- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03050580
An Evaluation of the "Treatment Group Model for Abused Women" in Shelters in Hong Kong
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
Andre navn:
|
Aktiv komparator: 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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Changes of self-esteem from baseline to 3 months
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Basic demographics data questionnaire
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Anna Choi, PhD, annachoi@socwork.hku.hk
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- UW12-557
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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