Enhancing Family Well-being Project

This study has been completed.
Sponsor:
Collaborator:
Hong Kong Jockey Club and Hong Kong Social Welfare Department
Information provided by (Responsible Party):
Prof. Sophia Siu-chee Chan, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01720992
First received: August 30, 2012
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

Background: Shamshuipo District has the highest proportion of low income families, and a relatively large percentage of single parents, elderly, new immigrants among all districts in Hong Kong (Census and Statistics Department, 2011). In addition to provide these families substantial support, a campaign to enhance their family well-being is needed.

Aim: This project is conducted to enhance their family relationship as well as family happiness, health and harmony (3Hs) among families in the Shamshuipo District, through a community-based intervention programme combined with a planning tool (booklet).

Methods: This project adopts a cluster-randomized controlled design, with the application of positive psychology concepts as a theoretical framework. A community-based participatory (CBP) approach, which is an effective way to engage public health researchers and community members (NGOs, other major stakeholders, and participants), will be used. Both quantitative and qualitative methods will be used in the evaluation of major outcomes (participants' family relationship and 3Hs) at different time points throughout the project. Process evaluation will be performed to evaluate the process of each component of the project.

Procedure: This project will be conducted in three phases.

Phase 1 includes planning, implementation, and evaluation of a training programme for social workers from the 30 participating NGOs. The social workers will be equipped with the knowledge and skills of the application of positive psychology as well as logic model. This phase also includes the launching event to arouse public awareness of the project.

Phase 2 includes designing, delivering, and evaluating 30 community-based intervention programmes. A planning tool (designed as a booklet) will be distributed to participants of the intervention group in the form of 'homework assignment' immediate after the intervention programme; whereas participants of the control group will receive the booklet upon the completion of the three months follow-up questionnaire assessment. This phase also contains focus group interviews among participants to collect their experiences, feelings and changes in families after attending the intervention programme. Focus groups among social workers will be conducted afterwards to explore their barriers and facilitators in programme implementation; as well as their personal and/or collective growth in conducting the project. In-depth interview among community stakeholders will be held to explore the social impact of the CBPR project, and collect their suggestions for future implementation.

Phase 3 is a dissimilation phase that the "Positive Family Education Booklet" and "Positive Family Practice Manual" will be released. A practice wisdom forum for social workers and other major stakeholders will also be organized to share their experiences in conducting the community-based programmes.

Primary hypothesis: Families participated in a community-based programme and received a toolkit (intervention group) have higher scores in their family relationship and family 3Hs than families who participated in a community-based programme only (control group).

Secondary hypotheses: (1) Participants' attitudes towards and intention of practising the suggested behaviours will be increased immediately after their participation in the community-based intervention programme; (2) Participants' attitudes towards, their intention, as well as frequency of practising the suggested behaviours will remain higher at 6 weeks and 3 months after the intervention compared to the corresponding figures of pre-intervention (baseline); (3) Participants' scores of family relationship and 3Hs will be significantly higher at 6 weeks and 3 months after their participation in the intervention.


Condition Intervention
Family Relationship, Family Health, Happiness and Harmony
Other: A theory-based action planning toolkit

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Enhancing Family Well-being Project

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Changes in Family relationship from baseline to 3 months after intervention [ Time Frame: Pre-intervention programs (Up to 2 weeks before), post-intervention programs (Up to 2 weeks after), six weeks and three months after intervention programs ] [ Designated as safety issue: No ]
    Family relationship will be assessed by a 'Family relationship scale'of Family environmental scale.

  • Changes in family happiness from baseline to 3 months after intervention [ Time Frame: Pre-intervention programs (Up to 2 weeks before), post-intervention programs (Up to 2 weeks after), six weeks and three months after intervention programs ] [ Designated as safety issue: No ]
    Happiness will be determined by Subjective Happiness Scale and the one item question adopted from Subramanian et al. Self-perceived happiness at the individual and family level will also be assessed by a 0-10 score at 4 time points.In addition to the quantitative methods described above, qualitative method (focus group) will be conducted to evaluate the primary outcomes.

  • Changes in family health from baseline to 3 months after intervention [ Time Frame: Pre-intervention programs (Up to 2 weeks before), post-intervention programs (Up to 2 weeks after), six weeks and three months after intervention programs ] [ Designated as safety issue: No ]
    Health will be evaluated by the SF-12v2 Health Survey. Harmony will be assessed by a 12-item scale. Self-perceived health, at the individual and family level will also be assessed by a 0-10 score at 4 time points.In addition to the quantitative methods described above, qualitative method (focus group) will be conducted to evaluate the primary outcomes.

