Self-efficacyNCT02770898
Improving Family Holistic Health in Probationers
A study testing Family Holistic Health in people with Self-efficacy and Self-esteem, run by The University of Hong Kong at 1 site in China.
Trial summary
Evaluating the impact of probation on probationers is necessary for both effective practice of probation officers and their assessment of the success of their work. At present, there are limited studies that have evaluated the impact of probation services on probationers and their family. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Self-efficacy, Self-esteem, Family Relationship
- What is being tested?
- Family Holistic Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 463 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Be an existing probationer with 6 months of term remaining
- Reading and writing abilities for questionnaire completion
- Have family members that are based in Hong Kong (the rationale is that one of the secondary outcome is to improve family relations)
- Probationer does not have a developmental or intellectual disability
- Probationer aged 13 and above (the rationale is that youth under 12 years of age may not have the cognitive ability to complete questionnaires)
Who cannot join
- Sexual offenders
- Drug offenders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Family Holistic Health in Probationers- a Mixed Methods Evaluation
Evaluating the impact of probation on probationers is necessary for both effective practice of probation officers and their assessment of the success of their work. At present, there are limited studies that have evaluated the impact of probation services on probationers and their family. There are even fewer studies that have examined interventions on probationers' well-being and family relations in a Chinese society. Compared with the general population, probationers are associated with poorer mental (e.g., depression, lower levels of self-esteem, high level of stress) and physical health, and often experience higher levels of family conflict, and poorer quality of family relationships. Given the vulnerabilities, there is a need to strengthen and promote healthy lifestyle and enhance individual and family well-being among probationers. As part of the FAMILY project, the current study focuses on "FAMILY Holistic Health" which emphasizes a comprehensive approach to improving physical, mental, and social health and well-being. This project will be conducted as a pilot project in the Social Welfare Department (SWD) in the Eastern District of Hong Kong. Interventions will be delivered to promote and enhance probationer's wellbeing, as well as enhancing FAMILY 3Hs (Happiness, Health, and Harmony). Training programs will be provided to probation officers and/or workers of SWD in order to equip them with knowledge and skills in implementing health-related family intervention programs.
Read the detailed description
To enhance individual and family well-being among probationers, family life and health education, including the skills and knowledge for physical exercise, healthy family functioning, strong communication skills, healthy interpersonal relationships, and positive self-esteem, should be strengthened and promoted. Based on the strong foundation of the FAMILY projects conducted by our research team in the past years, this project seeks to promote "FAMILY holistic health" for targeted families (i.e. probationers). The holistic health interventions are interactive and designed for behavioral changes to enhance individual well-being and encourage positive and sustainable health actions among family members. Thus, it is expected ultimately that the participants and their family members could enhance their family happiness, health, and harmony (3Hs). In sum, the project has the following contributions:
- Strengthen evidence-based practice Hong Kong probation-related topics are scarcely studied. There is a need for rigorous studies to build and strengthen evidence-base for probation services. This study will be one of the first studies to evaluate the effectiveness of probation services on individual well-being and family well-being utilizing a mixed-methods approach.
- Stakeholder engagement Stakeholders will be engaged throughout the research process. This promotes co-learning and empowering process, builds on strengths and resources within the community, and integrates knowledge and intervention for the mutual benefit of all partners.
- Train-the-trainer program Training will be provided to probation officers and/or workers at the Social Welfare Department. The result of this train-the-trainers program is that front-line service workers will increase and enhance their knowledge and skills to independently and effectively carry out interventions. Probation officers will act as role models for probationers and continue to implement our knowledge and techniques in their future interventions.
- Conditions
- Self-efficacy, Self-esteem, Family Relationship
- Being tested
- Family Holistic Health
- Keywords
- probation, evidence-based, well-being, physical exercise, family well-being
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Holistic HealthBehavioural
Interventions for probationers will aim to promote physical and psychosocial health, family relationships and Family 3H (happiness, harmony and health).
