To examine the effectiveness of DaPI on parenting (i.e., parenting styles, parental self-efficacy and self-esteem, and parent mental health) and family relations (i.e., parent-adolescent and interparental conflicts, and family cohesion) in promoting children mental health via an 8-week randomised two-arm controlled trial.
Design
Two arm, community based, parallel group, single blind, randomised controlled trial
Settings and conduct
When parents submit their pre-intervention (baseline) assessment, they will be randomly assigned into the intervention or control group. Parents will find out their assignment: the intervention group will have immediate access, while those in the control group will have a 12 weeks’ delay to the program. Parents in the intervention and control groups will complete assessments at post-intervention (8 weeks later) and 1 month follow-up. Allocation is concealed from participants and care givers prior to assignment. The outcome assessor and data analyser will be blinded throughout the trial as they are not involved in the assignment of groups or the online program.
Participants/Inclusion and exclusion criteria
Inclusion:
a) Parents who owned a smart phone, tablet or computer and have access to the Internet.
c) Parents who are willing to participate and provide information at scheduled follow-up points.
d) Parents who have good command and understanding of the Malay language.
Exclusion:
a) Parents who are digital illiterate.
b) Parents who have children with developmental delays.
c) Parents who are currently receiving professional assistance for their own and/or their child’s mental health problems.
Intervention groups
Group (intervention) receives the online Digital-assisted Parenting Intervention (DaPI)
Group (control) Waitlisted and receives the DaPI after completion of the trial
Main outcome variables
Parenting, family relations and adolescents' mental health
General information
Reason for update
Acronym
DaPI (Digital-assisted Parenting Intervention)
IRCT registration information
IRCT registration number:IRCT20211129053207N1
Registration date:2022-01-29, 1400/11/09
Registration timing:prospective
Last update:2022-01-29, 1400/11/09
Update count:0
Registration date
2022-01-29, 1400/11/09
Registrant information
Name
Anis Raihan Dzeidee Schaff
Name of organization / entity
Universiti Putra Malaysia
Country
Malaysia
Phone
+60 3-9769 2541
Email address
gs61229@student.upm.edu.my
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-01, 1400/11/12
Expected recruitment end date
2022-05-01, 1401/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Establishing A Digital-Assisted Parenting Intervention (DaPI) in Promoting Children Mental Health
Public title
Establishing A Digital-Assisted Parenting Intervention (DaPI) in Promoting Children Mental Health
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Parents who owned a smart phone, tablet or computer and have access to the Internet.
Parents who are willing to participate and provide information at scheduled follow-up points.
Parents who have good command and understanding of the Malay language.
Exclusion criteria:
Parents who are digital illiterate.
Parents who have children with developmental delays.
Parents who are currently receiving professional assistance for their own and/or their child’s mental health problems.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
A project manager will be responsible to execute the randomization as to ensure blinding. Using simple random technique, each participant will be assigned with unique identification number generated by a random number generator using a 1:1 proportion. The participants will then be assigned to either the Digital-assisted Parenting Intervention (DaPI) or to the control group (i.e., waitlisted and will receive the intervention 12 weeks later).
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor and data analyser will be blinded because they are not involve with the allocation of groups or the online intervention. Data will be collected at pre-intervention (prior to group assignment), post-intervention (8-weeks) and 1 month follow up.
