Teen Pregnancy PreventionNCT04044027
Evaluation of the Spark of Duval Intervention
A study testing S.P.A.R.K (Speaking to the Potential, Ability and Resilience inside Kids) Teen Pregnancy Prevention and Mentoring in people with Teen Pregnancy Prevention, run by University of South Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Teen Pregnancy Prevention
- What is being tested?
- S.P.A.R.K (Speaking to the Potential, Ability and Resilience inside Kids) Teen Pregnancy Prevention and Mentoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2017to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Youth who are teen parents, expectant parents, or currently living in residential facilities are excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of South Florida
Tampa, Florida, 33621
Svetlana Yampolskaya, Phd, 813-974-8218, yampol@usf.edu
Cathy Sowell, 813-974-3628, csowell@usf.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Teen Pregnancy Prevention
- Being tested
- S.P.A.R.K (Speaking to the Potential, Ability and Resilience inside Kids) Teen Pregnancy Prevention and Mentoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S.P.A.R.K (Speaking to the Potential, Ability and Resilience inside Kids) Teen Pregnancy Prevention and MentoringBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| Intervention Group | Experimental | Not described Receives: Behavioral: S.P.A.R.K (Speaking to the Potential, Ability and Resilience inside Kids) Teen Pregnancy Prevention and Mentoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sex Initiation
Yes or No question regarding sexual activity
Measured: 3 months and 6 months
Change in Sexual Activity in the Past Three Months
Number of times vaginal sex occurred in the past three months.
Measured: 3 months and 6 months
Change in Condom and Birth Control Use during Sex
Frequency of condom use
Measured: 3 months and 6 months
Change in Pregnancy Occurrence
Yes or No question regarding pregnancy
Measured: 3 months and 6 months
Change in Behaviors
Survey questionnaire related to adolescent behaviors.
Measured: 3 months and 6 months
Secondary outcomes (4)
Change in Connections with Peers
Survey questionnaire related to connections with peers.
Measured: 3 months and 6 months
Change in Relationships with People
Survey questionnaire related to relationships with people.
Measured: 3 months and 6 months
Change in Basic Life Skills
Survey questionnaire related to basic life skills.
Measured: 3 months and 6 months
Change in Educational Expectations and Academic Success
Survey questionnaire related to education expectations and academic successes.
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start11 Apr 2017
- Primary completionJan 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teen Pregnancy PreventionStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Svetlana Yampolskaya, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044027
- Sponsor's protocol ID
- Pro00030249
- Status last verified
- Aug 2019
- First submitted
- 17 Jul 2019
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Spark of Duval, an Innovative Teen Pregnancy Prevention Program
- ClinicalTrials.gov ID
- NCT04044027
- Acronym / sponsor ID
- Pro00030249
- Conditions
- Teen Pregnancy Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| Intervention Group | Experimental | Behavioral: S.P.A.R.K (Speaking to the Potential, Ability and Resilience inside Kids) Teen Pregnancy Prevention and Mentoring |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Youth who are teen parents, expectant parents, or currently living in residential facilities are excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S.P.A.R.K (Speaking to the Potential, Ability and Resilience inside Kids) Teen Pregnancy Prevention and MentoringS.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. | Behavioural | Intervention Group |
Primary outcome
Change in Sex Initiation
Time frame: 3 months and 6 months
Yes or No question regarding sexual activity
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.
Change in Condom and Birth Control Use during Sex
Time frame: 3 months and 6 months
Frequency of condom use
Change in Pregnancy Occurrence
Time frame: 3 months and 6 months
Yes or No question regarding pregnancy
Change in Behaviors
Time frame: 3 months and 6 months
Survey questionnaire related to adolescent behaviors.
4 secondary outcomes
Change in Connections with Peers
Time frame: 3 months and 6 months
Change in Relationships with People
Time frame: 3 months and 6 months
Change in Basic Life Skills
Time frame: 3 months and 6 months
Change in Educational Expectations and Academic Success
Time frame: 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S.P.A.R.K (Speaking to the Potential, Ability and Resilience inside Kids) Teen Pregnancy Prevention and Mentoring in people with Teen Pregnancy Prevention, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Svetlana Yampolskaya, PhD (813-974-8218, yampol@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sex Initiation (time frame: 3 months and 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.