Abused WomenNCT03050580
An Evaluation of the "Treatment Group Model for Abused Women" in Shelters in Hong Kong
A study testing self-esteem enhancement group in people with Abused Women, run by The University of Hong Kong.
Trial summary
This is cluster randomized control trial, that aims to evaluate the effectiveness of the treatment group model for abused women in enhancing their self-esteem and reducing the level of depression, in three shelters for abused women of Po Leung Kuk (a social service organization in Hong Kong). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abused Women
- What is being tested?
- self-esteem enhancement group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 30 Jun 2015
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Abused women of family violence aged 18 or older
- Receiving services from shelters of Po Leung Kuk
Who cannot join
- Unable to communicate (possible reasons: dialects used by targets but not understandable by interviewers; mentally challenged)
- Unable to give consent to participate in the study
About this study
This is cluster randomized control trial, that aims to evaluate the effectiveness of the treatment group model for abused women in enhancing their self-esteem and reducing the level of depression, in three shelters for abused women of Po Leung Kuk (a social service organization in Hong Kong). It is hypothesized that subjects in the Treatment Group would report significant improvement in self-esteem, social support, quality of life; reduction in the level of depression, symptoms of Posttraumatic Stress Disorder at 3 months after service delivery.
Read the detailed description
This is cluster randomized control trial, that aims to evaluate the effectiveness of the treatment group model for abused women in enhancing their self-esteem and reducing the level of depression, in three shelters for abused women of Po Leung Kuk (a social service organization in Hong Kong). 50-60 abused women are recruited as treatment group from two randomized shelters of Po Leung Kuk (Shelters A and B), where subjects receive self-esteem enhancement group intervention for abused women. Another 50-60 abused women are recruited as the control group from a randomized shelter of Po Leung Kuk (Shelter C), where subject receive standard shelter services for abused women. It is hypothesized that subjects in the Treatment Group would report significant improvement in self-esteem, social support, quality of life; reduction in the level of depression, symptoms of Posttraumatic Stress Disorder at 3 months after service delivery, are compared to those in the control group.
- Conditions
- Abused Women
- Being tested
- self-esteem enhancement group, Standard care for abused women
- Keywords
- Abused women, treatment group, family violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-esteem enhancement groupBehavioural
Also called experimental/treatment group
Subjects in the treatment group will join a six-session treatment for recognizing their strengths and resources through group activities and sharing. Each session is 1.5-2 hours long, and all sessions are designed for 4-8 abused women. The activities are designed and led with an aim to improve their self-esteem, general health, as well as to reduce the level of depression. This service is provided by registered social workers.
Standard care for abused womenBehavioural
Also called control group
The shelter standard care and services will be provided to the abused women in one randomized shelter. Besides, standard care in shelters includes residential accommodations, emotional support, legal, housing and financial advice and referrals will be given to survivors who reported being abused.
| Study group | Role | What they receive |
|---|---|---|
| Self-esteem enhancement group | Experimental | The self-esteem enhancement group service for abused women will receive a six-session program for recognizing strengths and resources through group activities and sharing. Receives: Behavioral: self-esteem enhancement group |
| Standard care | Active comparator | The shelter standard care for abused women includes residential accommodations, emotional support, legal, housing and financial advice and referral service. Receives: Behavioral: Standard care for abused women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of self-esteem from baseline to 3 months
Confidence in one's own worth or abilities; self-respect; feeling of powerlessness.
Rosenberg Self-Esteem Scale (Rosenberg, 1965) will be used to measure the self-esteem of the participants. This is a 10-item Likert-type scale on a 4-point scale ranging from strongly agree to strongly disagree. The scores for the 10 items are then summed; the higher the score, the higher the participant's self-esteem.
Measured: Baseline; 3 months
Secondary outcomes (6)
Basic demographics data questionnaire
Basic demographics data: Age, ethnicity, marital status, living arrangements with spouse/partner, education level, occupation, immigration status (if applicable), information on support network (family and friend), action plan (e.g., filing divorce, application of Injunctions)
Measured: Baseline
Social support
Self-perceived social support from others
The Interpersonal Support Evaluation List-12 (ISEL-12) (Cohen et al., 1985), will be used to measure social support. It has has good psychometric properties and good internal consistency (Cronbach α = 0.88), was used to measure the perceived social support of abused women. The 12-item questionnaire measures 3 sub-scales consisting of appraisal, belonging and tangible support, each of which has 4 items. Each item scores from 0 (definitely false) to 3 (definitely true) giving a total score ranging from 0 to 36. The higher the score, the more the women perceive that they received social support.
Measured: Baseline; 3 months
Level of depression
Self-report symptoms corresponding to criteria for diagnosing depressive disorders
The Beck Depression Inventory version II (BDI-II) will be used to measure level of depression. It is a self-report instrument for the assessment of symptoms corresponding to criteria for diagnosing depressive disorders (Beck, Steer, \& Brown, 1996). It consists of 21 groups of statements and requires the respondent to choose one statement in each group that best describes her during the previous two weeks. The BDI-II has been translated into Chinese and has demonstrated satisfactory validity and reliability (α ranged from .86 to .87) (Leung, 2001).
Measured: Baseline; 3 months
Post-traumatic Stress Disorder symptoms
Self-report symptoms corresponding to criteria for diagnosing Post-traumatic Stress Disorder symptoms
The Chinese Version of the Impact of Event Scale-Revised (IES-R) (Chen et al., 2005 Wu and Chan, 2003) will be used to assess the PTSD symptoms of participants. This is a 22-items self-report instrument to assess PTSD symptoms after a specific traumatic stressor. There are three subscales, including intrusive, avoidance, and hyperarousal symptoms, corresponding to the three dimensions of the DSM-IV criteria for PTSD (American Psychiatric Association, 1994). Each participant will be asked to indicate the frequency of their distress for each of the 22 items on four point scale (0=not at all, 1=seldom, 3=sometime, 4=often).
