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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
Scientific title
Evaluating the effect of a resilience building intervention for young adults with adverse childhood experience on psychological outcomes in Malaysia
Secondary ID [1] 306485 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
Nil known
Linked study record
Nil known

Health condition
Health condition(s) or problem(s) studied:
Adverse childhood experience 325346 0
Condition category
Condition code
Mental Health 322728 322728 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 322907 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 330532 0
Adverse Childhood Experience Questionnaire - English & Malay Version

Timepoint [1] 330532 0
Pre-measurement will be conducted at baseline, Post-measurement will be conducted three months after the 12th sessions
Primary outcome [2] 330847 0
Patient Health Questionnaire 9- English & Malay Version
Timepoint [2] 330847 0
Pre-measurement will be conducted at baseline, Post-measurement will be conducted three months after the 12th sessions
Primary outcome [3] 330848 0
Brief Coping Orientation to Problem Experienced Scale - English & Malay Version
Timepoint [3] 330848 0
Pre-measurement will be conducted at baseline, Post-measurement will be conducted three months after the 12th sessions
Secondary outcome [1] 406535 0
Ryff's Scale of Psychological Well-being (SPWB) - English & Malay Version - This is a primary outcome
Timepoint [1] 406535 0
Pre-measurement will be conducted at baseline, Post-measurement will be conducted three months after the 12th sessions
Secondary outcome [2] 407804 0
Quality of Life –WHOQL-BREF - English & Malay Version - This is a primary outcome
Timepoint [2] 407804 0
Pre-measurement will be conducted at baseline, Post-measurement will be conducted three months after the 12th sessions
Secondary outcome [3] 407805 0
Subjective stress – Perceived Stress scale - English & Malay Version - This is a primary outcome
Timepoint [3] 407805 0
Pre-measurement will be conducted at baseline, Post-measurement will be conducted three months after the 12th sessions
Secondary outcome [4] 407806 0
Personal Resources Questionnaire 2000 - English & Malay Version - This is a primary outcome
Timepoint [4] 407806 0
Pre-measurement will be conducted at baseline, Post-measurement will be conducted three months after the 12th sessions
Secondary outcome [5] 407807 0
Adult Resilience Measure-Revised - English & Malay Version - This is a primary outcome
Timepoint [5] 407807 0
Pre-measurement will be conducted at baseline, Post-measurement will be conducted three months after the 12th sessions
Secondary outcome [6] 407808 0
Biomarker - Measure changes in salivary cortisol - This is a primary outcome
Timepoint [6] 407808 0
Pre-measurement will be conducted at baseline, Post-measurement will be conducted three months after the 12th sessions
Secondary outcome [7] 407809 0
Blood pressure (blood pressure measured with sphygmomanometer) - This is a primary outcome
Timepoint [7] 407809 0
Pre-measurement will be conducted at baseline, Post-measurement will be conducted three months after the 12th sessions

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)
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is concealed. Central randomization by computer method is applied.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random Allocation Software (Saghaei., 2004)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed Anova

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/09/2023
Actual
Date of last participant enrolment
Anticipated
28/09/2023
Actual
Date of last data collection
Anticipated
28/02/2024
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 24591 0
Malaysia
State/province [1] 24591 0
Kuala Lumpur/Selangor

Funding & Sponsors
Funding source category [1] 311078 0
University
Name [1] 311078 0
Universiti Kebangsaan Malaysia
Country [1] 311078 0
Malaysia
Primary sponsor type
Individual
Name
Dr. Mahadir Ahmad
Address
Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 312084 0
None
Name [1] 312084 0
Nil
Address [1] 312084 0
Nil
Country [1] 312084 0
Other collaborator category [1] 282171 0
Individual
Name [1] 282171 0
Dr. Mahadir Ahmad
Address [1] 282171 0
Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country [1] 282171 0
Malaysia
Other collaborator category [2] 282172 0
Individual
Name [2] 282172 0
Dr. Caryn Chan Mei Hsien
Address [2] 282172 0
Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country [2] 282172 0
Malaysia
Other collaborator category [3] 282173 0
Individual
Name [3] 282173 0
Assoc. Prof. Dr. Satirah Zainalabidin
Address [3] 282173 0
Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country [3] 282173 0
Malaysia
Other collaborator category [4] 282174 0
Individual
Name [4] 282174 0
Professor Dr. Michale Ungar
Address [4] 282174 0
School of Social Work
Dalhousie University
Suite 3242, Mona Campbell Building,
1459 LeMarchant Street
PO Box 15000 Halifax, Nova Scotia B3H 4R2
Country [4] 282174 0
Canada
Other collaborator category [5] 282591 0
Individual
Name [5] 282591 0
Dr Ponnusamy Subramaniam
Address [5] 282591 0
Centre for Healthy Ageing and Wellness,

Faculty of Health Sciences,
Universiti Kebangsaan Malaysia,
Jalan Raja Muda Abdul Aziz,
50300 Kuala Lumpur
Country [5] 282591 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310396 0
Research Ethics Committee The national University of Malaysia
Ethics committee address [1] 310396 0
Tingkat 1, Blok Klinikal, Hospital Canselor Tuanku Muhriz, Pusat Perubatan UKM, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Kuala Lumpur.
Ethics committee country [1] 310396 0
Malaysia
Date submitted for ethics approval [1] 310396 0
27/09/2021
Approval date [1] 310396 0
24/01/2022
Ethics approval number [1] 310396 0
UKM PPI/111/8/JEP-2021-894

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
Trial website
Nil
Trial related presentations / publications
Nil
Public notes
Nil known

Contacts
Principal investigator
Name 117514 0
Dr Dr. Mahadir Ahmad
Address 117514 0
Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country 117514 0
Malaysia
Phone 117514 0
+60326878168
Fax 117514 0
Email 117514 0
mahadir@ukm.edu.my
Contact person for public queries
Name 117515 0
Mr Ng Jun Kiat
Address 117515 0
Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country 117515 0
Malaysia
Phone 117515 0
+60129722088
Fax 117515 0
Email 117515 0
p108756@siswa.ukm.edu.my
Contact person for scientific queries
Name 117516 0
Mr Ng Jun Kiat
Address 117516 0
Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country 117516 0
Malaysia
Phone 117516 0
+60129722088
Fax 117516 0
Email 117516 0
p108756@siswa.ukm.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To protect the privacy and confidentiality of clients' information.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15504Informed consent form    383614-(Uploaded-22-03-2022-18-20-31)-Study-related document.doc
15505Ethical 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.