NCT02933125

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 31, 2016

Status Verified

June 1, 2013

Enrollment Period

4 years

First QC Date

October 12, 2016

Last Update Submit

October 28, 2016

Conditions

Keywords

substance abusegroup psychotherapyfamily therapylongitudinal studychild and adolescent

Outcome Measures

Primary Outcomes (2)

  • Substance-use relapse

    Relapse is defined as positive urine test for any substance within the follow-up period.

    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.

    Longitudinal follow-up for 3 years

Study Arms (2)

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.

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.

Behavioral: Standard supervision

Interventions

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.

Intervention group

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.

Comparison group

Eligibility Criteria

Age12 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • The adolescents with illicit drug age between 12 to 20.
  • One of their parents can attend the counseling program.

You may not qualify if:

  • The adolescents or their parents can't attend the program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liang-Jen Wang

Kaohsiung City, Kaohsiung, Taiwan

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Liang-Jen Wang, MD, MPH

    Chang Gung Memorial Hospital, Kaohsiung, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang-Jen Wang, MD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 14, 2016

Study Start

July 1, 2013

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

October 31, 2016

Record last verified: 2013-06

Data Sharing

IPD Sharing
Will not share

Locations