- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04044027
Evaluation of the Spark of Duval Intervention
August 1, 2019 updated by: Svetlana Yampolskaya, University of South Florida
Evaluation of the Spark of Duval, an Innovative Teen Pregnancy Prevention Program
The S.P.A.R.K (Speaking to the Potential, Ability, and Resilience inside Kids) Teen Pregnancy Prevention and Mentoring program is being administered to youth (ages 11-17) living in out-of-home foster care in Duval County, Florida.
Children's Home Society of Florida in Jacksonville received grant funding for the implementation and evaluation of the S.P.A.R.K program.
The University of South Florida is examining the effects of intervention on reducing youth involvement in risky sexual behavior and incidents of teen pregnancy.
Study Overview
Status
Unknown
Conditions
Detailed Description
The evaluation is conducting an individual randomized controlled trial to test the S.P.A.R.K. (Speaking to the Potential, Ability, and Resilience inside Kids) Teen Pregnancy Prevention and Mentoring intervention with youth assigned to either the intervention or control group.
As youth are referred to the study, grantee staff confirm their eligibility and then work with the youth's child welfare case manager to obtain youth assent and parental consent.
Once approximately 40 to 60 youth are recruited, grantee staff selects a day for baseline survey administration.
Survey administration and group assignment take place at the grantee agency and incentives to complete the survey are provided including a gift card and snacks.
All eligible youth with a signed assent and informed consent forms are invited to attend the baseline survey administration and group assignment.
The evaluation team generates random numbers using computer software, and the grantee staff uses these numbers to indicate youth assignment to the intervention or control group, after youth have completed the baseline survey.
Study Type
Interventional
Enrollment (Anticipated)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
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Tampa, Florida, United States, 33621
- Recruiting
- University of South Florida
-
Contact:
- Svetlana Yampolskaya, Phd
- Phone Number: 813-974-8218
- Email: yampol@usf.edu
-
Contact:
- Cathy Sowell
- Phone Number: 813-974-3628
- Email: csowell@usf.edu
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Youth aged 11-17, living in out-of-home foster care in Duval County, FL (Florida) are eligible for participation. Only youth who have provided assent and have received parental/guardian informed consent are included in the study.
Exclusion Criteria:
- Youth who are teen parents, expectant parents, or currently living in residential facilities are excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Intervention Group
|
S.P.A.R.K is a curriculum-based group intervention for youth ages 11-17 living in out-of-home foster care.
The curriculum consists of 23 topical lessons made up of a combination of educational and interactive activities on each topic.
The curriculum covers four Adult Preparation Subjects (healthy relationships, educational and career success, healthy life skills, adolescent development) as well as mentoring, bully prevention, emotional competency, self-efficacy, communication, conflict resolution, and pregnancy prevention.
|
|
No Intervention: Control Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Sex Initiation
Time Frame: 3 months and 6 months
|
Yes or No question regarding sexual activity
|
3 months and 6 months
|
|
Change in Sexual Activity in the Past Three Months
Time Frame: 3 months and 6 months
|
Number of times vaginal sex occurred in the past three months.
|
3 months and 6 months
|
|
Change in Condom and Birth Control Use during Sex
Time Frame: 3 months and 6 months
|
Frequency of condom use
|
3 months and 6 months
|
|
Change in Pregnancy Occurrence
Time Frame: 3 months and 6 months
|
Yes or No question regarding pregnancy
|
3 months and 6 months
|
|
Change in Behaviors
Time Frame: 3 months and 6 months
|
Survey questionnaire related to adolescent behaviors.
|
3 months and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Connections with Peers
Time Frame: 3 months and 6 months
|
Survey questionnaire related to connections with peers.
|
3 months and 6 months
|
|
Change in Relationships with People
Time Frame: 3 months and 6 months
|
Survey questionnaire related to relationships with people.
|
3 months and 6 months
|
|
Change in Basic Life Skills
Time Frame: 3 months and 6 months
|
Survey questionnaire related to basic life skills.
|
3 months and 6 months
|
|
Change in Educational Expectations and Academic Success
Time Frame: 3 months and 6 months
|
Survey questionnaire related to education expectations and academic successes.
|
3 months and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 11, 2017
Primary Completion (Anticipated)
January 1, 2020
Study Completion (Anticipated)
April 1, 2020
Study Registration Dates
First Submitted
July 17, 2019
First Submitted That Met QC Criteria
August 1, 2019
First Posted (Actual)
August 2, 2019
Study Record Updates
Last Update Posted (Actual)
August 2, 2019
Last Update Submitted That Met QC Criteria
August 1, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- Pro00030249
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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