- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04725266
A Family-based Intervention for Drug-abusing Adults in Hong Kong
A Family-based Intervention for Drug-abusing Adults in Hong Kong: A Quasi-experimental Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kowloon, Hong Kong
- Recruiting
- Neo-Horizon of Hong Kong Sheng Kung Hui Welfare Council Limited
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria for intervention group:
- Adults aged 18 to 55
- Have used drugs in the past 90 days
- At the time of case recruitment, the subject is engaged in an intimate relationship with a spouse/partner, or having a child/children
- Understand oral and written Chinese
Exclusion criteria for intervention group:
- Taking other treatments during intervention
- The spouse or child of DA are not available to participate in the program
Inclusion criteria for comparison group:
- Adults aged 18 to 55
- Have used drugs in the past 90 days
- Understand oral and written Chinese
Exclusion criteria for comparison group:
1. Taking other treatments during intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: family-based intervention plus routine care
This group of participants including drug abusers and their families will be receiving family-based intervention which is a well-designed intervention with group sessions and routine care provided by professional social workers in local social service center.
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The intervention aims to motivate drug abusers to stay drug abstinence and improve family functioning with the support of their own families.
In the component of engagement, we will use effective and appropriate skills to engage clients, understand their concerns, and provide necessary resources to them.
In the component of role identification, we will help drug abusers identify their family roles through providing education on family roles and responsibilities.
The component of affection is designed to learn affective responsiveness and enhance their emotional bonds with each other, while in the component of competence, we will enhance their competency to take care of the family.
The intervention will be conducted in group sessions with 4-6 families per group.
A total of 10 sessions will be delivered with 1.5-2 hour for each session (3 sessions for role identification, 4 sessions for affection, and 3 sessions for competence).
Routine care includes individual-session components of engagement, case assessment, drug education, service referral, family support, and etc.
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ACTIVE_COMPARATOR: routine care
The group of participants will receive routine care which is widely used in social service providers and mainly includes individual counselling service for drug abusers.
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Routine care includes individual-session components of engagement, case assessment, drug education, service referral, family support, and etc.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline measurements of frequency of drug use at 1-, 2-, and 4-months
Time Frame: Baseline,1-, 2-, and 4-months
|
Changes in scores on frequency of drug use is measured by Frequency of Drug Use in Past Three Months by Beats Drug Fund. A higher score suggests a higher frequency of drug use. |
Baseline,1-, 2-, and 4-months
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Changes from baseline measurements of drug abstinence at 1-, 2-, and 4-months
Time Frame: Baseline,1-, 2-, and 4-months
|
Changes in scores on drug abstinence is assessed by Timeline Followback (TLFB) in which participants will report the specific date and time of using drugs in the past one month. A higher score suggests a longer time for drug abstinence. |
Baseline,1-, 2-, and 4-months
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Changes from baseline measurement of craving for drugs at 1-, 2-, and 4-months
Time Frame: Baseline,1-, 2-, and 4-months
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Changes in scores on cravings for drugs is measured by the Chinese version of Craving Beliefs Questionnaire (CCBQ) on a 5-point Likert scale ranging from totally disagree (1) to totally agree (5). A higher score on the scale suggests a higher level of drug cravings |
Baseline,1-, 2-, and 4-months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline measurement of marital affection at 1-, 2-, and 4-months
Time Frame: Baseline,1-, 2-, and 4-months
|
Changes in scores on marital affection will be measured by the Chinese version of Dyadic Adjustment Scale (C-DAS) with good psychometric properties. A higher score on this scale indicates a higher level of marital affection. |
Baseline,1-, 2-, and 4-months
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Changes from baseline measurement of marital satisfaction at 1-, 2-, and 4-months
Time Frame: Baseline,1-, 2-, and 4-months
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Changes in scores on marital satisfaction will be assessed Kansas Marital Satisfaction Scale (KMS) in Chinese, scoring on a 5-point Likert scale ranging from 1 (not very satisfied) to 5 (very satisfied). A higher score indicates a higher level of marital satisfaction. |
Baseline,1-, 2-, and 4-months
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Changes from baseline measurement of family functioning at 1-, 2-, and 4-months
Time Frame: Baseline,1-, 2-, and 4-months
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Changes in score on general family functioning will be assessed by Subscale of general functioning of Chinese version of Family Assessment Device (C-FAD). The participants answer each question with a 4-point Likert scale (1=strongly agree, 4=strongly disagree) and the total scores range from 12 to 48. A higher score suggests a higher level of family functioning. |
Baseline,1-, 2-, and 4-months
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Changes from baseline measurement of family communication at 1-, 2-, and 4-months
Time Frame: Baseline,1-, 2-, and 4-months
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Changes in score on general family communication will be assessed by Subscale of family functioning of Chinese version of Family Assessment Device (C-FAD). The participants answer each question with a 4-point Likert scale ranging from 1 (strongly agree) to 4 (strongly disagree). A higher score suggests a higher level of quality of family communication. |
Baseline,1-, 2-, and 4-months
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Changes from baseline measurement of family roles at 1-, 2-, and 4-months
Time Frame: Baseline,1-, 2-, and 4-months
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Changes in score on family roles will be measured by Perceived Family Responsibility Scale (PFRS) on a 7-point scale ranging from strongly disagree to strongly agree. A higher score of family roles suggests that the participants are more responsibility for their families. |
Baseline,1-, 2-, and 4-months
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Changes from baseline measurement of parenting competency at 1-, 2-, and 4-months
Time Frame: Baseline,1-, 2-, and 4-months
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Changes in score on parenting competence is assessed by Parenting Sense of Competency Scale (PSOC). Parents rate their level of agreement with each item by scores ranging from 1 (strongly disagree) to 6 (strongly agree). A higher score indicates a higher level of perceived parenting self-efficacy. |
Baseline,1-, 2-, and 4-months
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Changes from baseline measurement of mental health at 1-, 2-, and 4-months
Time Frame: Baseline,1-, 2-, and 4-months
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Changes in score on mental health will be assessed by the Chinese version of the Patient Health Questionnaire-9 (PHQ-9) on whether they had been bothered by some mental problems in the past two weeks with a 4-point Likert scale ranging from 1 (not at all) to 4 (nearly every day). A higher score suggests a lower level of mental health status. |
Baseline,1-, 2-, and 4-months
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Changes from baseline measurement of Perception of Parenting Behaviors at 1-, 2-, and 4-months
Time Frame: Baseline,1-, 2-, and 4-months
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Changes in score on parenting behaviors will be measured by Chinese version of Parenting Style Scale (CPSS) which is developed to assess the parenting behaviors with two dimensions-responsiveness and demandingness. A higher score indicates a more positive perception of the parenting practice among children. |
Baseline,1-, 2-, and 4-months
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Changes from baseline measurement of co-dependency at 1-, 2-, and 4-months
Time Frame: Baseline,1-, 2-, and 4-months
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Changes in score on co-dependency will be measured by the subscale of subscale of emotional reactivity of Chinese version of the Differentiation of Self Inventory (C-DSI). Participants respond to each of the items using a 6-point Likert-type scale, ranging from 1(not at all true of me) to 6 (very true of me). A higher score on this scale suggests a higher level of co-dependency. |
Baseline,1-, 2-, and 4-months
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200018
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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