NCT04725266

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

3.3 years

First QC Date

January 19, 2021

Last Update Submit

October 7, 2024

Conditions

Keywords

drug abuse

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline, 1-, and 2-months

Secondary Outcomes (5)

  • Changes from baseline measurement of marital affection at 1- and 2-months

    Baseline, 1- and 2-months

  • Changes from baseline measurement of family functioning at 1- and 2-months

    Baseline, 1- and 2-months

  • Changes from baseline measurement of family roles at 1- and 2-months

    Baseline, 1- and 2-months

  • Changes from baseline measurement of parenting competency at 1- and 2-months

    Baseline, 1- and 2-months

  • Changes from baseline measurement of mental health at 1- and 2-months

    Baseline, 1- and 2-months

Study Arms (2)

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.

Behavioral: Family-based interventionOther: 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.

Other: routine care

Interventions

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).

family-based intervention plus routine care

Routine care includes individual-session components of engagement, case assessment, drug education, service referral, family support, and etc.

family-based intervention plus routine careroutine care

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Taking other treatments during intervention
  • The spouse or child of DA are not available to participate in the program
  • Adults aged 18 to 55
  • Have used drugs in the past 90 days
  • Understand oral and written Chinese
  • \. Taking other treatments during intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Kowloon, Hong Kong

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Yik Wa Law

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 26, 2021

Study Start

September 1, 2019

Primary Completion

December 31, 2022

Study Completion

June 1, 2023

Last Updated

October 10, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations