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CERIA
Feasibility, Acceptability, and Effectiveness of a Coping and Resilience Intervention in Adolescents in the Post-COVID-19 Era
Sponsor study identifier
interventional
110
1 country
1
Study Start
July 10, 2023
Actual (reported)Primary Completion
October 31, 2023
Actual (reported)Study Completion
October 31, 2023
Actual (reported)The primary purpose of this study is to assess the feasibility and acceptability of a coping and resilience intervention for adolescents in school settings named CERIA, in the post-coronavirus disease 2019 or COVID-19 era. Whereas the secondary purpose of this study is to assess the effect of the intervention among adolescents on several outcomes, including posttraumatic stress disorder (PTSD) symptoms, defensive coping, courageous coping, social support, resilience, and health-related quality of life (HRQOL), in the post-COVID-19 era, at baseline or pre-test (one week before), right after/immediate effect or post-test (one week after), and one-month follow-up or short-term effect (one month after intervention). The research questions in this study include the following:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 21, 2022
Actual (reported)April 26, 2023
Actual (reported)July 10, 2023
Actual (reported)October 31, 2023
Actual (reported)October 31, 2023
Actual (reported)Feasibility Measure: Time required to recruit to target participants
Assessment on the length of participants recruitment.
From date of parent informed consent and student assent forms distribution until the date of consents qualification by the investigators, assessed up to 1 week.
Feasibility Measure: Participant recruitment rate
Assessment on the process when potential participants are given information about the study to gauge their interest in and desire to participate as research subjects prior to being enrolled.
From the date of the participant recruitment, assessed up to 1 week.
Feasibility Measure: Participant retention rate
Assessment on the the method and techniques used to prevent participants in the study from withdrawing or dropping out.
From the date of the participant recruitment until the date of follow-up measurement, assessed up to 14 weeks.
Children's Revised Revised Impact of Event Scale (CRIES-13)
One week before intervention, one week after intervention, and one-month after intervention
Jalowiec Coping Scale (JCS)
One week before intervention, one week after intervention, and one-month after intervention
Multidimensional Scale of Perceived Social Support (MSPSS)
One week before intervention, one week after intervention, and one-month after intervention
Child and Youth Resilience Measure 28 (CYRM-28)
One week before intervention, one week after intervention, and one-month after intervention
Pediatric Quality of Life Inventory (PedsQLTM) 4.0 Generic Core youth version and parent proxy
One week before intervention, one week after intervention, and one-month after intervention
Participants in the experimental group will receive six-weekly 45-60 minutes CERIA sessions in a classroom setting.
Printing materials for the CERIA sessions will be given to school counselors who provide school counseling programs in the control group. There will be no face-to-face meeting between the participants in the control group and the interventionist.
It is a school-based resilience enhancement program to help adolescents build skills of positive coping and social support to minimize negative coping and distress by sharing, identifying, and discussing their feelings, thoughts, and actions regarding problems and stressful events.
Okki Dhona Laksmita
Yogyakarta, 55121, Indonesia
Allen, S. F., Pfefferbaum, B., Nitiéma, P., Pfefferbaum, R. L., Houston, J. B., McCarter, G. S., & Gray, S. R. (2016). Resilience and coping intervention with children and adolescents in at-risk neighborhoods. Journal of Loss and Trauma, 21(2), 85-98. doi:https://doi.org/10.1080/15325024.2015.1072014
Beames JR, Li SH, Newby JM, Maston K, Christensen H, Werner-Seidler A. The upside: coping and psychological resilience in Australian adolescents during the COVID-19 pandemic. Child Adolesc Psychiatry Ment Health. 2021 Dec 18;15(1):77. doi: 10.1186/s13034-021-00432-z.
Bonardi O, Wang Y, Li K, Jiang X, Krishnan A, He C, Sun Y, Wu Y, Boruff JT, Markham S, Rice DB, Thombs-Vite I, Tasleem A, Santo TD, Yao A, Azar M, Agic B, Fahim C, Martin MS, Sockalingam S, Turecki G, Benedetti A, Thombs BD. Effects of COVID-19 Mental Health Interventions Among Children, Adolescents, and Adults Not Quarantined or Undergoing Treatment Due to COVID-19 Infection: A Systematic Review of Randomised Controlled Trials. Can J Psychiatry. 2022 May;67(5):336-350. doi: 10.1177/07067437211070648. Epub 2022 Mar 11.
Okki D Laksmita, MSc
School of Nursing, College of Nursing, Taipei Medical University
110 participants (actual enrollment reported by the registry).
First Submitted
December 21, 2022
First Posted
April 26, 2023
Study Start
July 10, 2023
Actual (reported)Feasibility Measure: Participant attrition rate
Assessment on the loss of study participants over time.
From the date of the participant recruitment until the date of follow-up measurement, assessed up to 14 weeks.
Feasibility Measure: Participant compliance with intervention
Assessment on the participant compliance with CERIA sessions using an attendance list.
assessed up to 6 weeks
Feasibility Measure: Participant compliance and completeness of evaluation measures at pre-test
Assessment on the participant compliance and completeness of the evaluation measures (pre-test) using a checklist.
On the date of the pre-test, assessed up to 1 day.
Feasibility Measure: Participant compliance and completeness of evaluation measures at post-test
Assessment on the participant compliance and completeness of the evaluation measures (post-test) using a checklist.
On the date of the post-test, assessed up to 1 day.
Feasibility Measure: Participant compliance and completeness of evaluation measures at follow-up
Assessment on the participant compliance and completeness of the evaluation measures (follow-up) using a checklist.
On the date of the follow-up, assessed up to 1 day.
Acceptability Measure: Participants' perspective on the intervention
A 17-item questionnaire that measure participants' perspective on the intervention and a focused-group discussion (FGD) under the theoretical framework of acceptability (TFA) to assess prospective (i.e. experienced) and retrospective (i.e. experienced) acceptability from the participants. There will be 12 open-ended questions developed by researchers to guide the FGD. The FGD will only be conducted in one of the group of participants (10 students).
On the date of the last session of CERIA, assessed up to 1 day.
Acceptability Measure: An exit survey (participants' perspective on the intervention)
A 17-item questionnaire and the 12 open-ended questions about discontinuation of the study (only for students who discontinue to participate in the study, but at least attend 1 session of CERIA).
On the following day after the last session of CERIA, assessed up to 1 week.
Acceptability Measure: Interventionist's perspective on the intervention
An 8-item question that measures interventionist's perspective on the CERIA.
On the date of each sessions (session 1 to 6) of CERIA, assessed up to 6 weeks.
Acceptability Measure: Content validity for the intervention (an expert panel)
An expert panel (6-8 experts) to evaluate the validity of the CERIA based on intervention appropriateness (intervention's content, design, components for each sessions, and evaluation). Each component has a four Likert-type option from 4= very appropriate, 3= appropriate, 2= inappropriate, and 1= very inappropriate. Experts who have any questions/comments/suggestions about CERIA can write them down on a rating form.
Assessed up to 8 weeks.
Printing materials for the CERIA sessions will be given to school counselors who provide school counseling programs in the control group.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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Primary Completion
October 31, 2023
Actual (reported)Study Completion
October 31, 2023
Actual (reported)Last Updated
March 21, 2024
Record last verified: 2024-03
Particular data will be shared: Individual participant data that underlie the results reported in this article, after identification (text, tables, figures, and appendices).
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