Community Adolescents at Risk for Depression and SuicideEarly Phase 1NCT00946413
Application and Evaluation of Group Cognitive Intervention for Depressed Adolescents
A Early Phase 1 study testing CBT plus parent education and CBT alone in people with Community Adolescents at Risk for Depression and Suicide, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial summary
Cognitive behavioral therapy (CBT) is effective and CBT with parental involvement has potential in preventing and treating adolescent depression. The purpose of this study was to compare the short- and long-term effectiveness of CBT alone and CBT plus parental education for community-based adolescents at risk for… Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Community Adolescents at Risk for Depression and Suicide
- What is being tested?
- CBT plus parent education and CBT alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2006to Dec 2007
- Phase
- Early Phase 1
- 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 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- willing to participate group assignment and grant consents
Who cannot join
- unwilling to participate potential group activity and grant consents
- severe physical or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Cognitive behavioral therapy (CBT) is effective and CBT with parental involvement has potential in preventing and treating adolescent depression. The purpose of this study was to compare the short- and long-term effectiveness of CBT alone and CBT plus parental education for community-based adolescents at risk for depression and suicide in Taiwan. It is hypothesized that the CBT alone and CBT with parental education group are more effective than the control group.
Read the detailed description
Cognitive behavioral therapy (CBT) is well known for its active, directive, time-limited, and structured approach. Despite an increasing prevalence of adolescent depression in Taiwan, few studies have been conducted to evaluate the immediate and long-term effectiveness of CBT for community-based adolescents at risk for depression and suicide. Also, little is known about the effectiveness of the involvement of parents in CBT groups. The Adolescent Coping with Depression Course (CWDA) (19) is an effective CBT-oriented group intervention for adolescent depression. However, it has not been tested in specific cultural groups. The primary purpose of this study was therefore to compare the immediate and long-term effectiveness of CBT alone, CBT with parental education, and control groups for community-based adolescents at risk for depression and suicide.A quasi-experimental research design was used in this study. Community-based high school students at risk for depression and suicide were recruited and assigned to one of two experimental groups or a control group. Students in the experimental groups received CBT plus parental education (group A, n = 9) or CBT alone (group B, n = 10). The control group was designed as a waiting list group (group C, n = 12). Both experimental groups received a follow-up session 1 year after the intervention. Several outcome variables (depressive symptoms, suicidal ideation, cognitive triad, learned resourcefulness [LR], and salivary cortisol level) were used to determine the effectiveness of treatment.
- Being tested
- CBT plus parent education, CBT alone
- Keywords
- CBT, Depressed and suicidal adolescents
- Medical subject headings
- Suicide, Color Vision Defects, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT plus parent educationBehavioural
The 10-session group CBT with two-session parental education in our study was derived from the CWDA, with some modifications made based on cultural considerations. Skills taught and discussed included mood monitoring, improving social skills, increasing pleasant activities, decreasing anxiety, reducing depressogenic cognitions, improving communication, and conflict resolution. The issues taught and discussed included an introduction to adolescent depression and suicide, their etiology, symptoms, treatment, and prognosis, as well as stress management. A 1-year individual follow-up program was used to maintain the effect of the experimental intervention and to provide necessary individual interventions for students such as CBT, support, and counseling.
CBT aloneBehavioural
The 10-session group CBT with two-session parental education in our study was derived from the CWDA, with some modifications made based on cultural considerations. Skills taught and discussed included mood monitoring, improving social skills, increasing pleasant activities, decreasing anxiety, reducing depressogenic cognitions, improving communication, and conflict resolution.A 1-year individual follow-up program was used to maintain the effect of the experimental intervention and to provide necessary individual interventions for students such as CBT, support, and counseling.
| Study group | Role | What they receive |
|---|---|---|
| CBT plus parent education | Experimental | Not described Receives: Behavioral: CBT plus parent education |
| CBT alone | Experimental | Not described Receives: Behavioral: CBT alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
depressive symptoms, suicidal ideation, cognitive triad, learned resourcefulness (LR), and salivary cortisol
Measured: 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startJan 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Adolescents at Risk for Depression and SuicideStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health
- Investigators
- Hsiu-Ju Chang, phD, Principal investigator, School of Nursing, Taipei Meidcal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946413
- Sponsor's protocol ID
- DOH95-TD-M-113-058
- Status last verified
- Jul 2009
- First submitted
- 24 Jul 2009
- Last updated
- 27 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application and Evaluation of Group Cognitive Intervention for Depressed Adolescents
- ClinicalTrials.gov ID
- NCT00946413
- Acronym / sponsor ID
- DOH95-TD-M-113-058
- Keywords
- CBT, Depressed and suicidal adolescents
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Collaborators
- Department of Health
- Study start
- Jan 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 27 Jul 2009 (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.