  • Changes in family harmony from baseline to 3 months after intervention [ Time Frame: Pre-intervention programs (Up to 2 weeks before), post-intervention programs (Up to 2 weeks after), six weeks and three months after intervention programs ] [ Designated as safety issue: No ]
    Harmony will be assessed by a 12-item scale. Self-perceived harmony, at the individual and family level will also be assessed by a 0-10 score at 4 time points.In addition to the quantitative methods described above, qualitative method (focus group) will be conducted to evaluate the primary outcomes.


Secondary Outcome Measures:
  • Changes in Participants' attitudes towards, intention and frequency of performing the suggested behaviors from baseline to 3 months after intervention [ Time Frame: Pre-intervention program (Up to 2 weeks before) (T1), immediate post- intervention program (Up to 2 weeks after) (T2), six weeks (T3) and three months (T4) after intervention programs. ] [ Designated as safety issue: No ]
    Questionnaire will be used to evaluate the changes in participants' attitudes towards, intention and frequency of performing the suggested behaviors from baseline to 3 months after intervention

  • Changes in Social workers' knowledge of the application of positive psychology in the CBPR project before and after training session [ Time Frame: Pre- and post- training session (Up to 2 weeks before and after); as well as a 6-month, and 12-month follow-up ] [ Designated as safety issue: No ]
    Questionnaire will be used to investigate the changes in Social workers' knowledge of the application of positive psychology in the CBPR project before and after training session

  • The process of community-based intervention programme [ Time Frame: Observe in every session of the community-based intervention programme, including core intervention session, booster session (6 weeks after the core intervention), and tea-gathering (3 months after the core intervention). ] [ Designated as safety issue: No ]
    Assessed by a Process Evaluation onsite observation form, and a series of checklists including Resources input record sheet, Participants' attendance form, Programme rundown, Booklet record form, and NGOs' final report. The components of process evaluation, including context, reach, dose delivered, dose received, fidelity and recruitment will be assessed.

  • The social impact of the CBPR project [ Time Frame: Post intervention program (Up to 3 months after) ] [ Designated as safety issue: No ]
    Evaluated by conducting community stakeholders' in-depth interviews.

  • Changes in social workers' attitudes of the application of logic model in the CBPR project before and after training session [ Time Frame: Pre- and post- training (Up to 2 weeks before and after) ; as well as a 6-month, and 12-month follow-up ] [ Designated as safety issue: No ]
    Questionnaire will be used to access the changes in social workers' attitudes of the application of logic model in the CBPR project before and after training session

  • Changes in Social workers' self-competency of the application of process evaluation in the CBPR project before and after training session [ Time Frame: Pre- and post- training (Up to 2 weeks before and after); as well as a 6-month, and 12-month follow-up ] [ Designated as safety issue: No ]
    Questionnaire will be used to evaluate the changes in social workers' self-competency of the application of process evaluation in the CBPR project before and after training session

  • Changes in Social workers' attitude of the application of positive psychology in the CBPR project before and after training session [ Time Frame: Pre- and post- training session (Up to 2 weeks before and after); as well as a 6-month, and 12-month follow-up ] [ Designated as safety issue: No ]
    Questionnaire will be used to access the changes in social workers' attitude of the application of positive psychology in the CBPR project before and after training session

  • Changes in Social workers' self-competency of the application of positive psychology in the CBPR project before and after training session [ Time Frame: Pre- and post- training session (Up to 2 weeks before and after); as well as a 6-month, and 12-month follow-up ] [ Designated as safety issue: No ]
    Questionnaire will be used to access the changes in social workers' self-competency of the application of positive psychology in the CBPR project before and after training session

  • Changes in social workers' knowledge of the application of logic model in the CBPR project before and after training session [ Time Frame: Pre- and post- training (Up to 2 weeks before and after) ; as well as a 6-month, and 12-month follow-up ] [ Designated as safety issue: No ]
    Questionnaire will be used to investigate the changes in social workers' knowledge of the application of logic model in the CBPR project before and after training session

  • Changes in social workers' self-competency of the application of logic model in the CBPR project before and after training session [ Time Frame: Pre- and post- training (Up to 2 weeks before and after) ; as well as a 6-month, and 12-month follow-up ] [ Designated as safety issue: No ]
    Questionnaire will be used to evaluate the changes in social workers' self-competency of the application of logic model in the CBPR project before and after training session

