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

10 febbraio 2017 aggiornato da: Dr. Anna W.M. Choi, The University of Hong Kong
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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

122

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altri nomi:
  • experimental/treatment group
Comparatore attivo: 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.
Altri nomi:
  • gruppo di controllo

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes of self-esteem from baseline to 3 months
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Basic demographics data questionnaire
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Anna Choi, PhD, annachoi@socwork.hku.hk

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2013

Completamento primario (Effettivo)

30 novembre 2014

Completamento dello studio (Effettivo)

30 giugno 2015

Date di iscrizione allo studio

Primo inviato

1 febbraio 2017

Primo inviato che soddisfa i criteri di controllo qualità

10 febbraio 2017

Primo Inserito (Effettivo)

13 febbraio 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 febbraio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 febbraio 2017

Ultimo verificato

1 febbraio 2017

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • UW12-557

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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