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A Family-based Intervention for Drug-abusing Adults in Hong Kong

Primary Purpose

Drug Abuse

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Family-based intervention
routine care
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Abuse focused on measuring drug abuse

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria for intervention group:

  1. Adults aged 18 to 55
  2. Have used drugs in the past 90 days
  3. At the time of case recruitment, the subject is engaged in an intimate relationship with a spouse/partner, or having a child/children
  4. Understand oral and written Chinese

Exclusion criteria for intervention group:

  1. Taking other treatments during intervention
  2. The spouse or child of DA are not available to participate in the program

Inclusion criteria for comparison group:

  1. Adults aged 18 to 55
  2. Have used drugs in the past 90 days
  3. Understand oral and written Chinese

Exclusion criteria for comparison group:

1. Taking other treatments during intervention

Sites / Locations

  • Neo-Horizon of Hong Kong Sheng Kung Hui Welfare Council LimitedRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

family-based intervention plus routine care

routine care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes from baseline measurements of frequency of drug use at 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.
Changes from baseline measurements of drug abstinence at 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.
Changes from baseline measurement of craving for drugs at 1-, 2-, and 4-months
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

Secondary Outcome Measures

Changes from baseline measurement of marital affection at 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.
Changes from baseline measurement of marital satisfaction at 1-, 2-, and 4-months
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.
Changes from baseline measurement of family functioning at 1-, 2-, and 4-months
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.
Changes from baseline measurement of family communication at 1-, 2-, and 4-months
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.
Changes from baseline measurement of family roles at 1-, 2-, and 4-months
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.
Changes from baseline measurement of parenting competency at 1-, 2-, and 4-months
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.
Changes from baseline measurement of mental health at 1-, 2-, and 4-months
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.
Changes from baseline measurement of Perception of Parenting Behaviors at 1-, 2-, and 4-months
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.
Changes from baseline measurement of co-dependency at 1-, 2-, and 4-months
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.

Full Information

First Posted
January 19, 2021
Last Updated
November 6, 2022
Sponsor
The University of Hong Kong
Collaborators
Hong Kong Sheng Kung Hui Welfare Council Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04725266
Brief Title
A Family-based Intervention for Drug-abusing Adults in Hong Kong
Official Title
A Family-based Intervention for Drug-abusing Adults in Hong Kong: A Quasi-experimental Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Hong Kong Sheng Kung Hui Welfare Council Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To develop a family-based intervention with components of engagement, family roles, affection, and competence and verify its effectiveness on drug abstinence and family functioning for drug-abusing adults in Hong Kong; To compare the difference between family-based intervention and routine care which mainly consists of individual counselling services for drug abusers.
Detailed Description
This is a quasi-experimental trial examining the effects of a proposed family-based intervention for drug abusers on motivating them to stay drug abstinence and improve family functioning, in which 40 drug abusers with focal families (including spouses and/or children) will be recruited for intervention group receiving both family-based intervention and routine care and 40 drug abusers without involving family will be recruited for comparison group receiving routine care. In the in-take, drug-abusing subjects will be given a brief introduction and invited to provide basic background information about themselves and families. After filling the informed consent, participants will be assigned to intervention group or comparison group according to whether their family will join sessions together. After drug abusers and families fill in the online questionnaire at the baseline (T0), the intervention group will receive family-based intervention and routine care in one month, while the comparison group will receive only routine care in one month. Both groups will be assessed at three follow-up time points (T1 = 1-month after baseline; T2 = 2-month after baseline; T3 = 4-month after baseline). As hypothesized, the intervention group will show a greater reduction in the primary outcomes of drug use and greater increase in the secondary outcomes of family functioning than the comparison group. A repeated-measures analysis of covariance will be conducted to assess the effects of family-based intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse
Keywords
drug abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
family-based intervention plus routine care
Arm Type
Experimental
Arm Description
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.
Arm Title
routine care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Family-based intervention
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
routine care
Intervention Description
Routine care includes individual-session components of engagement, case assessment, drug education, service referral, family support, and etc.
Primary Outcome Measure Information:
Title
Changes from baseline measurements of frequency of drug use at 1-, 2-, and 4-months
Description
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.
Time Frame
Baseline,1-, 2-, and 4-months
Title
Changes from baseline measurements of drug abstinence at 1-, 2-, and 4-months
Description
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.
Time Frame
Baseline,1-, 2-, and 4-months
Title
Changes from baseline measurement of craving for drugs at 1-, 2-, and 4-months
Description
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
Time Frame
Baseline,1-, 2-, and 4-months
Secondary Outcome Measure Information:
Title
Changes from baseline measurement of marital affection at 1-, 2-, and 4-months
Description
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.
Time Frame
Baseline,1-, 2-, and 4-months
Title
Changes from baseline measurement of marital satisfaction at 1-, 2-, and 4-months
Description
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.
Time Frame
Baseline,1-, 2-, and 4-months
Title
Changes from baseline measurement of family functioning at 1-, 2-, and 4-months
Description
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.
Time Frame
Baseline,1-, 2-, and 4-months
Title
Changes from baseline measurement of family communication at 1-, 2-, and 4-months
Description
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.
Time Frame
Baseline,1-, 2-, and 4-months
Title
Changes from baseline measurement of family roles at 1-, 2-, and 4-months
Description
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.
Time Frame
Baseline,1-, 2-, and 4-months
Title
Changes from baseline measurement of parenting competency at 1-, 2-, and 4-months
Description
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.
Time Frame
Baseline,1-, 2-, and 4-months
Title
Changes from baseline measurement of mental health at 1-, 2-, and 4-months
Description
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.
Time Frame
Baseline,1-, 2-, and 4-months
Title
Changes from baseline measurement of Perception of Parenting Behaviors at 1-, 2-, and 4-months
Description
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.
Time Frame
Baseline,1-, 2-, and 4-months
Title
Changes from baseline measurement of co-dependency at 1-, 2-, and 4-months
Description
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.
Time Frame
Baseline,1-, 2-, and 4-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yik Wa Law
Phone
+852-3917-5940
Email
flawhk@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yik Wa Law
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neo-Horizon of Hong Kong Sheng Kung Hui Welfare Council Limited
City
Kowloon
Country
Hong Kong
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Family-based Intervention for Drug-abusing Adults in Hong Kong

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