Behavior and Behavior MechanismsFTT+NCT04731649
Families Talking Together Plus: An Approach to Promote Sexual Delay and Strengthen Sexual Risk Avoidance Education
A study testing Families Talking Together Plus (FTT +) in people with Behavior and Behavior Mechanisms, run by Johns Hopkins University at 1 site in United States.
Trial summary
Despite reductions in adolescent sexual behavior over the past decade, premature sexual activity remains prevalent among adolescents and alarming adolescent sexual and reproductive health (SRH) disparities exist. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior and Behavior Mechanisms
- What is being tested?
- Families Talking Together Plus (FTT +)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,227 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 27 Sep 2024
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents must be between the ages of 12 and 17 years old
- Adolescent must identify as Latino or Black
- Adolescent has a primary caregiver
- Residence in Mott Haven, South Bronx
Who cannot join
- Adolescent is not between the ages of 12-17
- Adolescent is not Latino or Black
- Adolescent does not have a primary caregiver
- Non-resident of Mott Haven, South Bronx
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Families Talking Together Plus (FTT+): An Online, Family-Based Approach to Promote Sexual Delay and Strengthen the Evidence-Base for Sexual Risk Avoidance Education
Despite reductions in adolescent sexual behavior over the past decade, premature sexual activity remains prevalent among adolescents and alarming adolescent sexual and reproductive health (SRH) disparities exist. Positive youth development (PYD) research has identified adolescent protective factors, such as success sequencing, self-regulation, goal setting, and strong family support [i.e., positive family development (PFD)] that are associated with increased sexual risk avoidance as well as individual life opportunities and societal benefits. Needed are programmatic efforts to strengthen adolescent protective factors among populations in greatest need, with a particular emphasis on the important role of parents in promoting sexual delay. The proposed project is designed to target Latino and Black adolescents aged 12-17 years residing in the South Bronx, New York City, a high-need community for sexual risk programming and promotion of adolescent life opportunities. The investigators evaluate a program called Families Talking Together Plus (FTT+), an online, parent-based intervention that is medically accurate, culturally tailored, and age-appropriate. To implement FTT +, the investigators draw upon an innovative and culturally competent intervention delivery approach, namely community health workers (CHWs) as "Life Opportunity Coaches."
Read the detailed description
Despite reductions in adolescent sexual behavior over the past decade, premature sexual activity remains prevalent among adolescents and alarming adolescent sexual and reproductive health (SRH) disparities exist. The adverse short and long-term consequences of premature adolescent sexual behavior are well-documented, including negative effects on the physical, emotional, social, and economic well-being of youth. Positive youth development (PYD) research has identified adolescent protective factors, such as success sequencing, self-regulation, goal setting, and strong family support [i.e., positive family development (PFD)] that are associated with increased sexual risk avoidance as well as individual life opportunities and societal benefits.
Families Talking Together Plus (FTT +) is an online intervention designed to reduce adolescent sexual risk behavior through supporting caregiver-adolescent communication about sex. The goals of the program are to (1) delay sexual debut, (2) reduce sexual behavior, (3) increase correct and consistent condom use, and (4) increase engagement with community resources among Black and Latino adolescents aged 12-17 years (n=600) residing in a community with disparate adolescent SRH outcomes and high need for improved adolescent life opportunities and success sequencing support, the South Bronx, New York City.
The 2-arm parallel randomized controlled trial (RCT) will evaluate the efficacy of the FTT + intervention in delaying sexual debut, reducing adolescent sexual behavior, and linking adolescents to community resources and services for sexual risk behavior, PYD, and success sequencing. The investigators will recruit adolescents and the primary adult caregivers in the homes using area sampling methods piloted-tested by Center for Latino Adolescent and Family Health (CLAFH) staff with excellent results in our previous research in the target community. Parents and adolescents will complete a questionnaire (separately) at baseline assessments. Subsequently, parent-adolescent dyads will be randomly assigned to either, (1) the experimental group (who will receive the FTT + intervention), or (2) the control group that does not receive any intervention. The baseline sample size will be 600 dyads, with 300 dyads in each group.
