- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00641368
R4Power: An Online Resilience Program for Adolescents (R4Power)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Jane E. Gillham, Ph.D.
- Phone Number: 610-957-6010
- Email: info@positivepsych.org
Study Locations
-
-
Pennsylvania
-
Swarthmore, Pennsylvania, United States, 19081
- Recruiting
- Swarthmore College
-
Contact:
- Jane E. Gillham, Ph.D.
- Phone Number: 610-957-6010
- Email: info@positivepsych.org
-
Principal Investigator:
- Jane E. Gillham, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Below 6th grade reading level, as reported by parents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
R4Power Program
|
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.
Other Names:
|
Other: 2
Waitlist Control
|
Adolescents in the waitlist control group will complete the R4Power program during the second year of the study.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adolescents' coping strategies by self-report
Time Frame: Measured at baseline and follow-ups approximately 4, 12, and 16 months after baseline
|
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
|
Measured at baseline and follow-ups approximately 4, 12, and 16 months after baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adolescents' symptoms of anxiety by self-report
Time Frame: Measured at baseline and follow-ups approximately 4, 12, and 16 months after baseline
|
Measured at baseline and follow-ups approximately 4, 12, and 16 months after baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jane E. Gillham, Ph.D., Swarthmore College
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-08-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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