Adapted and Translated, Adolescent Depression, Internet Intervention

Adolescent - Emotional Problem Clinical Trial

Official title:

Adaptation of a U.S. Internet Tool to Prevent Depression and Addiction in Hong Kong Adolescents

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01783652
• Other study ID #: catch_it_2013
• Status: Active, not recruiting
• Phase: N/A
• First received: January 31, 2013
• Last updated: July 10, 2014
• Start date: January 2013
• Est. completion date: July 2015

Study information

• Verified date: July 2014
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Objectives :

The key objective of this study is to develop new interventions that addresses the diverse needs and circumstances of Hong Kong adolescents with depressive symptoms in community settings. Collaboration between medical professionals and social workers may prevent the occurrence of depression and misguided attempts to self-treat with alcohol and / or drugs in our adolescents.

Methods :

To address this intervention gap in the United States, Dr. Van Voorhees, a research collaborator of Dr. Chim and Dr. Ip, developed and conducted a phase 2 clinical trial of a primary care internet-based depression prevention intervention (CATCH-IT, Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal training). It has been observed clinically that the strategy could reduce depressed mood, increased social support and reduced depressive episodes at 12 month follow-up.

The investigators now propose to study if an adaptation of the CATCH-IT website for Hong Kong Chinese adolescents may lead to significant reductions in depressed mood. In this pilot trial, the investigators propose to test the efficacy of the Adapted and Translated version of CATCH-IT (AT-CATCH) against the placebo approach in preventing the onset of depressive episodes in a group of adolescents (aged 13-17) who have depressive symptoms, but have not developed depression yet.The case group will have access to the AT-CATCH website while the control group will only be allow to use the anti-smoking website.

The investigators hypothesize that compared to youth in the control group, youth assigned to the AT-CATCH group will have a lower hazard ratio of major depressive episodes and decreased alcohol / drug use frequency over 2 years. Moreover, compared to youth in the control group, youth in the AT-CATCH program will demonstrate a steeper slope of improved symptoms through growth curve analysis and fewer depressed days over the study period.

Description:

Although efficacious psychological and pharmacological treatments for adolescent depression have been demonstrated, any single approach only helps about 50-75% of those treated. Furthermore, adolescents have low rates of care seeking, and many primary care patients find group therapy to be the least acceptable treatment for depression. Limited supply of mental health specialists make face-to-face counseling difficult to implement, hence the internet is a promising modality for the delivery of preventive interventions. Therefore, prevention of depression in at-risk adolescents may be more cost-effective and less distressing than allowing for the depressive symptoms to become more severe.

Key issues - international level:

As proposed by the World Health Organization (WHO) and National Institute of Mental Health (NIMH), prevention of mental disorders has become a major health need (9), and a primary care internet-based depression prevention intervention strategy should be developed. Such care has already been provided for depression in the U.S. by Dr. Van Voorhees, suggesting the intervention must:

1. have broad reach into at-risk populations;

2. work outside of traditional mental health systems;

3. use new technologies;

4. build on previous clinical trials;

5. reduce identified disorders/enhance functional outcomes;

6. include families; and

7. be personalized

Key issues - local level Developing new interventions that incorporate the diverse needs and circumstances of Hong Kong adolescents with depressive symptoms in community settings is our key strategic objective. While it is ideal to have a series of primary care physician consultations for at-risk adolescents, this is not available and too expensive for the lower socioeconomic class. This lack is apparent in both the East and the West. The U.S. has built up a new cost-effective prevention strategy for depression in primary care system; however, such a strategy may not be able to be incorporated into the public health sector. Hence, the collaboration between physicians and social workers will be used for this study.

Inclusion criteria:

138 adolescent participants (ages 13 to 21) who experience a moderately elevated level of depressive symptoms on the CES-D scale (score 16-34) will be recruited to join the study. Participants may or may not have had a past history of depression, anxiety and/or substance abuse.

Outcome measures to compare between 2 groups:

i) depressive episodes and symptoms Assessment of adolescent depression by the Centre of Epidemiological Studies Depression Scale (CES-D) and Depression Anxiety Stress Scale (DASS) are a standard diagnostic test for assessment of adolescent's depression. The scores of both groups would be measured and compared in 3 follow-ups to study the effect and its sustainability of the website intervention.

ii) use of alcohol and drugs Assessment of drinking and drug use behavior of adolescents by CRAFFT Screening Test, which includes questions regarding alcohol and drug use situations in the past 12 months, and additional assessment for those who show a significant problem. There are 6 questions covering road safety, drug-use habits, and influences of using drugs or alcohol.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 138
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 21 Years

Eligibility

Inclusion Criteria:

• age 13 to 21

• experience a moderately elevated level of depressive symptoms on the CES-D scale (score 16-34)

• may or may not have had a past history of depression, anxiety and/or substance abuse

Exclusion Criteria:

• currently diagnosed with depression, schizophrenia, or bipolar affective disorder ;

• currently taking antidepressants or psychotropic medication ;

• CES-D score equal or higher than 35, or a proved serious medical illness that causes significant disability or dysfunction ;

• exhibit significant reading impairment, mental retardation, developmental disabilities

• serious imminent suicidal risk or other conditions that may require immediate psychiatric hospitalization

• have extreme, current drug / alcohol abuse (greater than or equal to 2 on the CRAFFT)

Study Design

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

Related Conditions & MeSH terms

• Adolescent - Emotional Problem

Intervention

Behavioral:
• Intervention group
Participants in the intervention group will have access to the anti-depression website modified and translated by the University of Hong Kong. 10 chapters on understanding depression, identifying depression symptoms and techniques tackling depression will be covered. Exercises and built-in questionnaires on measuring emotions will be provided in the website. Additional telephone follow-up counseling at the third, sixth and twelfth months will be conducted.

Locations

Country	Name	City	State
China	The University of Hong Kong	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression symptoms	Centre for Epidemiological Studies Depression Scale (CES-D) : at baseline, 3 months, 6 months and 12 months	12 months	No
Secondary	Depression measurement	Depression Anxiety Stress Scale (DASS) : at baseline, 3 months, 6 months and 12 months	12 months	No
Secondary	alcohol abuse	CRAFFT Screening Test : at baseline, 3 months, 6 months, and 12 months	12 months	No