Evaluation of the Spark of Duval Intervention

Teen Pregnancy Prevention Clinical Trial

Official title:

Evaluation of the Spark of Duval, an Innovative Teen Pregnancy Prevention Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04044027
• Other study ID #: Pro00030249
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2017
• Est. completion date: April 2020

Study information

• Verified date: August 2019
• Source: University of South Florida
• Contact: Svetlana Yampolskaya, PhD
• Phone: 813-974-8218
• Email: yampol[@]usf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Teen Pregnancy Prevention

Intervention

Behavioral:
• S.P.A.R.K (Speaking to the Potential, Ability and Resilience inside Kids) Teen Pregnancy Prevention and Mentoring
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.

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Sex Initiation	Yes or No question regarding sexual activity	3 months and 6 months
Primary	Change in Sexual Activity in the Past Three Months	Number of times vaginal sex occurred in the past three months.	3 months and 6 months
Primary	Change in Condom and Birth Control Use during Sex	Frequency of condom use	3 months and 6 months
Primary	Change in Pregnancy Occurrence	Yes or No question regarding pregnancy	3 months and 6 months
Primary	Change in Behaviors	Survey questionnaire related to adolescent behaviors.	3 months and 6 months
Secondary	Change in Connections with Peers	Survey questionnaire related to connections with peers.	3 months and 6 months
Secondary	Change in Relationships with People	Survey questionnaire related to relationships with people.	3 months and 6 months
Secondary	Change in Basic Life Skills	Survey questionnaire related to basic life skills.	3 months and 6 months
Secondary	Change in Educational Expectations and Academic Success	Survey questionnaire related to education expectations and academic successes.	3 months and 6 months