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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00641368
Other study ID # 07-08-003
Secondary ID
Status Recruiting
Phase Phase 1
First received March 17, 2008
Last updated March 17, 2008
Start date October 2007
Est. completion date October 2009

Study information

Verified date March 2008
Source Swarthmore College
Contact Jane E. Gillham, Ph.D.
Phone 610-957-6010
Email info@positivepsych.org
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The study will evaluate the R4Power program, an online intervention designed to teach adolescents coping and problem-solving skills.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 11 Years to 15 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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:
Waitlist Control
Adolescents in the waitlist control group will complete the R4Power program during the second year of the study.

Locations

Country Name City State
United States Swarthmore College Swarthmore Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Swarthmore College

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adolescents' coping strategies by self-report Measured at baseline and follow-ups approximately 4, 12, and 16 months after baseline No
Primary Adolescents' depressive symptoms by self-report Measured at baseline and follow-ups approximately 4, 12, and 16 months after baseline No
Secondary Adolescents' symptoms of anxiety by self-report Measured at baseline and follow-ups approximately 4, 12, and 16 months after baseline No
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