.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee for Research Involving Human Subjects Universiti Putra Malaysia (JKEUPM)
Street address
Jalan Universiti 1 Serdang, Seri Kembangan
City
Serdang
Postal code
43400
Approval date
2021-07-02, 1400/04/11
Ethics committee reference number
JKEUPM-2021-161
Health conditions studied
1
Description of health condition studied
Mental health
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Parenting styles
Timepoint
Before intervention, post-intervention (8 weeks), and 1 month follow-up
Method of measurement
Measured using the Parenting Scale by Arnold, O'Leary, Wolff, and Acker (1993)
2
Description
Parental self-efficacy
Timepoint
Before intervention, post-intervention (8 weeks), and 1 month follow-up
Method of measurement
Measured using the Child Adjustment and Parent Efficacy Scale by Morawska, Sanders, Haslam, Filus, & Fletcher (2014)
3
Description
Parent mental health
Timepoint
Before intervention, post-intervention (8 weeks), and 1 month follow-up
Method of measurement
Measured using the Depression Anxiety Stress Scales-21 (Lovibond & Lovibond, 1995)
4
Description
Parent-adolescent conflict
Timepoint
Before intervention, post-intervention (8 weeks), and 1 month follow-up
Method of measurement
Measured using the Network of Relationships Inventory (De Goede et al. 2009; Furman & Buhrmester 1985)
5
Description
Interparental conflict
Timepoint
Before intervention, post-intervention (8 weeks), and 1 month follow-up
Method of measurement
Measured using Parent Problem Checklist (PPC; Dadds & Powell, 1991)
6
Description
Family cohesion
Timepoint
Before intervention, post-intervention (8 weeks), and 1 month follow-up
Method of measurement
Measured using a scale developed by Tolan et al. (1997)
7
Description
Parental self-esteem
Timepoint
Before intervention, post-intervention (8 weeks), and 1 month follow-up
Method of measurement
Measured using the Rosenberg Self-esteem Scale
8
Description
Children Mental Health
Timepoint
Before intervention, post-intervention (8 weeks), and 1 month follow-up
Method of measurement
Measured using the Child Adjustment and Parent Efficacy Scale (CAPES; Morawska, Sanders, Haslam, Filus, & Fletcher, 2014)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Parents in the intervention group will be given immediate access to the DaPI program. Parents will be emailed log in details and instructions to the program. They will be prompted to complete the program within 8 weeks (at which time post-intervention assessment will be conducted regardless of the number of sessions completed). DaPI will be covered in 8 sessions. The content of the sessions includes fostering positive relationship with child ; fostering child's optimal growth ; fostering effective family functioning; fostering parent child relationships; fostering parents' mental health; and fostering child's mental health. Parents will be guided with effective parenting skills through various techniques (i.e., written materials, videos, interactive activities, and feedback report on parenting behaviors). Each session will be delivered once a week and take roughly around 30 to 40 minutes depending on the time parents spend on the tasks in each session. Parents can access the program at their own convenience. Parents will also be able to access links to evidence-based parenting support and informational resources provided in each session. Throughout the 8-week intervention period, parents will be contacted via email if no logged-on activity is detected to the program.
Category
Behavior
2
Description
Control group: Parents in the control (waitlist) group will receive no treatment during the trial but will be given access (12 weeks later) to the DaPI program once the trial ended.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Online via Social Media (i.e., Instagram and Facebook)
Full name of responsible person
Dr. Nor Sheereen Zulkefly
Street address
Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia
City
Serdang
Postal code
43400
Phone
+60 3-9769 2541
Email
sheereen@upm.edu.my
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Universiti Putra Malaysia
Full name of responsible person
Dr Nor Sheereen Zulkefly
Street address
Jalan Universiti 1 Serdang, Seri Kembangan
City
Serdang
Postal code
43400
Phone
+60 3-9769 2541
Email
sheereen@upm.edu.my
Web page address
https://www.upm.edu.my/
Grant name
Fundamental Research Grant Scheme (FRGS)
Grant code / Reference number
05-01-202275FR
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
High Education Ministry
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Universiti Putra Malaysia
Full name of responsible person
Dr Nor Sheereen Zulkefly
Position
Senior Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Jalan Universiti 1 Serdang, Seri Kembangan
City
Serdang
Province
Selangor
Postal code
43400
Phone
+60 3-9769 2541
Email
sheereen@upm.edu.my
Web page address
https://www.upm.edu.my/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Universiti Putra Malaysia
Full name of responsible person
Dr Nor Sheereen Zulkefly
Position
Senior Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Jalan Universiti 1 Serdang, Seri Kembangan
City
Serdang
Province
Selangor
Postal code
43400
Phone
+60 3-9769 2541
Email
sheereen@upm.edu.my
Web page address
https://www.upm.edu.my/
Person responsible for updating data
Contact
Name of organization / entity
Universiti Putra Malaysia
Full name of responsible person
Dr Nor Sheereen Zulkefly
Position
Senior Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Jalan Universiti 1 Serdang, Seri Kembangan
City
Serdang
Province
Selangor
Postal code
43400
Phone
+60 3-9769 2541
Email
sheereen@upm.edu.my
Web page address
https://www.upm.edu.my/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All collected deidentified IPD during the trial
When the data will become available and for how long
Beginning 3 months and ending 5 years after publication
To whom data/document is available
Only available for personnel working in academic institutions or related mental health services
Under which criteria data/document could be used
Any purpose. Proposal / request should be directed to Dr Nor Sheereen Zulkefly at sheereen@upm.edu.my. To gain access, requestor will need to sign a data access agreement
From where data/document is obtainable
Proposal / request should be directed to Dr Nor Sheereen Zulkefly at sheereen@upm.edu.my.
What processes are involved for a request to access data/document
Request should be made via email, directed to Dr Nor Sheereen Zulkefly, stating purpose of request and plans on how to use the data.