| Study group | Role | What they receive |
|---|---|---|
| Brief Intervention | Experimental | The brief intervention is individual focus and consists of three main components, which include enhancing the individual personal attributes such as participant's knowledge, values, and behaviors related to physical exercise. Second, the intervention will promote changes in behavioral attributes by providing opportunities and experience in goal setting, skills development in physical exercise and self-monitoring. Finally, the brief intervention promotes family relations and well-being by encouraging individuals to share their knowledge and increase physical activities with other family members. The brief intervention will be delivered by the probation officer during regular monthly consultation. Receives: Behavioral: Family Holistic Health |
| Combined Intervention | Experimental | Participants allocated to the combined intervention will receive the individual brief intervention and participate in a community group program. The components in the brief intervention will also be reinforced in the group program. The group nature is designed to create an environment that is supportive of physical exercise, through role models, peer support, and encourages families to exercise with probationers. Receives: Behavioral: Family Holistic Health |
| Care-as-usual | No intervention | Participants allocated to Care-as-usual arm will receive their usual services. Participants will be offered the combined interventions upon completion of 3-months follow up assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Individual well-being (self-esteem, self-efficacy)
Individual well-being will be assessed by the Rosenberg Self-esteem Scale.
Measured: T1 (baseline), T2 (one month follow-up), T3 (three months follow-up)
Secondary outcomes (6)
Physical health
Physical health will be assessed by the SF-12v2 health survey.
Measured: T1 (baseline), T2 (one month follow-up), T3 (three months follow-up)
Psychosocial health
Psychosocial health will be assessed by the SF-12v2 health survey.
Measured: T1 (baseline), T2 (one month follow-up), T3 (three months follow-up)
Behaviours on physical exercise (Adapted version of IPAC)
Theme-related behaviours will be assessed by behavioural indicators.
Measured: T1 (baseline), T2 (one month follow-up), T3 (three months follow-up)
Family health, happiness and harmony (3Hs)
Family 3Hs will be assessed by the family well-being scale.
Measured: T1 (baseline), T2 (one month follow-up), T3 (three months follow-up)
Family relations
Family relations will be assessed by the family APGAR scale.
Measured: T1 (baseline), T2 (one month follow-up), T3 (three months follow-up)
Satisfaction towards the program (Self-generated satisfaction scale)
Satisfaction towards the program will be assessed by a program evaluation measure.
Measured: T1 (baseline), T2 (one month follow-up), T3 (three months follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startJul 2015
- Primary completionMar 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Self-efficacyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770898
- Sponsor's protocol ID
- UW 15-249
- Status last verified
- May 2018
- First submitted
- 23 Nov 2015
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Lai AY, Sit SM, Thomas C, Cheung GO, Wan A, Chan SS, Lam TH. A Randomized Controlled Trial of a Positive Family Holistic Health Intervention for Probationers in Hong Kong: A Mixed-Method Study. Front Psychol. 2021 Dec 7;12:739418. doi: 10.3389/fpsyg.2021.739418. eCollection 2021.
PubMed 34950083
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Family Holistic Health in Probationers- a Mixed Methods Evaluation
- ClinicalTrials.gov ID
- NCT02770898
- Acronym / sponsor ID
- UW 15-249
- Conditions
- Self-efficacy, Self-esteem, Family Relationship
- Keywords
- probation, evidence-based, well-being, physical exercise, family well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating the impact of probation on probationers is necessary for both effective practice of probation officers and their assessment of the success of their work. At present, there are limited studies that have evaluated the impact of probation services on probationers and their family. There are even fewer studies that have examined interventions on probationers' well-being and family relations in a Chinese society. Compared with the general population, probationers are associated with poorer mental (e.g., depression, lower levels of self-esteem, high level of stress) and physical health, and often experience higher levels of family conflict, and poorer quality of family relationships. Given the vulnerabilities, there is a need to strengthen and promote healthy lifestyle and enhance individual and family well-being among probationers. As part of the FAMILY project, the current study focuses on "FAMILY Holistic Health" which emphasizes a comprehensive approach to improving physical, mental, and social health and well-being. This project will be conducted as a pilot project in the Social Welfare Department (SWD) in the Eastern District of Hong Kong. Interventions will be delivered to promote and enhance probationer's wellbeing, as well as enhancing FAMILY 3Hs (Happiness, Health, and Harmony). Training programs will be provided to probation officers and/or workers of SWD in order to equip them with knowledge and skills in implementing health-related family intervention programs.
