DepressionPhase 3NCT00360451
Effectiveness of School-Based Cognitive Behavioral Therapy in Preventing Depression in Young Adolescents
A Phase 3 study testing Adolescent only Penn Resiliency Program (Adolescent PRP) and Parent Penn Resiliency Program (Parent PRP) in people with Depression and Anxiety, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of the Penn Resiliency Program, a school-based cognitive behavioral depression prevention program for young adolescents. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Adolescent only Penn Resiliency Program (Adolescent PRP) and Parent Penn Resiliency Program (Parent PRP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Mar 2008
- Phase
- Phase 3
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Student with above average levels of depression and anxiety symptoms (students with average or below average symptoms will be enrolled into the study space permitting)
Who cannot join
- Not a student in a participating school
- Not a student in grades six through eight
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Preventing Depression in School Children
This study will evaluate the effectiveness of the Penn Resiliency Program, a school-based cognitive behavioral depression prevention program for young adolescents.
Read the detailed description
Depression is a serious illness that affects a person's mood, thoughts, and physical well-being. Research suggests that approximately one in five children meets criteria for a major depressive episode by the end of high school. These children are at increased risk for a wide range of social, psychological, physical, and achievement-related problems. Thus, the potential benefits of effective and highly transportable depression prevention programs are enormous. The Penn Resiliency Program (PRP) is a school-based group intervention that teaches cognitive behavioral and social problem-solving skills to young adolescents. This study will examine the effectiveness of PRP in preventing symptoms of depression and anxiety among a group of young adolescents.
Participants in this open label study will be randomly assigned to one of three groups: adolescent only PRP, adolescent plus parent PRP, or no treatment control. In adolescent PRP, students will be taught cognitive and behavioral problem solving skills by school counselors and teachers. Parents in PRP will be taught to model and reinforce the skills taught in the adolescent program. Participants in the adolescent program will attend twelve 90-minute group sessions after school hours. Participants in the parent program will attend six 90-minute group sessions. Adolescent participants will attend booster sessions twice per year for 2 to 3 years after the initial treatment has ended. Parents will attend one booster session per year during the follow-up phase. Adolescents' depression and anxiety symptoms will be assessed through questionnaires at baseline, post-treatment, and 6-month intervals for 2 to 3 years following the intervention. Adolescents will also complete questionnaires about their coping behaviors, feelings of hopelessness, and several other outcomes related to depression and anxiety in adolescence. Data will be collected once per year from parents and teachers. Adolescent participants will also be assessed for depression and anxiety disorders each year the child is in the study.
- Conditions
- Depression, Anxiety
- Being tested
- Adolescent only Penn Resiliency Program (Adolescent PRP), Parent Penn Resiliency Program (Parent PRP)
- Keywords
- Prevention, Child, Adolescent, Parent
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adolescent only Penn Resiliency Program (Adolescent PRP)Behavioural
In adolescent PRP, students learn both cognitive skills (recognizing the link between beliefs and emotions, challenging negative beliefs with evidence, making accurate attributions for events, and accurately assessing the ramifications of negative events) and behavioral problem-solving skills (decision making, assertiveness and negotiation, social skills, and relaxation).
Parent Penn Resiliency Program (Parent PRP)Behavioural
Parent PRP teaches parents to model and reinforce the skills taught in the adolescent program.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Adolescent only Penn Resiliency Program Receives: Behavioral: Adolescent only Penn Resiliency Program (Adolescent PRP) |
| 2 | Experimental | Adolescent plus parent Penn Resiliency Program Receives: Behavioral: Adolescent only Penn Resiliency Program (Adolescent PRP); Behavioral: Parent Penn Resiliency Program (Parent PRP) |
| 3 | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescents' depressive symptoms by self-report
Measured: Measured at baseline, post-treatment, and 6-month follow-ups
Adolescents' symptoms of anxiety by self-report
Measured: Measured at baseline, post-treatment, and 6-month follow-ups
Adolescents' symptoms of depression and anxiety, including clinical levels of symptoms, as assessed by diagnostic interview
Measured: Measured at baseline and 6, 18, and 30-month follow-ups
Secondary outcomes (5)
Adolescents' externalizing symptoms by teacher report
Measured: Measured at baseline and 6, 18, and 30-month follow-ups
Adolescents' attributional style by self-report
Measured: Measured at baseline and 6, 18, and 30-month follow-ups
Parental depression by self-report
Measured: Measured at baseline and 6, 18, and 30-month follow-ups
Parental anxiety by self-report
Measured: Measured at baseline and 6, 18, and 30-month follow-ups
Parental attributional style by self-report
Measured: Measured at baseline and 6, 18, and 30-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2006 (estimated)
- Study startSep 2002
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Martin E.P. Seligman, PhD, Principal investigator, Positive Psychology Center, University of PennsylvaniaJane E. Gillham, PhD, Study director, Swarthmore College & University of PennsylvaniaKaren J. Reivich, PhD, Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360451
- Sponsor's protocol ID
- R01 MH0522070
- Other IDs
- 5R01MH052270, DSIR CT-P
- Status last verified
- Aug 2008
- First submitted
- 2 Aug 2006
- Last updated
- 10 Sep 2015
- Results posted
- No
Publications
Gillham JE, Reivich KJ, Brunwasser SM, Freres DR, Chajon ND, Kash-Macdonald VM, Chaplin TM, Abenavoli RM, Matlin SL, Gallop RJ, Seligman ME. Evaluation of a group cognitive-behavioral depression prevention program for young adolescents: a randomized effectiveness trial. J Clin Child Adolesc Psychol. 2012;41(5):621-39. doi: 10.1080/15374416.2012.706517. Epub 2012 Aug 13.
