Resilient Students Training (ReST) : A Pilot RCT

NCT06157931 | Recruiting

• 1 other identifier: HSEARS20230815002_1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Resilience is the ability to survive and thrive despite significant adversity. Trials of resilience-promoting interventions for university students have shown significant improvements in students' resilience and reductions in depressive and stress symptoms. Therefore, the goal of this study is to examine the feasibility of Resilient Student Training Intervention (ReST) to enhance resilience and reduce symptoms of depression, anxiety, and stress in university students with at least one adverse childhood experience (ACE) in Hong Kong. The study will be conducted in two phases. Phase 1 is a co-designing approach with local university students to discover, define, develop, and deliver the ReST intervention based on the Double Diamond model (Design Council, 2015). In Phase 2, eligible participants will be randomly allocated to either receive the ReST intervention or a waitlist control group. In the intervention group, participants will receive one 60-minute individual session and two 90-minute group-based sessions. Our main objectives in this study are to answer the following research questions:

1. 1.Can an effective Resilience Student Training Intervention (ReST) be used to improve resilience among undergraduate students with adverse childhood experiences and mental distress?
2. 2.What proportion of eligible individuals participate, engage, and complete the interventions as part of the trial?
3. 3.What proportion of eligible individuals participate in, engage with, and complete research assessments, and what data quality and completion rates can therefore be obtained?
4. 4.Is the ReST intervention safe and acceptable from the participants' perspectives?
5. 5.What sample size is required for a definitive trial?

Conditions

Psychological Wellness

Keywords

Resilience; Mental Health; University Students; Resilient Student Training Intervention; Adverse Childhood Experiences; Depression; Anxiety; Stress

Outcome Measures

Primary Outcomes (4)

• Feasibility of the intervention

  Proportion of eligible individuals who consent, participate, and complete the intervention/ research assessments.

  Week 0 (baseline), Week 6 (post-intervention), and Week 10 (follow-up).

• Acceptability of the intervention

  Quantitative measure of participant satisfaction based on a 5-point Likert scale ranging from "1=Very Dissatisfied" to "5=Very Satisfied," and qualitative description of participants' perspectives on acceptability of the intervention.

  Week 6 (post-intervention) and Week 10 (follow-up).

• Safety of the intervention based on number of adverse events

  Number and type of adverse events will be recorded.

  Week 0 (baseline), Week 6 (post-intervention), and Week 10 (follow-up).

• Resilience

  The Brief Resilience Scale (BRS), a 6-item self-report questionnaire that measures perceived ability to bounce back from adversity will be used. Responses are provided on a 5-point Likert scale ranging from "strongly disagree=1" to "strongly agree=5." Scores are calculated based on the average of the 6 items, with cut-offs defined as low resilience (1-2.99), normal (3-4.30), and high (4.31-5.0). The Chinese BRS demonstrated good internal consistency, criterion validity, and construct validity when applied in university undergraduate students (Fung, 2020).

  Week 0 (baseline), Week 6 (post-intervention), and Week 10 (follow-up).

Secondary Outcomes (4)

• Depression

  Week 0 (baseline), Week 6 (post-intervention), and Week 10 (follow-up).

• Anxiety

  Week 0 (baseline), Week 6 (post-intervention), and Week 10 (follow-up).

• Stress

  Week 0 (baseline), Week 6 (post-intervention), and Week 10 (follow-up).

• Posttraumatic Stress

  Week 0 (baseline), Week 6 (post-intervention), and Week 10 (follow-up).

Other Outcomes (1)

• Experiences of the intervention/trial

  Week 6 (post-intervention), and Week 10 (follow-up).

Study Arms (2)

Resilient Student Training intervention (ReST)

EXPERIMENTAL

Each participant will receive 3 intervention sessions over a 6-week period (1 individual 60-minute session and two 90-minute group-based sessions) delivered by the same interventionist. The specific skills, intervention protocol and intervention manual will be developed in the Phase 1. The skills and exercises will aim to address pertinent areas of needs relating to self-concept, emotional awareness, and maintaining relationships. The individual session will be conducted based on self-assessment results, identifying presenting concerns and goal planning. Group sessions will be gamified to enhance engagement and reward progress. The first group session will build on the individual session's content in a group setting, with the aim to learn from peers. The second group session aims to reinforce the principles and skills learned in the individual session and group session 1 and plan for the future.

Behavioral: Resilient Student Training intervention (ReST)

Waitlist Control

NO INTERVENTION

The waitlist control group will not receive any additional support or interventions whilst waiting to receive the ReST intervention. These participants will be asked to report any psychological interventions or psychotropic medications that they have accessed outside of the trial whilst they are on the waiting list. Wait list control participants will be offered the ReST intervention following their 6-week follow-up assessment.

Interventions

Resilient Student Training intervention (ReST) BEHAVIORAL

ReST consists of one individual 60-minute session and two 90-minute group-based sessions.

Resilient Student Training intervention (ReST)

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Current PolyU undergraduate student;
• Low resilience (based on the BRS score between 1.00-2.99);
• Moderate to severe depression, anxiety, or stress (based on the DASS-21 cut-offs); and
• Self-report of at least one ACE (based on the WHO ACE-IQ).

You may not qualify if:

• Diagnosis of any mental illnesses;
• Developmental disability;
• Extremely severe levels of depression, anxiety, or stress (based on DASS-21 cut-offs); and
• Receiving any mental health or psychiatric service or resilience-promoting interventions currently or within the past 6 months.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing

Hong Kong, Hong Kong

RECRUITING

Related Publications (12)

• Ang WHD, Lau ST, Chen, LJ, Chew HSJ, Tan JH, Shorey S, Lau Y. Effectiveness of resilience interventions for higher education students: A meta-analysis and metaregression. J Educ Psychol. 2022 Oct;114(7):1670-94. doi: 10.1037/edu0000719

  BACKGROUND

• Design Council. The Double Diamond: A universally accepted depiction of the design process. Retrieved May 17, 2023 from https://www.designcouncil.org.uk/our-resources/the-double- diamond/

  BACKGROUND

• Dube SR, Anda RF, Felitti VJ, Chapman DP, Williamson DF, Giles WH. Childhood abuse, household dysfunction, and the risk of attempted suicide throughout the life span: findings from the Adverse Childhood Experiences Study. JAMA. 2001 Dec 26;286(24):3089-96. doi: 10.1001/jama.286.24.3089.

  PMID: 11754674 BACKGROUND

• Fung SF. Validity of the Brief Resilience Scale and Brief Resilient Coping Scale in a Chinese Sample. Int J Environ Res Public Health. 2020 Feb 16;17(4):1265. doi: 10.3390/ijerph17041265.

  PMID: 32079115 BACKGROUND

• Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.

  PMID: 18183564 BACKGROUND

• Ho GWK, Chan ACY, Chien WT, Bressington DT, Karatzias T. Examining patterns of adversity in Chinese young adults using the Adverse Childhood Experiences-International Questionnaire (ACE-IQ). Child Abuse Negl. 2019 Feb;88:179-188. doi: 10.1016/j.chiabu.2018.11.009. Epub 2018 Dec 2.

  PMID: 30513406 BACKGROUND

• Ho GWK, Chan ACY, Shevlin M, Karatzias T, Chan PS, Leung D. Childhood Adversity, Resilience, and Mental Health: A Sequential Mixed-Methods Study of Chinese Young Adults. J Interpers Violence. 2021 Oct;36(19-20):NP10345-NP10370. doi: 10.1177/0886260519876034. Epub 2019 Sep 15.

  PMID: 31524036 BACKGROUND

• Ho GWK, Karatzias T, Cloitre M, Chan ACY, Bressington D, Chien WT, Hyland P, Shevlin M. Translation and validation of the Chinese ICD-11 International Trauma Questionnaire (ITQ) for the Assessment of Posttraumatic Stress Disorder (PTSD) and Complex PTSD (CPTSD). Eur J Psychotraumatol. 2019 May 15;10(1):1608718. doi: 10.1080/20008198.2019.1608718. eCollection 2019.

  PMID: 31143410 BACKGROUND

• Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014 Mar 7;348:g1687. doi: 10.1136/bmj.g1687.

  PMID: 24609605 BACKGROUND

• Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.

  PMID: 18696313 BACKGROUND

• Oei TP, Sawang S, Goh YW, Mukhtar F. Using the Depression Anxiety Stress Scale 21 (DASS-21) across cultures. Int J Psychol. 2013;48(6):1018-29. doi: 10.1080/00207594.2012.755535. Epub 2013 Feb 21.

  PMID: 23425257 BACKGROUND

• Antony MM, Bieling PJ, Cox BJ, Enns MW, Swinson RP. Psychometric Properties of the 42-item and 21-item versions of the depression anxiety stress scales in clinical groups and a community sample. Psychol Assess. 1998;10(2): 176-81. doi:10.1037/1040-3590.10.2.176.

  BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavioral Symptoms; Mental Disorders

Study Officials

• Grace WK Ho, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin KH Kwok

CONTACT

(+852) 27665517; robin.kwok@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Open label parallel-group pilot RCT

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 6, 2023
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-09

Locations

HK (1)