Parents randomized to the experimental condition will receive three 60 to 90 minute virtual intervention sessions consisting of 9 modules delivered to the parent by community healthcare workers. Intervention sessions should happen within the first month following the baseline interview. FTT + modules address self-regulation, success sequencing, the benefits of delaying sex, correctly using a condom every time, healthy relationships, goal setting, resisting sexual coercion, dating violence, and other youth risk behaviors such as underage drinking or illicit drug use. In addition, parents receive guidance on effective adolescent monitoring and supervision and strengthening the relationship quality with the adolescent.
- Conditions
- Behavior and Behavior Mechanisms
- Being tested
- Families Talking Together Plus (FTT +)
- Keywords
- Families Talking Together, Adolescent Sexual Health, Community Health Workers, Prevention
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Families Talking Together Plus (FTT +)Behavioural
FTT + consists of three online intervention sessions of approximately 60-90 minutes each, that cover content from nine modules designed to teach parents effective communication skills, build parent-adolescent relationships, help parents develop successful monitoring strategies, and teach adolescents assertiveness, refusal skills, and how to use a condom correctly and every time.
| Study group | Role | What they receive |
|---|---|---|
| Sex Education + Standard Care | Experimental | The experimental arm will receive the FTT + intervention Receives: Behavioral: Families Talking Together Plus (FTT +) |
| No Education + Standard Care | No intervention | The control arm will not receive the FTT + intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Debut/Ever Sex (Vaginal)
Defined as adolescent report of having engaged in vaginal sex.
Measured: 9-month post-intervention
Sexual Debut/Ever Sex (Anal)
Defined as adolescent report of having engaged in anal sex.
Measured: 9-month post-intervention
Sexual Debut/Ever Sex (Oral)
Defined as adolescent report of having engaged in oral sex.
Measured: 9-month post-intervention
Secondary outcomes (17)
Frequency of Vaginal Sex Acts
Defined as number of vaginal sex acts within a 6-month period
Measured: 9-month post-intervention
Frequency of Anal Sex Acts
Defined as number of anal sex acts within a 6-month period
Measured: 9-month post-intervention
Frequency of Oral Sex Acts
Defined as number of oral sex acts within a 6-month period
Measured: 9-month post-intervention
Number of Sexual Partners
Defined as the number of different sexual partners within a 6-month period
Measured: 9-month post-intervention
Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale
Defined as frequency of adolescent condom use during vaginal, anal, and oral sex acts, with higher scores indicating greater consistency of condom use [Minimum Score= 0% - indicates that no condom was used during any type of sex act in the past 6 months, Maximum Score= 100% - indicates that a new condom was used for every sex act in the past 6 months.
Measured: 9-month post-intervention
Uptake of Sexually Transmitted Infection (STI) Testing
Defined as adolescent report of utilizing STI testing.
Measured: 9-month post-intervention
Adolescent Linkage to Community and Healthcare Services: As Measured using the Utilization of Community Resources Scale
Measured using the Utilization of Community Resources Scale, with higher scores indicating greater linkage to to services in the community addressing current needs (e.g., food insecurity) \& economic capital (e.g., job training) [Minimum score = 0 - indicates no linkage to any services listed; Maximum score= 12- indicates linkage to all types of services listed in scale].
Measured: 9-month post-intervention
Sexual Debut/Ever Sex (Vaginal)
Defined as adolescent report of having engaged in vaginal sex.
Measured: 3-month post-intervention
Sexual Debut/Ever Sex (Anal)
Defined as adolescent report of having engaged in anal sex.
Measured: 3-month post-intervention
Sexual Debut/Ever Sex (Oral)
Defined as adolescent report of having engaged in oral sex.
Measured: 3-month post-intervention
Frequency of Vaginal Sex Acts
Defined as number of vaginal sex acts within a 3-month period
Measured: 3-month post-intervention
Frequency of Anal Sex Acts
Defined as number of anal sex acts within a 3-month period
Measured: 3-month post-intervention
Frequency of Oral Sex Acts
Defined as number of oral sex acts within a 3-month period
Measured: 3-month post-intervention
Number of Sexual Partners
Defined as the number of different sexual partners within a 3-month period
Measured: 3-month post-intervention
Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale
Defined as frequency of adolescent condom use during vaginal, anal, and oral sex acts, with higher scores indicating greater consistency of condom use [Minimum Score= 0% - indicating no condom use during any type of sex act in the past 3 months, Maximum Score= 100% - indicating condom use for every sex act in the past 3 months.
Measured: 3-month post-intervention
Uptake of STI Testing
Defined as adolescent report of utilizing STI testing.
