Clinical trial NCT04044027: Evaluation of the Spark of Duval Intervention
Official title: Evaluation of the Spark of Duval, an Innovative Teen Pregnancy Prevention Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Teen Pregnancy Prevention
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 400
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Sex Initiation
timeFrame: 3 months and 6 months
measure: Change in Sexual Activity in the Past Three Months
timeFrame: 3 months and 6 months
measure: Change in Condom and Birth Control Use during Sex
timeFrame: 3 months and 6 months
measure: Change in Pregnancy Occurrence
timeFrame: 3 months and 6 months
measure: Change in Behaviors
timeFrame: 3 months and 6 months
Secondary outcomes:
measure: Change in Connections with Peers
timeFrame: 3 months and 6 months
measure: Change in Relationships with People
timeFrame: 3 months and 6 months
measure: Change in Basic Life Skills
timeFrame: 3 months and 6 months
measure: Change in Educational Expectations and Academic Success
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
References: