- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03050580
An Evaluation of the "Treatment Group Model for Abused Women" in Shelters in Hong Kong
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
|
Active Comparator: Standard care
The shelter standard care for abused women includes residential accommodations, emotional support, legal, housing and financial advice and referral service.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Baseline; 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Baseline
|
|
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. |
Baseline; 3 months
|
|
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). |
Baseline; 3 months
|
|
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). |
Baseline; 3 months
|
|
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). |
Baseline; 3 months
|
|
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. |
Baseline; 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna Choi, PhD, annachoi@socwork.hku.hk
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UW12-557
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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