Measured: 3-month post-intervention
Adolescent Linkage to Community and Healthcare Services: As Measured using the Utilization of Community Resources Scale
Measured using the Utilization of Community Resources Scale, with higher scores indicating greater linkage to services in the community addressing current needs (e.g., food insecurity) \& economic capital (e.g., job training) [.minimum score =0 - indicating no linkage to any services listed; maximum score=12- indicating linkage to all types of services listed in scale].
Measured: 3-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start1 Mar 2021
- Primary completion27 Sep 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavior and Behavior MechanismsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Guilamo-Ramos, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731649
- Sponsor's protocol ID
- IRB00426772
- Other IDs
- 90SR0113-01-00, PRO00108607
- Acronym
- FTT+
- Status last verified
- Oct 2024
- First submitted
- 26 Jan 2021
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guilamo-Ramos V, Benzekri A, Thimm-Kaiser M. Evaluating the efficacy of an online, family-based intervention to promote adolescent sexual health: a study protocol for a randomized controlled trial. Trials. 2023 Mar 11;24(1):181. doi: 10.1186/s13063-023-07205-3.
PubMed 36906589
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Families Talking Together Plus (FTT+): An Online, Family-Based Approach to Promote Sexual Delay and Strengthen the Evidence-Base for Sexual Risk Avoidance Education
- ClinicalTrials.gov ID
- NCT04731649
- Acronym / sponsor ID
- FTT+ / IRB00426772
- Conditions
- Behavior and Behavior Mechanisms
- Keywords
- Families Talking Together, Adolescent Sexual Health, Community Health Workers, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,227 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 1 Feb 2021 (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.
Despite reductions in adolescent sexual behavior over the past decade, premature sexual activity remains prevalent among adolescents and alarming adolescent sexual and reproductive health (SRH) disparities exist. Positive youth development (PYD) research has identified adolescent protective factors, such as success sequencing, self-regulation, goal setting, and strong family support [i.e., positive family development (PFD)] that are associated with increased sexual risk avoidance as well as individual life opportunities and societal benefits. Needed are programmatic efforts to strengthen adolescent protective factors among populations in greatest need, with a particular emphasis on the important role of parents in promoting sexual delay. The proposed project is designed to target Latino and Black adolescents aged 12-17 years residing in the South Bronx, New York City, a high-need community for sexual risk programming and promotion of adolescent life opportunities. The investigators evaluate a program called Families Talking Together Plus (FTT+), an online, parent-based intervention that is medically accurate, culturally tailored, and age-appropriate. To implement FTT +, the investigators draw upon an innovative and culturally competent intervention delivery approach, namely community health workers (CHWs) as "Life Opportunity Coaches."
Detailed description
Despite reductions in adolescent sexual behavior over the past decade, premature sexual activity remains prevalent among adolescents and alarming adolescent sexual and reproductive health (SRH) disparities exist. The adverse short and long-term consequences of premature adolescent sexual behavior are well-documented, including negative effects on the physical, emotional, social, and economic well-being of youth. Positive youth development (PYD) research has identified adolescent protective factors, such as success sequencing, self-regulation, goal setting, and strong family support [i.e., positive family development (PFD)] that are associated with increased sexual risk avoidance as well as individual life opportunities and societal benefits.
Families Talking Together Plus (FTT +) is an online intervention designed to reduce adolescent sexual risk behavior through supporting caregiver-adolescent communication about sex. The goals of the program are to (1) delay sexual debut, (2) reduce sexual behavior, (3) increase correct and consistent condom use, and (4) increase engagement with community resources among Black and Latino adolescents aged 12-17 years (n=600) residing in a community with disparate adolescent SRH outcomes and high need for improved adolescent life opportunities and success sequencing support, the South Bronx, New York City.
The 2-arm parallel randomized controlled trial (RCT) will evaluate the efficacy of the FTT + intervention in delaying sexual debut, reducing adolescent sexual behavior, and linking adolescents to community resources and services for sexual risk behavior, PYD, and success sequencing. The investigators will recruit adolescents and the primary adult caregivers in the homes using area sampling methods piloted-tested by Center for Latino Adolescent and Family Health (CLAFH) staff with excellent results in our previous research in the target community. Parents and adolescents will complete a questionnaire (separately) at baseline assessments. Subsequently, parent-adolescent dyads will be randomly assigned to either, (1) the experimental group (who will receive the FTT + intervention), or (2) the control group that does not receive any intervention. The baseline sample size will be 600 dyads, with 300 dyads in each group.
