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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02933125
Other study ID # 104-1729C
Secondary ID
Status Recruiting
Phase N/A
First received October 12, 2016
Last updated October 28, 2016
Start date July 2013
Est. completion date July 2017

Study information

Verified date June 2013
Source Chang Gung Memorial Hospital
Contact Shing-Fang Lu
Phone 886-7-7317123
Email luhsingfang@gmail.com
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical 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 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.


Description:

1. 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).

2. 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.

3. The comparison group consists of youths that receive standard supervision by the court. All participants were followed up for a maximum of three years.

4. 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).

5. The information of adolescents' relapse of substance abuse will be collected by Kaoshiung Juvenile and Family Court.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 20 Years
Eligibility Inclusion Criteria:

- The adolescents with illicit drug age between 12 to 20.

- One of their parents can attend the counseling program.

Exclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Group psychotherapy
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 supervision
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.

Locations

Country Name City State
Taiwan Liang-Jen Wang Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Substance-use relapse Relapse is defined as positive urine test for any substance within the follow-up period. Longitudinal follow-up for 3 years No
Primary 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 No
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