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

• ClinicalTrials.gov Identifier: NCT03050580
• Recruitment Status: Completed
• First Posted: February 13, 2017
• Last Update Posted: February 13, 2017
• Sponsor: The University of Hong Kong
• Information provided by (Responsible Party): Dr. Anna W.M. Choi, The University of Hong Kong

Tracking Information

• First Submitted Date: February 1, 2017
• First Posted Date: February 13, 2017
• Last Update Posted Date: February 13, 2017
• Actual Study Start Date: January 1, 2013
• Actual Primary Completion Date: November 30, 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 10, 2017)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: February 10, 2017)

• 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)
• 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.
• 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).
• 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).
• 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).
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Evaluation of the "Treatment Group Model for Abused Women" in Shelters in Hong Kong
• Official Title: An Evaluation of the "Treatment Group Model for Abused Women" in Shelters in 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.
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Abused Women

Intervention

• 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
• 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

Study Arms

• 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.
  Intervention: Behavioral: self-esteem enhancement 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.
  Intervention: Behavioral: Standard care for abused women

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 10, 2017): 122
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 30, 2015
• Actual Primary Completion Date: November 30, 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03050580
• Other Study ID Numbers: UW12-557
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Dr. Anna W.M. Choi, The University of Hong Kong
• Study Sponsor: The University of Hong Kong
• Collaborators: Not Provided

Investigators

• Principal Investigator: Anna Choi, PhD; annachoi@socwork.hku.hk

• PRS Account: The University of Hong Kong
• Verification Date: February 2017