  • Changes in Social workers' knowledge of the application of process evaluation in the CBPR project before and after training session [ Time Frame: Pre- and post- training (Up to 2 weeks before and after) ; as well as a 6-month, and 12-month follow-up ] [ Designated as safety issue: No ]
    Questionnaire will be used to evaluate the changes in social workers' knowledge of the application of process evaluation in the CBPR project before and after training session

  • Changes in Social workers' attitude of the application of process evaluation in the CBPR project before and after training session [ Time Frame: Pre- and post- training (Up to 2 weeks before and after) ; as well as a 6-month, and 12-month follow-up ] [ Designated as safety issue: No ]
    Questionnaire will be used to access the changes in social workers' attitude of the application of process evaluation in the CBPR project before and after training session

  • Changes in Participants' intention of performing the suggested behaviours from baseline to 3 months after intervention [ Time Frame: Pre-intervention program (Up to 2 weeks before) (T1), immediate post- intervention program (Up to 2 weeks after) (T2), six weeks (T3) and three months (T4) after intervention programs. ] [ Designated as safety issue: No ]
    Questionnaire will be used to evaluate the changes in participants' attitudes towards, intention and frequency of performing the suggested behaviours from baseline to 3 months after intervention

  • Changes in Participants' frequency of performing the suggested behaviors from baseline to 3 months after intervention [ Time Frame: Pre-intervention program (Up to 2 weeks before) (T1), immediate post- intervention program (Up to 2 weeks after) (T2), six weeks (T3) and three months (T4) after intervention programs. ] [ Designated as safety issue: No ]
    Questionnaire will be used to evaluate the changes in participants' attitudes towards, intention and frequency of performing the suggested behaviors from baseline to 3 months after intervention


Estimated Enrollment: 2400
Study Start Date: March 2012
Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
A theory-based action planning toolkit will be distributed to Group A participants.
Other: A theory-based action planning toolkit
The toolkit will be distributed to the participants for their use at home, like a 'homework assignment', for the purpose of enhancing their intention and practices of the suggested behaviours. The development of the booklet was guided by the theory of The Health Action Process Approach (HAPA), which suggests that one's intention can be foster by knowing that the new behaviour has positive outcomes as opposed to the negative outcomes that accompany the current behaviour; and planning (action planning and coping planning) serves as an operative mediator between intentions and behaviour (Schwarzer, 2008). Previous evidence has shown the applicability of the HAPA in changing people's health behaviours, e.g., physical exercise, breast self-examination, seat belt use, dietary behaviours, and dental flossing; and its generalizability has been confirmed by Schwarzer (2008).
Group B
Group B is a wait list control
Other: A theory-based action planning toolkit
The toolkit will be distributed to the participants for their use at home, like a 'homework assignment', for the purpose of enhancing their intention and practices of the suggested behaviours. The development of the booklet was guided by the theory of The Health Action Process Approach (HAPA), which suggests that one's intention can be foster by knowing that the new behaviour has positive outcomes as opposed to the negative outcomes that accompany the current behaviour; and planning (action planning and coping planning) serves as an operative mediator between intentions and behaviour (Schwarzer, 2008). Previous evidence has shown the applicability of the HAPA in changing people's health behaviours, e.g., physical exercise, breast self-examination, seat belt use, dietary behaviours, and dental flossing; and its generalizability has been confirmed by Schwarzer (2008).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. For the launching event, the community-based programmes, and focus groups of participants:

    Participants aged six or above, who can communicate with social workers, and who are currently residing in Shamshuipo District /are service users of the corresponding NGO/ are students in Shamshuipo District. Participants who are between six and eight years old are required to be assisted individually by social workers in completing questionnaires.

  2. For the social workers' training programme, the practice wisdom forum, focus groups of social workers:

    Social or community workers who can read Chinese and speak Cantonese, and are currently working in selected social service organizations or government agencies in the Shamshuipo District.

  3. In-depth interviews of community stakeholders:

Community stakeholders who can read Chinese and speak Cantonese, and are currently working in the social service organizations (participate or not participant in this project) or government agencies in the Shamshuipo District.

Exclusion Criteria:

  • Participants who fail to meet the inclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720992

Locations
China
The University of Hong Kong
Hong Kong SAR, China
Sponsors and Collaborators
The University of Hong Kong
Hong Kong Jockey Club and Hong Kong Social Welfare Department
  More Information

No publications provided

Responsible Party: Prof. Sophia Siu-chee Chan, Professor & Research Director, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01720992     History of Changes
Other Study ID Numbers: EFWBP
Study First Received: August 30, 2012
Last Updated: February 3, 2014
Health Authority: Hong Kong: Ethics Committee

ClinicalTrials.gov processed this record on July 29, 2014