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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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 groups in NCT03050580
Study groupRoleWhat they receive
Self-esteem enhancement groupExperimentalThe 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 careActive comparatorThe 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted13 Feb 2017
  2. Study start1 Jan 2013
  3. Primary completion30 Nov 2014
  4. Study completion30 Jun 2015

Resources

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)
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

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.

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