NCT03050580

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 13, 2017

Completed
Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

1.9 years

First QC Date

February 1, 2017

Last Update Submit

February 10, 2017

Conditions

Keywords

Abused womentreatment groupfamily violence

Outcome Measures

Primary Outcomes (1)

  • Changes of self-esteem from baseline to 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 Outcomes (6)

  • Basic demographics data questionnaire

    Baseline

  • Social support

    Baseline; 3 months

  • Level of depression

    Baseline; 3 months

  • Post-traumatic Stress Disorder symptoms

    Baseline; 3 months

  • Quality of life

    Baseline; 3 months

  • +1 more secondary outcomes

Study Arms (2)

Self-esteem enhancement group

EXPERIMENTAL

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

Standard care

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: experimental/treatment group
Self-esteem enhancement group

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.

Also known as: control group
Standard care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Standard of CareControl Groups

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Anna Choi, PhD

    annachoi@socwork.hku.hk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 1, 2017

First Posted

February 13, 2017

Study Start

January 1, 2013

Primary Completion

November 30, 2014

Study Completion

June 30, 2015

Last Updated

February 13, 2017

Record last verified: 2017-02