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

• ClinicalTrials.gov Identifier: NCT04725266
• Recruitment Status: Recruiting
• First Posted: January 26, 2021
• Last Update Posted: January 26, 2021
• Sponsor: The University of Hong Kong
• Collaborator: Hong Kong Sheng Kung Hui Welfare Council Limited
• Information provided by (Responsible Party): Dr.Yik-Wa Law, The University of Hong Kong

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.

Condition or disease	Intervention/treatment	Phase
Drug Abuse	Behavioral: Family-based intervention; Other: routine care	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Family-based Intervention for Drug-abusing Adults in Hong Kong: A Quasi-experimental Trial
• Actual Study Start Date: September 1, 2019
• Estimated Primary Completion Date: July 1, 2022
• Estimated Study Completion Date: September 1, 2022

Arms and Interventions

Arm	Intervention/treatment
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.	Behavioral: Family-based intervention; 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).; Other: routine care; Routine care includes individual-session components of engagement, case assessment, drug education, service referral, family support, and etc.
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.	Other: routine care; Routine care includes individual-session components of engagement, case assessment, drug education, service referral, family support, and etc.

Outcome Measures

Primary Outcome Measures :

1. 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.

2. 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.

3. Changes from baseline measurement of craving for drugs at 1-, 2-, and 4-months [ Time Frame: Baseline,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 :

1. 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.

2. Changes from baseline measurement of marital satisfaction at 1-, 2-, and 4-months [ Time Frame: Baseline,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.

3. Changes from baseline measurement of family functioning at 1-, 2-, and 4-months [ Time Frame: Baseline,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.

4. Changes from baseline measurement of family communication at 1-, 2-, and 4-months [ Time Frame: Baseline,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.

5. Changes from baseline measurement of family roles at 1-, 2-, and 4-months [ Time Frame: Baseline,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.

6. Changes from baseline measurement of parenting competency at 1-, 2-, and 4-months [ Time Frame: Baseline,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.

7. Changes from baseline measurement of mental health at 1-, 2-, and 4-months [ Time Frame: Baseline,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.

8. Changes from baseline measurement of Perception of Parenting Behaviors at 1-, 2-, and 4-months [ Time Frame: Baseline,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.

9. Changes from baseline measurement of co-dependency at 1-, 2-, and 4-months [ Time Frame: Baseline,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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Yik Wa Law; +852-3917-5940; flawhk@hku.hk

Locations

Hong Kong

Neo-Horizon of Hong Kong Sheng Kung Hui Welfare Council Limited; Recruiting

Kowloon, Hong Kong

Sponsors and Collaborators

The University of Hong Kong

Hong Kong Sheng Kung Hui Welfare Council Limited

Investigators

• Principal Investigator: Yik Wa Law; The University of Hong Kong

More Information

• Responsible Party: Dr.Yik-Wa Law, Associate Professor, The University of Hong Kong
• ClinicalTrials.gov Identifier: NCT04725266
• Other Study ID Numbers: 200018
• First Posted: January 26, 2021
• Last Update Posted: January 26, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr.Yik-Wa Law, The University of Hong Kong:

drug abuse

Additional relevant MeSH terms:

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders