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An Evaluation of the "Treatment Group Model for Abused Women" in Shelters in Hong Kong

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03050580
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Anna W.M. Choi, The University of Hong Kong

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Abused Women Behavioral: self-esteem enhancement group Behavioral: Standard care for abused women Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Evaluation of the "Treatment Group Model for Abused Women" in Shelters in Hong Kong
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : November 30, 2014
Actual Study Completion Date : June 30, 2015

Arm Intervention/treatment
Experimental: Self-esteem enhancement group
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.
Behavioral: self-esteem enhancement 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.
Other Name: experimental/treatment group

Active Comparator: Standard care
The shelter standard care for abused women includes residential accommodations, emotional support, legal, housing and financial advice and referral service.
Behavioral: Standard care for abused women
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.
Other Name: control group




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Basic demographics data questionnaire [ Time Frame: Baseline ]
    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)

  2. Social support [ Time Frame: Baseline; 3 months ]

    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.


  3. Level of depression [ Time Frame: Baseline; 3 months ]

    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).


  4. Post-traumatic Stress Disorder symptoms [ Time Frame: Baseline; 3 months ]

    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).


  5. Quality of life [ Time Frame: Baseline; 3 months ]

    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).


  6. Spousal violence [ Time Frame: Baseline; 3 months ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Abused women of family violence aged 18 or older
  • Receiving services from shelters of Po Leung Kuk

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050580


Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Anna Choi, PhD annachoi@socwork.hku.hk
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Responsible Party: Dr. Anna W.M. Choi, Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03050580    
Other Study ID Numbers: UW12-557
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Anna W.M. Choi, The University of Hong Kong:
Abused women
treatment group
family violence