Detailed description
To enhance individual and family well-being among probationers, family life and health education, including the skills and knowledge for physical exercise, healthy family functioning, strong communication skills, healthy interpersonal relationships, and positive self-esteem, should be strengthened and promoted. Based on the strong foundation of the FAMILY projects conducted by our research team in the past years, this project seeks to promote "FAMILY holistic health" for targeted families (i.e. probationers). The holistic health interventions are interactive and designed for behavioral changes to enhance individual well-being and encourage positive and sustainable health actions among family members. Thus, it is expected ultimately that the participants and their family members could enhance their family happiness, health, and harmony (3Hs). In sum, the project has the following contributions:
- Strengthen evidence-based practice Hong Kong probation-related topics are scarcely studied. There is a need for rigorous studies to build and strengthen evidence-base for probation services. This study will be one of the first studies to evaluate the effectiveness of probation services on individual well-being and family well-being utilizing a mixed-methods approach.
- Stakeholder engagement Stakeholders will be engaged throughout the research process. This promotes co-learning and empowering process, builds on strengths and resources within the community, and integrates knowledge and intervention for the mutual benefit of all partners.
- Train-the-trainer program Training will be provided to probation officers and/or workers at the Social Welfare Department. The result of this train-the-trainers program is that front-line service workers will increase and enhance their knowledge and skills to independently and effectively carry out interventions. Probation officers will act as role models for probationers and continue to implement our knowledge and techniques in their future interventions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brief Intervention | Experimental | Behavioral: Family Holistic HealthThe brief intervention is individual focus and consists of three main components, which include enhancing the individual personal attributes such as participant's knowledge, values, and behaviors related to physical exercise. Second, the intervention will promote changes in behavioral attributes by providing opportunities and experience in goal setting, skills development in physical exercise and self-monitoring. Finally, the brief intervention promotes family relations and well-being by encouraging individuals to share their knowledge and increase physical activities with other family members. The brief intervention will be delivered by the probation officer during regular monthly consultation. |
| Combined Intervention | Experimental | Behavioral: Family Holistic HealthParticipants allocated to the combined intervention will receive the individual brief intervention and participate in a community group program. The components in the brief intervention will also be reinforced in the group program. The group nature is designed to create an environment that is supportive of physical exercise, through role models, peer support, and encourages families to exercise with probationers. |
| Care-as-usual | No intervention | –Participants allocated to Care-as-usual arm will receive their usual services. Participants will be offered the combined interventions upon completion of 3-months follow up assessment. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Be an existing probationer with 6 months of term remaining
- Reading and writing abilities for questionnaire completion
- Have family members that are based in Hong Kong (the rationale is that one of the secondary outcome is to improve family relations)
- Probationer does not have a developmental or intellectual disability
- Probationer aged 13 and above (the rationale is that youth under 12 years of age may not have the cognitive ability to complete questionnaires)
Key exclusion criteria (2 listed)
- Sexual offenders
- Drug offenders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Holistic HealthInterventions for probationers will aim to promote physical and psychosocial health, family relationships and Family 3H (happiness, harmony and health). | Behavioural | Brief Intervention, Combined Intervention |
Primary outcome
Changes in Individual well-being (self-esteem, self-efficacy)
Time frame: T1 (baseline), T2 (one month follow-up), T3 (three months follow-up)
Individual well-being will be assessed by the Rosenberg Self-esteem Scale.
6 secondary outcomes
Physical health
Time frame: T1 (baseline), T2 (one month follow-up), T3 (three months follow-up)
Psychosocial health
Time frame: T1 (baseline), T2 (one month follow-up), T3 (three months follow-up)
Behaviours on physical exercise (Adapted version of IPAC)
Time frame: T1 (baseline), T2 (one month follow-up), T3 (three months follow-up)
Family health, happiness and harmony (3Hs)
Time frame: T1 (baseline), T2 (one month follow-up), T3 (three months follow-up)
Family relations
Time frame: T1 (baseline), T2 (one month follow-up), T3 (three months follow-up)
Satisfaction towards the program (Self-generated satisfaction scale)
Time frame: T1 (baseline), T2 (one month follow-up), T3 (three months follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Derived from this study: PubMed 34950083Lai AY, Sit SM, Thomas C, Cheung GO, Wan A, Chan SS, Lam TH. A Randomized Controlled Trial of a Positive Family Holistic Health Intervention for Probationers in Hong Kong: A Mixed-Method Study. Front Psychol. 2021 Dec 7;12:739418. doi: 10.3389/fpsyg.2021.739418. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Holistic Health in people with Self-efficacy and Self-esteem, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Individual well-being (self-esteem, self-efficacy) (time frame: T1 (baseline), T2 (one month follow-up), T3 (three months follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02770898, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.