Feasibility, Acceptability, and Effectiveness of a Coping and Resilience Intervention in Adolescents in the Post-COVID-19 Era
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Taipei Medical University
- Enrollment
- 110
- Locations
- 2
- Primary Endpoint
- Feasibility Measure: Time required to recruit to target participants
Study Overview
Brief Summary
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:
- Is CERIA feasible for adolescents in the post-COVID-19 era?
- Is CERIA acceptable for adolescents in the post-COVID-19 era?
- What is the effect of CERIA on PTSD symptoms, defensive coping, courageous coping, social support, resilience, and HRQOL in adolescents in the experimental group compared to those in the control group in the post-COVID-19 era?
- Are there any differences in the mean scores of PTSD symptoms, defensive coping, courageous coping, social support, resilience, and HRQOL between the experimental and control groups at:
- one week before,
- one week after, and
- one month after CERIA?
Participants in the experimental group will be given six-weekly 45-60 minutes CERIA sessions, whereas participants in the control groups will be treated as active control. Researchers will compare the experimental and control groups to see the effect of the intervention (CERIA) to decrease the adolescents' PTSD symptoms and defensive coping and increase courageous coping, social support, resilience, and HRQOL at three different time points: one week before intervention, one week after intervention, and one month after the intervention.
Detailed Description
Content Validity for the Intervention (An Expert Panel)
The content validity for the CERIA is aimed to validate the appropriateness of CERIA by an expert panel. Panel members will be selected based on their educational expertise and experiences related to the study. The experts who will be invited to participate in the panel have to meet the following criteria: 1) have more than five years of clinical or research experience in psychoeducation, adolescents, and/or related field, 2) be willing to participate in the content validity study, and 3) be able to effectively communicate in either English or Indonesian language. Since this study will be conducted in the school setting, panel members can include university/ faculty members who have experience with the study topic, school counselors (teachers who are responsible for counseling programs in the school), assistant principal of student affairs (dean of students), and/or assistant principal of academic affairs and curriculum. School nurses will also be invited if any and if possible.
The sample size of a content validity study is related to a satisfactory content validation index (CVI) that is applied to assess the content validity of each item of the intervention protocol. In this study, the CVI will be adopted to identify the required sample size and level of consensus of the expert panel. As recommended, six experts are needed to reach a satisfactory CVI of 0.83 for each item on the content validity assessment form.
Content Validity Study Procedure
A formal invitation will be delivered via telephone or email to solicit eligible experts to participate in the study. Once the experts accept the invitation, a cover letter, and the content validity assessment form will be mailed to them. The cover letter consists of the purpose of the study, the selection criteria of the expert panel, detailed information on the assessment form (the CERIA intervention protocol), and instructions for rating each item. The assessment form includes several items associated with the CERIA intervention protocol, including the intervention content (rationale of the topic, intervention approach, therapeutic principle or components of the intervention activities per session), intervention design (duration of each session, number of intervention session in total, frequency of each session, length of intervention, setting, interventionist criteria, group participants), and components of the intervention manual (a guide book for educators and another guide book for participants). The rating of each item is based on a 4-point Likert scale (4= very appropriate, 3= appropriate, 2= inappropriate, and 1= very inappropriate). If the experts scored any of the items below a score of 3, they will be asked to provide comments or suggestions with relevant evidence and references to help the study further refine the intervention protocol.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •being aged 12-18 years old
- •being enrolled in the participating public junior high schools in Yogyakarta
- •voluntarily agreeing to participate by completing both the student-assent and parent-informed consent forms
Exclusion Criteria
- •individuals with mental retardation, psychosis, or any neurological disorders
Outcomes
Primary Outcomes
Feasibility Measure: Time required to recruit to target participants
Time Frame: 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.
Assessment on the length of participants recruitment.
Feasibility Measure: Participant recruitment rate
Time Frame: From the date of the participant recruitment, assessed up to 1 week.
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.
Feasibility Measure: Participant attrition rate
Time Frame: From the date of the participant recruitment until the date of follow-up measurement, assessed up to 14 weeks.
Assessment on the loss of study participants over time.
Feasibility Measure: Participant compliance and completeness of evaluation measures at pre-test
Time Frame: On the date of the pre-test, assessed up to 1 day.
Assessment on the participant compliance and completeness of the evaluation measures (pre-test) using a checklist.
Feasibility Measure: Participant compliance and completeness of evaluation measures at post-test
Time Frame: On the date of the post-test, assessed up to 1 day.
Assessment on the participant compliance and completeness of the evaluation measures (post-test) using a checklist.
Acceptability Measure: Participants' perspective on the intervention
Time Frame: On the date of the last session of CERIA, assessed up to 1 day.
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).
Feasibility Measure: Participant retention rate
Time Frame: From the date of the participant recruitment until the date of follow-up measurement, assessed up to 14 weeks.
Assessment on the the method and techniques used to prevent participants in the study from withdrawing or dropping out.
Feasibility Measure: Participant compliance with intervention
Time Frame: assessed up to 6 weeks
Assessment on the participant compliance with CERIA sessions using an attendance list.
Feasibility Measure: Participant compliance and completeness of evaluation measures at follow-up
Time Frame: On the date of the follow-up, assessed up to 1 day.
Assessment on the participant compliance and completeness of the evaluation measures (follow-up) using a checklist.
Acceptability Measure: An exit survey (participants' perspective on the intervention)
Time Frame: On the following day after the last session of CERIA, assessed up to 1 week.
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).
Acceptability Measure: Interventionist's perspective on the intervention
Time Frame: On the date of each sessions (session 1 to 6) of CERIA, assessed up to 6 weeks.
An 8-item question that measures interventionist's perspective on the CERIA.
Acceptability Measure: Content validity for the intervention (an expert panel)
Time Frame: Assessed up to 8 weeks.
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.
Secondary Outcomes
- 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)
- 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)
Investigators
Okki Dhona Laksmita
Principal Investigator
Taipei Medical University