Drug AbuseNCT04725266
A Family-based Intervention for Drug-abusing Adults in Hong Kong
A study testing Family-based intervention and routine care in people with Drug Abuse, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Drug Abuse
- What is being tested?
- Family-based intervention and routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2019to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
- Adults aged 18 to 55
- Have used drugs in the past 90 days
- Understand oral and written Chinese
Who cannot join
- Taking other treatments during intervention
- The spouse or child of DA are not available to participate in the program
- 1. Taking other treatments during intervention
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Neo-Horizon of Hong Kong Sheng Kung Hui Welfare Council Limited
Kowloon
About this study
Official title: A Family-based Intervention for Drug-abusing Adults in Hong Kong: a Quasi-experimental Trial
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.
Read the 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 two time points after intervention period (T1 = 1-month after baseline; T2 = 2-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.
- Conditions
- Drug Abuse
- Being tested
- Family-based intervention, routine care
- Keywords
- drug abuse
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based interventionBehavioural
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 17 sessions will be delivered with 1.5-2 hour for each session (6 sessions for Engagement, 3 sessions for Role identification, 3 sessions for Affection, and 3 sessions for Competence).
routine careOther
Routine care includes individual-session components of engagement, case assessment, drug education, service referral, family support, and etc.
| Study group | Role | What they receive |
|---|---|---|
| family-based intervention plus routine care | Experimental | 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. Receives: Behavioral: Family-based intervention; Other: routine care |
| routine care | Active comparator | 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. Receives: Other: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline measurements of drug abstinenceat at 1- and 2-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.
Measured: Baseline, 1- and 2-months
Changes from baseline measurements of frequency of drug use at 1- and 2-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.
Measured: Baseline, 1-, and 2-months
Secondary outcomes (5)
Changes from baseline measurement of marital affection at 1- and 2-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.
Measured: Baseline, 1- and 2-months
Changes from baseline measurement of family functioning at 1- and 2-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.
Measured: Baseline, 1- and 2-months
Changes from baseline measurement of family roles at 1- and 2-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.
Measured: Baseline, 1- and 2-months
Changes from baseline measurement of parenting competency at 1- and 2-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.
Measured: Baseline, 1- and 2-months
Changes from baseline measurement of mental health at 1- and 2-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.
Measured: Baseline, 1- and 2-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Sep 2019
- Primary completion31 Dec 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AbuseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Sheng Kung Hui Welfare Council Limited
- Responsible party
- Principal investigator, Dr.Yik-Wa Law, The University of Hong Kong
- Investigators
- Yik Wa Law, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725266
- Sponsor's protocol ID
- 200018
- Status last verified
- Oct 2024
- First submitted
- 19 Jan 2021
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Family-based Intervention for Drug-abusing Adults in Hong Kong: a Quasi-experimental Trial
- ClinicalTrials.gov ID
- NCT04725266
- Acronym / sponsor ID
- 200018
- Conditions
- Drug Abuse
- Keywords
- drug abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Kong Sheng Kung Hui Welfare Council Limited
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 two time points after intervention period (T1 = 1-month after baseline; T2 = 2-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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| family-based intervention plus routine care | Experimental | Behavioral: Family-based intervention, Other: routine careThis 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. |
| routine care | Active comparator | Other: routine careThe group of participants will receive routine care which is widely used in social service providers and mainly includes individual counselling service for drug abusers. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
- Adults aged 18 to 55
Key exclusion criteria (3 listed)
- Taking other treatments during intervention
- The spouse or child of DA are not available to participate in the program
- 1. Taking other treatments during intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-based interventionThe 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 17 sessions will be delivered with 1.5-2 hour for each session (6 sessions for Engagement, 3 sessions for Role identification, 3 sessions for Affection, and 3 sessions for Competence). | Behavioural | family-based intervention plus routine care |
| routine careRoutine care includes individual-session components of engagement, case assessment, drug education, service referral, family support, and etc. | Other | family-based intervention plus routine care, routine care |
Primary outcome
Changes from baseline measurements of drug abstinenceat at 1- and 2-months
Time frame: Baseline, 1- and 2-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 measurements of frequency of drug use at 1- and 2-months
Time frame: Baseline, 1-, and 2-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.
5 secondary outcomes
Changes from baseline measurement of marital affection at 1- and 2-months
Time frame: Baseline, 1- and 2-months
Changes from baseline measurement of family functioning at 1- and 2-months
Time frame: Baseline, 1- and 2-months
Changes from baseline measurement of family roles at 1- and 2-months
Time frame: Baseline, 1- and 2-months
Changes from baseline measurement of parenting competency at 1- and 2-months
Time frame: Baseline, 1- and 2-months
Changes from baseline measurement of mental health at 1- and 2-months
Time frame: Baseline, 1- and 2-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yik Wa Law principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-based intervention and routine care in people with Drug Abuse, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline measurements of drug abstinenceat at 1- and 2-months (time frame: Baseline, 1- and 2-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.