Efficacy of Mountain Craft Training at Enhancing the Resilience and Physio-psychological Well-being of Children From Low-income Families

February 27, 2024 updated by: Dr Joyce Chung, The Hong Kong Polytechnic University

Efficacy of Mountain Craft Training at Enhancing the Resilience and Physical and Psychological Well-being of Children From Low-income Families: A Pilot Randomised Controlled Trial

It is imperative to offer adequate community resources and psychosocial support, with a particular focus on enhancing resilience for children from low-income families. This study aims to determine the feasibility, acceptability, and preliminary efficacy of mountain craft training in enhancing resilience and self-esteem, reducing depressive symptoms, and improving the physical health of children from low-income families.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

It is imperative to offer adequate community resources and psychosocial support, with a particular focus on enhancing resilience for children from low-income families. This study aims to determine the feasibility, acceptability, and preliminary efficacy of mountain craft training in enhancing resilience and self-esteem, reducing depressive symptoms, and improving the physical health of children from low-income families. This will be a pilot RCT using a two-group pre- and post-test within-subject design. The investigators plan to recruit 40 children in the Kwai Tsing District to participate in this study via the Asbury Methodist Social Service. Participants in the intervention group will be invited to join the mountain craft training programme. The research team will work with Mountain & Stream (https://www.mtandstream.com/) to offer a tailor-made hiking training programme for Form 1 students. Participants will be invited to join a control intervention that mimics the time and attention received by participants in the intervention group but will be designed to have no specific effect on the outcome variables. The investigators hypothesise that participants who receive mountain craft training (six sessions) over 3 months will report significant improvements in: (i) resilience, (ii) self-esteem; (iii) depressive symptoms, and (iv) physical well-being compared with those in the placebo control group at the 6-month follow-up assessment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Form 1 students
  • able to speak Cantonese and read Chinese, and
  • from low-income families (with a half-median monthly household income or the recipients of Comprehensive Social Security Assistance)

Exclusion Criteria:

  • Children with identified cognitive or learning problems, chronic illness, or physical disabilities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Participants in the intervention group will be invited to join the mountain craft training programme.
Other: Intervention
The training programme will consist of a 3-hour lecture. The contents of the lecture will include knowledge of mountaineering in Hong Kong, country codes and care for the environment, environmental awareness when undertaking outdoor activities, hiking skills, knowledge and choice of hiking equipment and clothing, trip planning, mountain safety, map reading, the use of a compass, mountain safety, basic first aid, methods of calling for help in an emergency and sources of weather data. After completing the lecture, participants will be required to join a 6-day hiking training programme on weekends within a 3-month period (each training will be at least 5 kilometres and the duration will be at least 4 hours).
Placebo Comparator: Placebo control group
Participants will be invited to join a control intervention that mimics the time and attention received by participants in the intervention group but will be designed to have no specific effect on the outcome variables.
Other: Placebo
Control participants will be asked to join six day-time leisure activities on weekends within a 3-month period. Leisure activities will be organised by the Asbury Methodist Social Service and will include cartoon film shows, handicraft workshops, chess games, health talks on the prevention of influenza and eating a healthy diet, and day visits to a museum and theme park. Children in the placebo control group will receive free access to leisure activities, including visits to museums and theme parks as an incentive for his/her participation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Resilience Scale-14 (RS-14)
Time Frame: baseline, 3-month, and 6-month
The RS-14 will be used to measure participants' resilience. The RS-14 measures two factors: personal competence and acceptance of self and life.24 Each item is answered on a 7-point Likert scale from 'strongly disagree' to 'strongly agree', with total scores ranging from 14 to 98. Higher scores indicate higher levels of resilience. The RS-14 has been translated into Chinese and used to measure children's resilience in a previous study.25 The psychometric properties of the Chinese version of the RS-14 have been tested, with a test-retest reliability of .84 and internal consistency (Cronbach's α) of .86.
baseline, 3-month, and 6-month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Chinese version of the Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
Time Frame: baseline, 3-month, and 6-month
Participants' depressive symptoms will be evaluated using the CES-DC, which contains 20 completely standardized items to assess depressive symptoms. All items are scored on a 4-point self-report scale ranging from 0 to 3 corresponding to their occurrence in the previous week. Total scores range from 0 to 60, with higher scores indicating more prominent symptomatology. The psychometric properties of the Chinese version of the CES-DC have been tested; the version has a high content legitimacy (content legitimacy index = 95%) and satisfactory internal consistency reliability (r = 0.82).
baseline, 3-month, and 6-month
Chinese version of Rosenberg's Self-Esteem Scale (RSES)
Time Frame: baseline, 3-month, and 6-month
Participants' self-esteem will be evaluated using the RSES, which contains includes 10 items intended to evaluate the self-esteem of children and adolescents worldwide. Each item is scored on a 4-point Likert scale ranging from 1 to 4, with total scores ranging from 10 to 40. Higher scores demonstrate higher levels of self-esteem. The Chinese version of the RSES has recently been used in Chinese children, and has shown sufficient internal reliability (r = 0.84).
baseline, 3-month, and 6-month
The children's peak expiratory flow rate
Time Frame: baseline, 3-month, and 6-month
A miniWright Standard Handheld peak flow meter will be used for measuring peak expiratory flow rate.
baseline, 3-month, and 6-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSEARS20221110002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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