PubMed 22889296
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Depression in School Children
- ClinicalTrials.gov ID
- NCT00360451
- Acronym / sponsor ID
- R01 MH0522070
- Conditions
- Depression, Anxiety
- Keywords
- Prevention, Child, Adolescent, Parent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2002
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 4 Aug 2006 (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.
This study will evaluate the effectiveness of the Penn Resiliency Program, a school-based cognitive behavioral depression prevention program for young adolescents.
Detailed description
Depression is a serious illness that affects a person's mood, thoughts, and physical well-being. Research suggests that approximately one in five children meets criteria for a major depressive episode by the end of high school. These children are at increased risk for a wide range of social, psychological, physical, and achievement-related problems. Thus, the potential benefits of effective and highly transportable depression prevention programs are enormous. The Penn Resiliency Program (PRP) is a school-based group intervention that teaches cognitive behavioral and social problem-solving skills to young adolescents. This study will examine the effectiveness of PRP in preventing symptoms of depression and anxiety among a group of young adolescents.
Participants in this open label study will be randomly assigned to one of three groups: adolescent only PRP, adolescent plus parent PRP, or no treatment control. In adolescent PRP, students will be taught cognitive and behavioral problem solving skills by school counselors and teachers. Parents in PRP will be taught to model and reinforce the skills taught in the adolescent program. Participants in the adolescent program will attend twelve 90-minute group sessions after school hours. Participants in the parent program will attend six 90-minute group sessions. Adolescent participants will attend booster sessions twice per year for 2 to 3 years after the initial treatment has ended. Parents will attend one booster session per year during the follow-up phase. Adolescents' depression and anxiety symptoms will be assessed through questionnaires at baseline, post-treatment, and 6-month intervals for 2 to 3 years following the intervention. Adolescents will also complete questionnaires about their coping behaviors, feelings of hopelessness, and several other outcomes related to depression and anxiety in adolescence. Data will be collected once per year from parents and teachers. Adolescent participants will also be assessed for depression and anxiety disorders each year the child is in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Adolescent only Penn Resiliency Program (Adolescent PRP)Adolescent only Penn Resiliency Program |
| 2 | Experimental | Behavioral: Adolescent only Penn Resiliency Program (Adolescent PRP), Behavioral: Parent Penn Resiliency Program (Parent PRP)Adolescent plus parent Penn Resiliency Program |
| 3 | No intervention | –Control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Student with above average levels of depression and anxiety symptoms (students with average or below average symptoms will be enrolled into the study space permitting)
Key exclusion criteria (2 listed)
- Not a student in a participating school
- Not a student in grades six through eight
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 |
|---|---|---|
| Adolescent only Penn Resiliency Program (Adolescent PRP)In adolescent PRP, students learn both cognitive skills (recognizing the link between beliefs and emotions, challenging negative beliefs with evidence, making accurate attributions for events, and accurately assessing the ramifications of negative events) and behavioral problem-solving skills (decision making, assertiveness and negotiation, social skills, and relaxation). | Behavioural | 1, 2 |
| Parent Penn Resiliency Program (Parent PRP)Parent PRP teaches parents to model and reinforce the skills taught in the adolescent program. | Behavioural | 2 |
Primary outcome
Adolescents' depressive symptoms by self-report
Time frame: Measured at baseline, post-treatment, and 6-month follow-ups
Adolescents' symptoms of anxiety by self-report
Time frame: Measured at baseline, post-treatment, and 6-month follow-ups
Adolescents' symptoms of depression and anxiety, including clinical levels of symptoms, as assessed by diagnostic interview
Time frame: Measured at baseline and 6, 18, and 30-month follow-ups
5 secondary outcomes
Adolescents' externalizing symptoms by teacher report
Time frame: Measured at baseline and 6, 18, and 30-month follow-ups
Adolescents' attributional style by self-report
Time frame: Measured at baseline and 6, 18, and 30-month follow-ups
Parental depression by self-report
Time frame: Measured at baseline and 6, 18, and 30-month follow-ups
Parental anxiety by self-report
Time frame: Measured at baseline and 6, 18, and 30-month follow-ups
Parental attributional style by self-report
Time frame: Measured at baseline and 6, 18, and 30-month follow-ups
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 10 Sep 2015.
- Derived from this study: PubMed 22889296Gillham JE, Reivich KJ, Brunwasser SM, Freres DR, Chajon ND, Kash-Macdonald VM, Chaplin TM, Abenavoli RM, Matlin SL, Gallop RJ, Seligman ME. Evaluation of a group cognitive-behavioral depression prevention program for young adolescents: a randomized effectiveness trial. J Clin Child Adolesc Psychol. 2012;41(5):621-39. doi: 10.1080/15374416.2012.706517. Epub 2012 Aug 13.
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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.
Martin E.P. Seligman, PhD principal investigator
Positive Psychology Center, University of Pennsylvania
Jane E. Gillham, PhD study director
Swarthmore College & University of Pennsylvania
Karen J. Reivich, PhD study director
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adolescent only Penn Resiliency Program (Adolescent PRP) and Parent Penn Resiliency Program (Parent PRP) in people with Depression and Anxiety, run by University of Pennsylvania at 1 site in United States.
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 10 Sep 2015. 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 United States. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Adolescents' depressive symptoms by self-report (time frame: Measured at baseline, post-treatment, and 6-month follow-ups). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00360451, which also lists 1 linked publication.
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 10 Sep 2015.