Parents randomized to the experimental condition will receive three 60 to 90 minute virtual intervention sessions consisting of 9 modules delivered to the parent by community healthcare workers. Intervention sessions should happen within the first month following the baseline interview. FTT + modules address self-regulation, success sequencing, the benefits of delaying sex, correctly using a condom every time, healthy relationships, goal setting, resisting sexual coercion, dating violence, and other youth risk behaviors such as underage drinking or illicit drug use. In addition, parents receive guidance on effective adolescent monitoring and supervision and strengthening the relationship quality with the adolescent.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sex Education + Standard Care | Experimental | Behavioral: Families Talking Together Plus (FTT +)The experimental arm will receive the FTT + intervention |
| No Education + Standard Care | No intervention | –The control arm will not receive the FTT + intervention |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Adolescents must be between the ages of 12 and 17 years old
- Adolescent must identify as Latino or Black
- Adolescent has a primary caregiver
- Residence in Mott Haven, South Bronx
Key exclusion criteria (4 listed)
- Adolescent is not between the ages of 12-17
- Adolescent is not Latino or Black
- Adolescent does not have a primary caregiver
- Non-resident of Mott Haven, South Bronx
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 |
|---|---|---|
| Families Talking Together Plus (FTT +)FTT + consists of three online intervention sessions of approximately 60-90 minutes each, that cover content from nine modules designed to teach parents effective communication skills, build parent-adolescent relationships, help parents develop successful monitoring strategies, and teach adolescents assertiveness, refusal skills, and how to use a condom correctly and every time. | Behavioural | Sex Education + Standard Care |
Primary outcome
Sexual Debut/Ever Sex (Vaginal)
Time frame: 9-month post-intervention
Defined as adolescent report of having engaged in vaginal sex.
Sexual Debut/Ever Sex (Anal)
Time frame: 9-month post-intervention
Defined as adolescent report of having engaged in anal sex.
Sexual Debut/Ever Sex (Oral)
Time frame: 9-month post-intervention
Defined as adolescent report of having engaged in oral sex.
17 secondary outcomes
Frequency of Vaginal Sex Acts
Time frame: 9-month post-intervention
Frequency of Anal Sex Acts
Time frame: 9-month post-intervention
Frequency of Oral Sex Acts
Time frame: 9-month post-intervention
Number of Sexual Partners
Time frame: 9-month post-intervention
Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale
Time frame: 9-month post-intervention
Uptake of Sexually Transmitted Infection (STI) Testing
Time frame: 9-month post-intervention
Adolescent Linkage to Community and Healthcare Services: As Measured using the Utilization of Community Resources Scale
Time frame: 9-month post-intervention
Sexual Debut/Ever Sex (Vaginal)
Time frame: 3-month post-intervention
Sexual Debut/Ever Sex (Anal)
Time frame: 3-month post-intervention
Sexual Debut/Ever Sex (Oral)
Time frame: 3-month post-intervention
Frequency of Vaginal Sex Acts
Time frame: 3-month post-intervention
Frequency of Anal Sex Acts
Time frame: 3-month post-intervention
Frequency of Oral Sex Acts
Time frame: 3-month post-intervention
Number of Sexual Partners
Time frame: 3-month post-intervention
Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale
Time frame: 3-month post-intervention
Uptake of STI Testing
Time frame: 3-month post-intervention
Adolescent Linkage to Community and Healthcare Services: As Measured using the Utilization of Community Resources Scale
Time frame: 3-month post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Derived from this study: PubMed 36906589Guilamo-Ramos V, Benzekri A, Thimm-Kaiser M. Evaluating the efficacy of an online, family-based intervention to promote adolescent sexual health: a study protocol for a randomized controlled trial. Trials. 2023 Mar 11;24(1):181. doi: 10.1186/s13063-023-07205-3.
- Study ProtocolLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Vincent Guilamo-Ramos, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Families Talking Together Plus (FTT +) in people with Behavior and Behavior Mechanisms, run by Johns Hopkins University 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 10 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Debut/Ever Sex (Vaginal) (time frame: 9-month post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04731649, which also lists 1 linked publication.
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 10 Oct 2024.