Plain English Summary
Background and study aims
In January 2020, the World Health Organization (WHO) declared the outbreak of a new coronavirus disease, COVID-19, to be a Public Health Emergency of International Concern (WHO, 2020). In that time of crisis which generates stress throughout the population, supporting mental and psychosocial well-being is warranted. Internet-based programs have been identified as an alternative means of intervention delivery during the pandemic.
The study aims to evaluate the engagement in, satisfaction with, and efficacy of an internet-based parent-training program for reducing parenting stress during the Covid-19 pandemic.
Who can participate?
Parents of at least one child below the age of 18 years old, with internet access, own mobile phone or computer.
What does the study involve?
Participants will be randomly allocated to either complete the online training program without having any contact with other participants or the clinician who follows their completion, or in addition to the program an online forum will be added to the structure of the training, where participants can share their experiences and contact each other, and ask the clinician, or in addition to this, the clinician will give personal feedback to assignments submitted by the participants.
What are the possible benefits and risks of participating?
Possible benefits of participating will be that participants will receive information about potential mental health challenges of the pandemic and effective coping strategies that help to avoid the adverse psychological effects of the pandemic in parents and children. They can practice these skills during the training. An additional benefit is that if one of the participants is identified as needing further professional help, the moderator will contact him or her and help him or her get the appropriate help/treatment.
Potential risks: Thinking about the pandemic and raising awareness of their own and their children’s stress reaction, worries and coping capacities may be anxiety provoking. In that case the participant can contact the moderator, and the moderator will help him or her get the appropriate help/treatment.
Where is the study run from?
1. Eötvös Loránd University (Hungary)
2. Heim Pál National Pediatric Institute (Hungary)
When is the study starting and how long is it expected to run for?
April 2020 to December 2020
Who is funding the study?
Eötvös Loránd University (Hungary)
Who is the main contact?
Dr Monika Miklósi, miklosi.monika@ppk.elte.hu
Trial website
Contact information
Type
Scientific
Primary contact
Dr Monika Miklósi
ORCID ID
https://orcid.org/0000-0001-8316-0410
Contact details
Eötvös Loránd University
Izbella 46
Budapest
1064
Hungary
+36 20 3948183
miklosi.monika@ppk.elte.hu
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
2020/185
Study information
Scientific title
Online parent training for reducing parenting stress during the COVID-19 pandemic: a randomized controlled trial
Acronym
Study hypothesis
The online training program will result in a significant reduction in parents’ level of stress and a significant increase in well-being and parental self-efficacy
Ethics approval
Approved 12/05/2020, Faculty of Education and Psychology, Research Ethics Committee of the Eötvös Loránd University (Izbella 46, Budapest 1064, Hungary; + (36-1) 461-2600 / 5614; molnar.mark@ppk.elte.hu), ref: 2020/185
Study design
Interventional randomized controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Internet
Trial type
Prevention
Patient information sheet
In Hungarian: https://drive.google.com/open?id=12NHiQh8iFOInp_8fnQnfNA3lLk-2yNem
Condition
Parental stress during COVID-19 pandemic
Intervention
The study aims to examine the effect of an online parent training in reducing parental stress during Covid-19 pandemic and to determine the optimal design of the program by means of engagement in, satisfaction with, and efficacy of the program.
The training program consists of two modules, one focusing on parents’ stress, and the second focusing on children’s stress and parenting practices that are appropriate during the pandemic time. Each module consists of 5 topics with short psychoeducative videos and written materials, while quizzes, worksheets, and feedback forms are included for increasing engagement. Parents can flexibly go through the topics during two weeks, requiring a 15-30-minutes daily online activity.
To explore the optimal structure of the training, participants will be randomized into three conditions.
In group 1., parents complete the online training program without having any contact with other participants or the clinician who follows their completion. The clinician contacts a parent only in case of emergency.
In group 2., an online forum will be added to the structure of the training, where participants can share their experiences and contact each other, and ask the clinician. The clinician will be involved in the forum and answer the questions.
In group 3., in addition to this, the clinician will give personal feedback to assignments submitted by the participants.
Block randomization with randomly selected block sizes of 6, 12 is used. The randomization scheme is generated by using the Web site Randomization.com (http://www.randomization.com
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
In the parent, according to self-report, measured in four time-points: at baseline, post-treatment, 1- and 3-months follow-up:
1. Perceived stress (Perceived Stress Scale, four-item version, PSS4)
2. Psychological well-being (WHO Well-being Index, WBI)
3. Parenting stress (Parental Stress Scale, shortened)
4. Parental competence (Parental Sense of Competence Scale, PSOC)
Secondary outcome measures
According to self-report, measured in four time-points: at baseline, post-treatment, 1- and 3-months follow-up:
1. Parenting behaviour (Multidimensional Assessment of Parenting Behavior, MAPS)
2. Children’s quality of life (Inventar zur Erfassung der Lebensqualitaet für Kindern und Jugendlichen, ILK)
Overall trial start date
06/04/2020
Overall trial end date
15/12/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Being a parent of at least one child below the age of 18 years old
2. Internet access, own mobile phone or computer
Though both parents can take part in the training, only data from one parent per family will be included in analyses
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
18/05/2020
Recruitment end date
30/11/2020
Locations
Countries of recruitment
Hungary
Trial participating centre
Eötvös Loránd University
Psychological Institute
Izabella 46
Budapest
1064
Hungary
Trial participating centre
Heim Pál National Pediatric Institute
Faludi 5
Budapest
1138
Hungary
Sponsor information
Organisation
Heim Pál National Pediatric Institute LÉTRA Foundation
Sponsor details
Garas 9
Budapest
1026
Hungary
+36 1 349-1514
mentalamb@heimpalkorhaz.hu
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Eötvös Loránd University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.
Intention to publish date
15/01/2021
Participant level data
Other
Basic results (scientific)
Publication list