Cognitive behavioral therapy (CBT) is effective and CBT with parental involvement has potential in preventing and treating adolescent depression. The purpose of this study was to compare the short- and long-term effectiveness of CBT alone and CBT plus parental education for community-based adolescents at risk for depression and suicide in Taiwan. It is hypothesized that the CBT alone and CBT with parental education group are more effective than the control group.
Detailed description
Cognitive behavioral therapy (CBT) is well known for its active, directive, time-limited, and structured approach. Despite an increasing prevalence of adolescent depression in Taiwan, few studies have been conducted to evaluate the immediate and long-term effectiveness of CBT for community-based adolescents at risk for depression and suicide. Also, little is known about the effectiveness of the involvement of parents in CBT groups. The Adolescent Coping with Depression Course (CWDA) (19) is an effective CBT-oriented group intervention for adolescent depression. However, it has not been tested in specific cultural groups. The primary purpose of this study was therefore to compare the immediate and long-term effectiveness of CBT alone, CBT with parental education, and control groups for community-based adolescents at risk for depression and suicide.A quasi-experimental research design was used in this study. Community-based high school students at risk for depression and suicide were recruited and assigned to one of two experimental groups or a control group. Students in the experimental groups received CBT plus parental education (group A, n = 9) or CBT alone (group B, n = 10). The control group was designed as a waiting list group (group C, n = 12). Both experimental groups received a follow-up session 1 year after the intervention. Several outcome variables (depressive symptoms, suicidal ideation, cognitive triad, learned resourcefulness [LR], and salivary cortisol level) were used to determine the effectiveness of treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT plus parent education | Experimental | Behavioral: CBT plus parent education |
| CBT alone | Experimental | Behavioral: CBT alone |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- willing to participate group assignment and grant consents
Key exclusion criteria (2 listed)
- unwilling to participate potential group activity and grant consents
- severe physical or psychiatric disorders
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 |
|---|---|---|
| CBT plus parent educationThe 10-session group CBT with two-session parental education in our study was derived from the CWDA, with some modifications made based on cultural considerations. Skills taught and discussed included mood monitoring, improving social skills, increasing pleasant activities, decreasing anxiety, reducing depressogenic cognitions, improving communication, and conflict resolution. The issues taught and discussed included an introduction to adolescent depression and suicide, their etiology, symptoms, treatment, and prognosis, as well as stress management. A 1-year individual follow-up program was used to maintain the effect of the experimental intervention and to provide necessary individual interventions for students such as CBT, support, and counseling. | Behavioural | CBT plus parent education |
| CBT aloneThe 10-session group CBT with two-session parental education in our study was derived from the CWDA, with some modifications made based on cultural considerations. Skills taught and discussed included mood monitoring, improving social skills, increasing pleasant activities, decreasing anxiety, reducing depressogenic cognitions, improving communication, and conflict resolution.A 1-year individual follow-up program was used to maintain the effect of the experimental intervention and to provide necessary individual interventions for students such as CBT, support, and counseling. | Behavioural | CBT alone |
Primary outcome
depressive symptoms, suicidal ideation, cognitive triad, learned resourcefulness (LR), and salivary cortisol
Time frame: 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2009.
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.
Hsiu-Ju Chang, phD principal investigator
School of Nursing, Taipei Meidcal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CBT plus parent education and CBT alone in people with Community Adolescents at Risk for Depression and Suicide, run by Taipei Medical University 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 27 Jul 2009. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
depressive symptoms, suicidal ideation, cognitive triad, learned resourcefulness (LR), and salivary cortisol (time frame: 6). 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 27 Jul 2009.