Measured: Baseline; 3 months
Quality of life
Health-related quality of life
The SF-12 - Short Form Health Survey (SF-12) will be used to assess health-related quality of life (Ware, Snow \& Kosinski, 1993). It consists of 36 items with one measuring health transition and the remaining 35 grouped under eight scales: physical functioning (PF), role limitation due to physical health problems (role-physical; RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitation due to emotional health problems (role-emotional; RE) and mental health (MH).
Measured: Baseline; 3 months
Spousal violence
Spousal violence includes any form of physical, psychological and sexual abuse between experienced by the abused women.
The Chinese version of the Abuse Assessment Screen (C-AAS) will be used to assess participants for IPV. The C-AAS addresses physical, psychological and sexual abuse. The main difference between the original AAS for women (McFarlane, Parker, Soeken \& Bullock, 1992) and the C-AAS is that the C-AAS addresses emotional and physical abuse separately in both lifetime and the preceding 3 months while the English AAS measures psychological and physical abuse simultaneously for the lifetime period.
Measured: Baseline; 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start1 Jan 2013
- Primary completion30 Nov 2014
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abused WomenStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Anna W.M. Choi, The University of Hong Kong
- Investigators
- Anna Choi, PhD, Principal investigator, annachoi@socwork.hku.hk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050580
- Sponsor's protocol ID
- UW12-557
- Status last verified
- Feb 2017
- First submitted
- 1 Feb 2017
- Last updated
- 13 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the "Treatment Group Model for Abused Women" in Shelters in Hong Kong
- ClinicalTrials.gov ID
- NCT03050580
- Acronym / sponsor ID
- UW12-557
- Conditions
- Abused Women
- Keywords
- Abused women, treatment group, family violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 30 Nov 2014 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 13 Feb 2017 (actual)
- 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.
This is cluster randomized control trial, that aims to evaluate the effectiveness of the treatment group model for abused women in enhancing their self-esteem and reducing the level of depression, in three shelters for abused women of Po Leung Kuk (a social service organization in Hong Kong). It is hypothesized that subjects in the Treatment Group would report significant improvement in self-esteem, social support, quality of life; reduction in the level of depression, symptoms of Posttraumatic Stress Disorder at 3 months after service delivery.
Detailed description
This is cluster randomized control trial, that aims to evaluate the effectiveness of the treatment group model for abused women in enhancing their self-esteem and reducing the level of depression, in three shelters for abused women of Po Leung Kuk (a social service organization in Hong Kong). 50-60 abused women are recruited as treatment group from two randomized shelters of Po Leung Kuk (Shelters A and B), where subjects receive self-esteem enhancement group intervention for abused women. Another 50-60 abused women are recruited as the control group from a randomized shelter of Po Leung Kuk (Shelter C), where subject receive standard shelter services for abused women. It is hypothesized that subjects in the Treatment Group would report significant improvement in self-esteem, social support, quality of life; reduction in the level of depression, symptoms of Posttraumatic Stress Disorder at 3 months after service delivery, are compared to those in the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-esteem enhancement group | Experimental | Behavioral: self-esteem enhancement groupThe self-esteem enhancement group service for abused women will receive a six-session program for recognizing strengths and resources through group activities and sharing. |
| Standard care | Active comparator | Behavioral: Standard care for abused womenThe shelter standard care for abused women includes residential accommodations, emotional support, legal, housing and financial advice and referral service. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Abused women of family violence aged 18 or older
- Receiving services from shelters of Po Leung Kuk
Key exclusion criteria (2 listed)
- Unable to communicate (possible reasons: dialects used by targets but not understandable by interviewers; mentally challenged)
- Unable to give consent to participate in the study
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 |
|---|---|---|
| self-esteem enhancement groupAlso: experimental/treatment groupSubjects in the treatment group will join a six-session treatment for recognizing their strengths and resources through group activities and sharing. Each session is 1.5-2 hours long, and all sessions are designed for 4-8 abused women. The activities are designed and led with an aim to improve their self-esteem, general health, as well as to reduce the level of depression. This service is provided by registered social workers. | Behavioural | Self-esteem enhancement group |
| Standard care for abused womenAlso: control groupThe shelter standard care and services will be provided to the abused women in one randomized shelter. Besides, standard care in shelters includes residential accommodations, emotional support, legal, housing and financial advice and referrals will be given to survivors who reported being abused. | Behavioural | Standard care |
Primary outcome
Changes of self-esteem from baseline to 3 months
Time frame: Baseline; 3 months
Confidence in one's own worth or abilities; self-respect; feeling of powerlessness. Rosenberg Self-Esteem Scale (Rosenberg, 1965) will be used to measure the self-esteem of the participants. This is a 10-item Likert-type scale on a 4-point scale ranging from strongly agree to strongly disagree. The scores for the 10 items are then summed; the higher the score, the higher the participant's self-esteem.
6 secondary outcomes
Basic demographics data questionnaire
Time frame: Baseline
Social support
Time frame: Baseline; 3 months
Level of depression
Time frame: Baseline; 3 months
Post-traumatic Stress Disorder symptoms
Time frame: Baseline; 3 months
Quality of life
Time frame: Baseline; 3 months
Spousal violence
Time frame: Baseline; 3 months
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 13 Feb 2017.
- 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.
Anna Choi, PhD principal investigator
annachoi@socwork.hku.hk
Questions about this trial
What is this clinical trial studying?
A study testing self-esteem enhancement group in people with Abused Women, run by The University of Hong Kong.
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 2 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 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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 of self-esteem from baseline to 3 months (time frame: Baseline; 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2017.