Condition category
Not Applicable
Date applied
15/05/2020
Date assigned
23/05/2020
Last edited
21/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.letraalapitvany.hu/

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

Publication citations

Additional files

Editorial Notes

21/05/2020: Trial’s existence confirmed by Institutional Ethical Committee of the Eötvös Loránd University.