A Coping and Resilience Intervention in Adolescents

NCT05830188 | Completed

• 1 other identifier: ceria2022
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pandemic

Keywords

coping; COVID-19; health-related quality of life; PTSD symptoms; resilience; school-based intervention; social support

Outcome Measures

Primary Outcomes (12)

• 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.

• 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.

Secondary Outcomes (5)

• 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

Study Arms (2)

CERIA

EXPERIMENTAL

Participants in the experimental group will receive six-weekly 45-60 minutes CERIA sessions in a classroom setting.

Behavioral: Coping and Resilience Intervention for Adolescents

Control

ACTIVE COMPARATOR

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.

Other: Printing materials of Coping and Resilience Intervention for Adolescents

Interventions

Coping and Resilience Intervention for Adolescents BEHAVIORAL

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.

Also known as: CERIA

CERIA

Printing materials of Coping and Resilience Intervention for Adolescents OTHER

Printing materials for the CERIA sessions will be given to school counselors who provide school counseling programs in the control group.

Also known as: Printing materials of CERIA

Control

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• individuals with mental retardation, psychosis, or any neurological disorders

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Okki Dhona Laksmita

Yogyakarta, 55121, Indonesia

Location

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MeSH Terms

Conditions

COVID-19

Interventions

Coping Skills

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Okki D Laksmita, MSc

  School of Nursing, College of Nursing, Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: April 26, 2023
• Study Start: July 10, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. For example, for meta-analysis study.

Locations

ID (1)