]
282172
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Malaysia
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Other collaborator category [3]
282173
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Individual
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Name [3]
282173
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Assoc. Prof. Dr. Satirah Zainalabidin
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Address [3]
282173
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Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
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Country [3]
282173
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Malaysia
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Other collaborator category [4]
282174
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Individual
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Name [4]
282174
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Professor Dr. Michale Ungar
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Address [4]
282174
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School of Social Work
Dalhousie University
Suite 3242, Mona Campbell Building,
1459 LeMarchant Street
PO Box 15000 Halifax, Nova Scotia B3H 4R2
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Country [4]
282174
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Canada
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Other collaborator category [5]
282591
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Individual
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Name [5]
282591
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Dr Ponnusamy Subramaniam
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Address [5]
282591
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Centre for Healthy Ageing and Wellness,
Faculty of Health Sciences,
Universiti Kebangsaan Malaysia,
Jalan Raja Muda Abdul Aziz,
50300 Kuala Lumpur
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Country [5]
282591
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Malaysia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
310396
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Research Ethics Committee The national University of Malaysia
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Ethics committee address [1]
310396
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Tingkat 1, Blok Klinikal, Hospital Canselor Tuanku Muhriz, Pusat Perubatan UKM, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Kuala Lumpur.
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Ethics committee country [1]
310396
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Malaysia
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Date submitted for ethics approval [1]
310396
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27/09/2021
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Approval date [1]
310396
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24/01/2022
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Ethics approval number [1]
310396
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UKM PPI/111/8/JEP-2021-894
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Summary
Brief summary
As child abuse cases are reported throughout the world, their impact on a person's life is pervasive. Adverse childhood experience was first coined and introduced by Dr. Felitti in 1998; it was defined as a series of traumatic events such as abuses, neglect, and household dysfunction. Adverse childhood experiences are associated with obesity, cancer, difficulties with self-regulation, and emotion regulation. In addition, there are various implications on mental health as well as physical health. Hence, this study adapts and modifies a resilience fostering intervention among individuals with adverse childhood experiences in Malaysia. This intervention study will be designed based on Ungar’s model and modified accordingly to the Malaysian context by using a Biopsychosocial-ecological model. Seven steps framework will be used for the adaptation process. In addition, biomarker testing of stress via saliva will be administered to track and evaluate the effect of the intervention. The intervention will be conducted in both Malay and English languages. This will be a mixed design study. Focus group discussions and a randomized controlled trial intervention study will be included. A mixed-design ANOVA will be applied to compare the mean scores of the intervention group and control group. Study hypothesis H1: There are significantly increased scores for mental health and resilience between pretreatment and post-treatment of an individual with adverse childhood experiences who were in the intervention group and the control group H2: There are significantly lower scores of stresses and physical health between pre-treatment and post-treatment of an individual with adverse childhood experiences who were in the intervention group and the control group
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Trial website
Nil
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Trial related presentations / publications
Nil
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Public notes
Nil known
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Contacts
Principal investigator
Name
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Dr Dr. Mahadir Ahmad
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Address
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Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
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Country
117514
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Malaysia
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Phone
117514
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+60326878168
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Fax
117514
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Email
117514
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[email protected]
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Contact person for public queries
Name
117515
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Ng Jun Kiat
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Address
117515
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Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
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Country
117515
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Malaysia
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Phone
117515
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+60129722088
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Fax
117515
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Email
117515
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[email protected]
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Contact person for scientific queries
Name
117516
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Ng Jun Kiat
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Address
117516
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Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
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Country
117516
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Malaysia
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Phone
117516
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+60129722088
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Fax
117516
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Email
117516
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
To protect the privacy and confidentiality of clients' information.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
15504
Informed consent form
383614-(Uploaded-22-03-2022-18-20-31)-Study-related document.doc
15505
Ethical approval
383614-(Uploaded-14-03-2023-14-05-04)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF