Substance AbuseNCT02933125
Group Psychotherapy for Adolescents With Substance Use
A study testing Group psychotherapy and Standard supervision in people with Substance Abuse, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Background: Substance abuse among children and adolescents is an important public health issue in Taiwan. Kaoshiung Chang Gung Memorial Hospital and Taiwan Kaoshiung Juvenile and Family Court will cooperate in a counseling program for adolescents with illicit drug abusers in 2013, to perform a mandatory 10-week… Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Group psychotherapy and Standard supervision
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2013to Jul 2017
- 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 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The adolescents with illicit drug age between 12 to 20.
- One of their parents can attend the counseling program.
Who cannot join
- The adolescents or their parents can't attend the program.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Liang-Jen Wang
Kaohsiung City, Kaohsiung
Liang-Jen Wang, MD, MPH, 886-7-7317123 ext. 6319, wangliangjen@gmail.com
About this study
Official title: Effectiveness of Family-based Group Psychotherapy for Adolescents With Illicit Drug Use
Background: Substance abuse among children and adolescents is an important public health issue in Taiwan. Kaoshiung Chang Gung Memorial Hospital and Taiwan Kaoshiung Juvenile and Family Court will cooperate in a counseling program for adolescents with illicit drug abusers in 2013, to perform a mandatory 10-week family-based group psychotherapy.
Aims: This study aims (1) to investigate the effectiveness of the family-based group psychotherapy for adolescents with illicit drug abusers and their parents; (2) to identify whether the counseling program is effective for preventing the adolescents from relapse of substance abuse.
Expected Results: The investigators expect that (1) group psychotherapy may involve comprehensive benefits for adolescents with illicit drug abusers, by improving the changes in adolescents' substance-craving symptoms and behavioral problems, and reducing stress of their parents; (2) this counseling program is effective for preventing the adolescents from relapse of substance abuse; (3) the findings in this study will not only demonstrate empirical evidence of treatment effectiveness for adolescents with illicit drug abuse, but will also provide useful clues for future implementation of policy making.
Read the detailed description
- The investigators plan to recruit 200 adolescents (=< 20 years) with illicit drug abusers and their parents (100 of intervention group and 100 of comparison group).
- The intervention group consists of youths that participate in a program that combines a weekly 10-session out-patient motivational enhancement psychotherapy (MEP) program for youths with an additional weekly 10-session parenting skill training (PST) program for their guardians.
- The comparison group consists of youths that receive standard supervision by the court. All participants were followed up for a maximum of three years.
- The assessments for adolescents and their parents will be taken at pre- and post-treatment, using the Adolescents' Behavior-problem Scale, the Craving Beliefs Questionnaire, the Family APGAR, the Parenting Stress Index-Short From (PSI/SF) and the Chinese Health Questionnaire (CHQ).
- The information of adolescents' relapse of substance abuse will be collected by Kaoshiung Juvenile and Family Court.
- Conditions
- Substance Abuse
- Being tested
- Group psychotherapy, Standard supervision
- Keywords
- substance abuse, group psychotherapy, family therapy, longitudinal study, child and adolescent
- 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.
Group psychotherapyBehavioural
Motivational enhancement psychotherapy (MEP) for Youths:
The participating youths have to attend one session a week for 10 weeks of a group program for relapse prevention based on motivational enhancement ideas and led by two experienced psychologists from the hospital.
Parenting skill training (PST) for Caregivers:
The PST program for the youths' caregivers also consist of 10 weekly, 120-minute sessions that were led by a senior consulting psychologist.
Standard supervisionBehavioural
The standard supervision by the protection officers in Taiwan's Kaohsiung Juvenile and Family Court provide the adolescents with moral education, as well as counseling in their work or studies.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The youths in the intervention group will participate in a weekly 10-session out-patient motivational enhancement psychotherapy (MEP) program. In addition to this, these youths' caregivers will be referred to simultaneously take part in a weekly 10-session out-patient parenting skill training (PST) program at Kaohsiung Chang Gung Memorial Hospital. Receives: Behavioral: Group psychotherapy |
| Comparison group | Active comparator | The comparison group consists of substance-using adolescents that receive only standard supervision by the protection officers in Taiwan's Kaohsiung Juvenile and Family Court. The protection officers provide the adolescents with moral education, as well as counseling in their work or studies. Receives: Behavioral: Standard supervision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance-use relapse
Relapse is defined as positive urine test for any substance within the follow-up period.
Measured: Longitudinal follow-up for 3 years
Academic or social status
The academic or social outcome is categorized into as attending school, being employed, or being a dropout/unemployed.
Measured: Longitudinal follow-up for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startJul 2013
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liang-Jen Wang, MD, MPH, Principal investigator, Chang Gung Memorial Hospital, Kaohsiung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933125
- Sponsor's protocol ID
- 104-1729C
- Status last verified
- Jun 2013
- First submitted
- 12 Oct 2016
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Family-based Group Psychotherapy for Adolescents With Illicit Drug Use
- ClinicalTrials.gov ID
- NCT02933125
- Acronym / sponsor ID
- 104-1729C
- Conditions
- Substance Abuse
- Keywords
- substance abuse, group psychotherapy, family therapy, longitudinal study, child and adolescent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 14 Oct 2016 (estimated)
- 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.
Background: Substance abuse among children and adolescents is an important public health issue in Taiwan. Kaoshiung Chang Gung Memorial Hospital and Taiwan Kaoshiung Juvenile and Family Court will cooperate in a counseling program for adolescents with illicit drug abusers in 2013, to perform a mandatory 10-week family-based group psychotherapy.
Aims: This study aims (1) to investigate the effectiveness of the family-based group psychotherapy for adolescents with illicit drug abusers and their parents; (2) to identify whether the counseling program is effective for preventing the adolescents from relapse of substance abuse.
Expected Results: The investigators expect that (1) group psychotherapy may involve comprehensive benefits for adolescents with illicit drug abusers, by improving the changes in adolescents' substance-craving symptoms and behavioral problems, and reducing stress of their parents; (2) this counseling program is effective for preventing the adolescents from relapse of substance abuse; (3) the findings in this study will not only demonstrate empirical evidence of treatment effectiveness for adolescents with illicit drug abuse, but will also provide useful clues for future implementation of policy making.
Detailed description
- The investigators plan to recruit 200 adolescents (=< 20 years) with illicit drug abusers and their parents (100 of intervention group and 100 of comparison group).
- The intervention group consists of youths that participate in a program that combines a weekly 10-session out-patient motivational enhancement psychotherapy (MEP) program for youths with an additional weekly 10-session parenting skill training (PST) program for their guardians.
- The comparison group consists of youths that receive standard supervision by the court. All participants were followed up for a maximum of three years.
- The assessments for adolescents and their parents will be taken at pre- and post-treatment, using the Adolescents' Behavior-problem Scale, the Craving Beliefs Questionnaire, the Family APGAR, the Parenting Stress Index-Short From (PSI/SF) and the Chinese Health Questionnaire (CHQ).
- The information of adolescents' relapse of substance abuse will be collected by Kaoshiung Juvenile and Family Court.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Group psychotherapyThe youths in the intervention group will participate in a weekly 10-session out-patient motivational enhancement psychotherapy (MEP) program. In addition to this, these youths' caregivers will be referred to simultaneously take part in a weekly 10-session out-patient parenting skill training (PST) program at Kaohsiung Chang Gung Memorial Hospital. |
| Comparison group | Active comparator | Behavioral: Standard supervisionThe comparison group consists of substance-using adolescents that receive only standard supervision by the protection officers in Taiwan's Kaohsiung Juvenile and Family Court. The protection officers provide the adolescents with moral education, as well as counseling in their work or studies. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- The adolescents with illicit drug age between 12 to 20.
- One of their parents can attend the counseling program.
Key exclusion criteria (1 listed)
- The adolescents or their parents can't attend the program.
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 |
|---|---|---|
| Group psychotherapyMotivational enhancement psychotherapy (MEP) for Youths: The participating youths have to attend one session a week for 10 weeks of a group program for relapse prevention based on motivational enhancement ideas and led by two experienced psychologists from the hospital. Parenting skill training (PST) for Caregivers: The PST program for the youths' caregivers also consist of 10 weekly, 120-minute sessions that were led by a senior consulting psychologist. | Behavioural | Intervention group |
| Standard supervisionThe standard supervision by the protection officers in Taiwan's Kaohsiung Juvenile and Family Court provide the adolescents with moral education, as well as counseling in their work or studies. | Behavioural | Comparison group |
Primary outcome
Substance-use relapse
Time frame: Longitudinal follow-up for 3 years
Relapse is defined as positive urine test for any substance within the follow-up period.
Academic or social status
Time frame: Longitudinal follow-up for 3 years
The academic or social outcome is categorized into as attending school, being employed, or being a dropout/unemployed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- 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.
Liang-Jen Wang, MD, MPH principal investigator
Chang Gung Memorial Hospital, Kaohsiung, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group psychotherapy and Standard supervision in people with Substance Abuse, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 Oct 2016. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shing-Fang Lu (886-7-7317123 ext. 8995, luhsingfang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance-use relapse (time frame: Longitudinal follow-up for 3 years). 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 31 Oct 2016.