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R4Power: An Online Resilience Program for Adolescents (R4Power)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00641368
Recruitment Status : Unknown
Verified March 2008 by Swarthmore College.
Recruitment status was:  Recruiting
First Posted : March 24, 2008
Last Update Posted : March 24, 2008
Sponsor:
Information provided by:
Swarthmore College

Tracking Information
First Submitted Date  ICMJE March 17, 2008
First Posted Date  ICMJE March 24, 2008
Last Update Posted Date March 24, 2008
Study Start Date  ICMJE October 2007
Estimated Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2008)
Adolescents' symptoms of anxiety by self-report [ Time Frame: Measured at baseline and follow-ups approximately 4, 12, and 16 months after baseline ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE R4Power: An Online Resilience Program for Adolescents
Official Title  ICMJE R4Power: An Online Resilience Program for Adolescents
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Depression
  • Anxiety
Intervention  ICMJE
  • Behavioral: 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 Name: R4Power1
  • Other: Waitlist Control
    Adolescents in the waitlist control group will complete the R4Power program during the second year of the study.
    Other Name: R4Power2
Study Arms  ICMJE
  • Experimental: 1
    R4Power Program
    Intervention: Behavioral: R4Power Program
  • 2
    Waitlist Control
    Intervention: Other: Waitlist Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 17, 2008)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2009
Estimated Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00641368
Other Study ID Numbers  ICMJE 07-08-003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jane E. Gillham, Ph.D., Swarthmore College
Study Sponsor  ICMJE Swarthmore College
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jane E. Gillham, Ph.D. Swarthmore College
PRS Account Swarthmore College
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP