Adolescent - Emotional ProblemNCT01783652
Adapted and Translated, Adolescent Depression, Internet Intervention
A study testing Intervention group in people with Adolescent - Emotional Problem, run by The University of Hong Kong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 13 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent - Emotional Problem
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Jul 2015
- 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 13 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation of a U.S. Internet Tool to Prevent Depression and Addiction in Hong Kong Adolescents
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.
Read more
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.
Read the detailed 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:
- have broad reach into at-risk populations;
- work outside of traditional mental health systems;
- use new technologies;
- build on previous clinical trials;
- reduce identified disorders/enhance functional outcomes;
- include families; and
- 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:
- 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.
- Conditions
- Adolescent - Emotional Problem
- Being tested
- Intervention group
- Keywords
- Adolescent depression, internet intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Study participants in the intervention group will be given access to an anti-depression website and have four telephone follow-up within the 1-year study period. Receives: Behavioral: Intervention group |
| Control group | No intervention | Study participants in the control group will not received any depression-related service other than an interactive anti-smoking website provided by the University of Hong Kong. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptoms
Centre for Epidemiological Studies Depression Scale (CES-D) : at baseline, 3 months, 6 months and 12 months
Measured: 12 months
Secondary outcomes (2)
Depression measurement
Depression Anxiety Stress Scale (DASS) : at baseline, 3 months, 6 months and 12 months
Measured: 12 months
alcohol abuse
CRAFFT Screening Test : at baseline, 3 months, 6 months, and 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent - Emotional ProblemStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Chim, Dr., Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783652
- Sponsor's protocol ID
- catch_it_2013
- Status last verified
- Jul 2014
- First submitted
- 31 Jan 2013
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of a U.S. Internet Tool to Prevent Depression and Addiction in Hong Kong Adolescents
- ClinicalTrials.gov ID
- NCT01783652
- Acronym / sponsor ID
- catch_it_2013
- Conditions
- Adolescent - Emotional Problem
- Keywords
- Adolescent depression, internet intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 5 Feb 2013 (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.
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.
Detailed 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:
- have broad reach into at-risk populations;
- work outside of traditional mental health systems;
- use new technologies;
- build on previous clinical trials;
- reduce identified disorders/enhance functional outcomes;
- include families; and
- 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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention groupStudy participants in the intervention group will be given access to an anti-depression website and have four telephone follow-up within the 1-year study period. |
| Control group | No intervention | –Study participants in the control group will not received any depression-related service other than an interactive anti-smoking website provided by the University of Hong Kong. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Intervention groupParticipants 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. | Behavioural | Intervention group |
Primary outcome
Depression symptoms
Time frame: 12 months
Centre for Epidemiological Studies Depression Scale (CES-D) : at baseline, 3 months, 6 months and 12 months
2 secondary outcomes
Depression measurement
Time frame: 12 months
alcohol abuse
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
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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.
David Chim, Dr. principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Adolescent - Emotional Problem, run by The University of Hong Kong at 1 site in China.
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 3 inclusion and 6 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 11 Jul 2014. 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 China. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression symptoms (time frame: 12 months). 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 11 Jul 2014.