DepressionPhase 1R4PowerNCT00641368
R4Power: An Online Resilience Program for Adolescents
A Phase 1 study testing R4Power Program in people with Depression and Anxiety, run by Swarthmore College at 1 site in United States.
Trial summary
The study will evaluate the R4Power program, an online intervention designed to teach adolescents coping and problem-solving skills. Read more about this study
- Who is it for?
- Ages 11 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- R4Power Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Oct 2009
- Phase
- 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 11 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6th-8th grade students attending participating school OR adolescents aged 11-15 living in greater Philadelphia area
- Access to high speed internet connection (at home, school, or another location)
Who cannot join
- Below 6th grade reading level, as reported by parents
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Swarthmore College
Swarthmore, Pennsylvania, 19081
Jane E. Gillham, Ph.D., 610-957-6010, info@positivepsych.org
Jane E. Gillham, Ph.D.
About this study
The study will evaluate the R4Power program, an online intervention designed to teach adolescents coping and problem-solving skills.
Read the detailed description
This study examines the feasibility of a 10-lesson web-based intervention, the R4Power program, and its effectiveness in preventing symptoms of depression and anxiety. The R4Power Program teaches cognitive and problem-solving skills covered in classroom based interventions, including the Penn Resiliency Program, that have been found to reduce or prevent symptoms of depression in children and adolescents. This study examines whether adolescents can benefit from learning these skills through a computer (rather than classroom) intervention.
Adolescents in grades 6 through 8 who participate in this study will be assigned to one of two conditions: an intervention group that will complete the R4Power program during the first year (R4Power1), or a waitlist control group that will complete the R4Power program the following year (R4Power2). Students will complete the 10-lesson program over the course of twelve weeks. They will learn and practice cognitive skills (recognizing the link between their thoughts and feelings, identifying thinking traps, challenging their negative beliefs) and problem-solving skills (assertiveness, relaxation and distraction, overcoming procrastination, and decision making). Adolescents who participate in this study will be followed for one year, and their coping responses and symptoms of depression and anxiety will be assessed at four points: at the beginning of the study (baseline) and at follow-up assessments approximately 4, 12 and 16 months after baseline.
- Conditions
- Depression, Anxiety
- Being tested
- R4Power Program, Waitlist Control
- Keywords
- Adolescent, Child, Computer, Depression, Resilience
- 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.
R4Power ProgramBehavioural
Also called R4Power1
In the 10-lesson online R4Power Program, adolescents will learn cognitive skills (link between thoughts, feelings, and behaviors; thinking traps; challenging negative beliefs) and problem-solving skills (assertiveness; relaxation and distraction; overcoming procrastination; decision-making) in order to cope with stressful situations.
Waitlist ControlOther
Also called R4Power2
Adolescents in the waitlist control group will complete the R4Power program during the second year of the study.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | R4Power Program Receives: Behavioral: R4Power Program |
| 2 | Other | Waitlist Control Receives: Other: Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescents' coping strategies by self-report
Measured: Measured at baseline and follow-ups approximately 4, 12, and 16 months after baseline
Adolescents' depressive symptoms by self-report
Measured: Measured at baseline and follow-ups approximately 4, 12, and 16 months after baseline
Secondary outcomes (1)
Adolescents' symptoms of anxiety by self-report
Measured: Measured at baseline and follow-ups approximately 4, 12, and 16 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startOct 2007
- Primary completionOct 2009 (estimated)
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swarthmore College
- Sponsor type
- University, hospital or other
- Investigators
- Jane E. Gillham, Ph.D., Principal investigator, Swarthmore College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641368
- Sponsor's protocol ID
- 07-08-003
- Acronym
- R4Power
- Status last verified
- Mar 2008
- First submitted
- 17 Mar 2008
- Last updated
- 24 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- R4Power: An Online Resilience Program for Adolescents
- ClinicalTrials.gov ID
- NCT00641368
- Acronym / sponsor ID
- R4Power / 07-08-003
- Conditions
- Depression, Anxiety
- Keywords
- Adolescent, Child, Computer, Depression, Resilience
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Swarthmore CollegeUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 24 Mar 2008 (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.
The study will evaluate the R4Power program, an online intervention designed to teach adolescents coping and problem-solving skills.
Detailed description
This study examines the feasibility of a 10-lesson web-based intervention, the R4Power program, and its effectiveness in preventing symptoms of depression and anxiety. The R4Power Program teaches cognitive and problem-solving skills covered in classroom based interventions, including the Penn Resiliency Program, that have been found to reduce or prevent symptoms of depression in children and adolescents. This study examines whether adolescents can benefit from learning these skills through a computer (rather than classroom) intervention.
Adolescents in grades 6 through 8 who participate in this study will be assigned to one of two conditions: an intervention group that will complete the R4Power program during the first year (R4Power1), or a waitlist control group that will complete the R4Power program the following year (R4Power2). Students will complete the 10-lesson program over the course of twelve weeks. They will learn and practice cognitive skills (recognizing the link between their thoughts and feelings, identifying thinking traps, challenging their negative beliefs) and problem-solving skills (assertiveness, relaxation and distraction, overcoming procrastination, and decision making). Adolescents who participate in this study will be followed for one year, and their coping responses and symptoms of depression and anxiety will be assessed at four points: at the beginning of the study (baseline) and at follow-up assessments approximately 4, 12 and 16 months after baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: R4Power ProgramR4Power Program |
| 2 | Other | Other: Waitlist ControlWaitlist Control |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 6th-8th grade students attending participating school OR adolescents aged 11-15 living in greater Philadelphia area
- Access to high speed internet connection (at home, school, or another location)
Key exclusion criteria (1 listed)
- Below 6th grade reading level, as reported by parents
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 |
|---|---|---|
| R4Power ProgramAlso: R4Power1In the 10-lesson online R4Power Program, adolescents will learn cognitive skills (link between thoughts, feelings, and behaviors; thinking traps; challenging negative beliefs) and problem-solving skills (assertiveness; relaxation and distraction; overcoming procrastination; decision-making) in order to cope with stressful situations. | Behavioural | 1 |
| Waitlist ControlAlso: R4Power2Adolescents in the waitlist control group will complete the R4Power program during the second year of the study. | Other | 2 |
Primary outcome
Adolescents' coping strategies by self-report
Time frame: Measured at baseline and follow-ups approximately 4, 12, and 16 months after baseline
Adolescents' depressive symptoms by self-report
Time frame: Measured at baseline and follow-ups approximately 4, 12, and 16 months after baseline
1 secondary outcome
Adolescents' symptoms of anxiety by self-report
Time frame: Measured at baseline and follow-ups approximately 4, 12, and 16 months after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2008.
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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.
Jane E. Gillham, Ph.D. principal investigator
Swarthmore College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing R4Power Program in people with Depression and Anxiety, run by Swarthmore College 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 2 inclusion and 1 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 24 Mar 2008. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jane E. Gillham, Ph.D. (610-957-6010, info@positivepsych.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescents' coping strategies by self-report (time frame: Measured at baseline and follow-ups approximately 4, 12, and 16 months after baseline). The study lists 2 primary outcomes in all. 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 24 Mar 2008.