Behavior and Behavior MechanismsNCT01326806
A Parent-Based Intervention to Reduce Sexual Risk Behavior in Adolescents
A study testing Families Talking Together in people with Behavior and Behavior Mechanisms, run by New York University at 1 site in United States.
Trial summary
The purpose of this study is to test the feasibility and efficacy of a triadic intervention designed to target both healthcare providers and parents in order to prevent adolescent sexual risk behavior in Latino and African American adolescents. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior and Behavior Mechanisms
- What is being tested?
- Families Talking Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2012to 31 May 2016
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents must be between the ages of 11 and 14 years old
- Adolescent is able to agree to being a participant
- Participant must be able to participate in questionnaire and intervention activities
- Participant must be of Latino or African American descent
Who cannot join
- Any cognitive or psychiatric disability that would prevent successful participation in questionnaire or intervention activities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Teen Sexual Behavior: A Clinic-Based Approach
The purpose of this study is to test the feasibility and efficacy of a triadic intervention designed to target both healthcare providers and parents in order to prevent adolescent sexual risk behavior in Latino and African American adolescents. The intervention will be administered in the context of mothers waiting for their children to complete a non-acute care visit.
Read the detailed description
In the United States, racial and ethnic minorities suffer disproportionately from preventable diseases and conditions. Many of these problems result from health-related behaviors that are established during childhood and adolescence. Latino and African-American adolescents are at considerable risk for the negative consequences of early, risky sexual activity. This study will focus on Latino and African-American early adolescents ages 11 to 14.
The primary aim for this study will be to test and refine a triadic intervention developed for healthcare providers and parents to address the issue of sexual risk behavior among African American and Latino adolescents.
The triadic intervention will take place in a pediatric health care clinic when mothers accompany their children for a non-acute care visit. Mothers will meet with a provider extender (medical assistant, social worker, counselor) for approximately 30 minutes while their children are being examined by a healthcare provider. During this time, mothers will receive information about the problem of premature adolescent sexual activity, support in preventing or reducing their children's sexual risk behavior, instruction about how to talk with their children about sexual risk behavior, and targeted homework activities. The healthcare provider will endorse the intervention separately for mothers and adolescents. All parents will also receive one follow-up phone call to increase the probability that the homework tasks will be completed.
Participants in this study will also be assigned to one of the following three groups: an experimental group; an active control group; or a passive control group. Participants in all groups will complete three questionnaires over the course of the study to assess outcomes. Participants in the experimental and active control groups will partake in an intervention session with a provider extender. Parents in the experimental group will meet with the provider extender to discuss effective parent-adolescent communication strategies. They will also receive take-home materials to help them communicate with and parent their adolescents to reduce sexual risk behavior. Parents in the active control group will meet with the provider extender to discuss adolescent nutrition and receive informational brochures.
One booster session will take place via telephone for parents in the experimental and active control groups. The booster call will occur approximately 1 month after study entry. No such booster calls will be provided to parents in the passive control condition.
- Conditions
- Behavior and Behavior Mechanisms
- Being tested
- Families Talking Together, Active Control on Hygiene & Nutrition
- Keywords
- Parent-based intervention, Sexual risk behavior, Adolescents
- 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 TogetherBehavioural
The intervention will take place in a pediatric health care clinic and will be coordinated through provider extenders when healthcare providers see youth fora non-acute care visit. A mother of the adolescent will meet with a provider extender for approximately 30 minutes while her child is being examined by a healthcare provider. During this time, the intervention will be delivered to the mother. At the conclusion of the session, the mother will be given reference materials to take home and tasks to perform to facilitate discussions about sex with her adolescent. The healthcare provider will endorse the intervention separately for mothers and adolescents. There will be one follow-up booster session administered through phone calls to increase completion probabilities of the tasks. The target behavior is sexual activity in adolescents.
Active Control on Hygiene & NutritionBehavioural
The active control group will take place in a pediatric health care clinic and will be coordinated through provider extenders when healthcare providers see youth for a non-acute care visit. The mother of the adolescent will meet with a provider extender for approximately 30 minutes while her child is being examined by a healthcare provider. During this time, the active control on hygiene and nutrition will be delivered to the mother.
| Study group | Role | What they receive |
|---|---|---|
| Sex Education + Standard Care | Experimental | Participating mothers will receive sex education information while their child is having a physical exam. Receives: Behavioral: Families Talking Together |
| Hygiene & Nutrition Education + Standard Care | Active comparator | Participating mothers will receive information on hygiene and nutrition while their child is having a physical exam. Receives: Behavioral: Active Control on Hygiene & Nutrition |
| No Education + Standard Care | No intervention | Participating mothers who are passive controls will not receive any additional information while their child is having a physical exam. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of vaginal intercourse
Measured: Measured at 12 months post-intervention
Incidence of condom use
Measured: Measured at 12-months post-intervention
Secondary outcomes (6)
Number of sexual partners
Measured: Measured at 12 months post-intervention
Behavioral intentions
Behavioral intentions to engage in sexual intercourse will be assessed based on responses to three statements, each using a five point agree-disagree scale. The items are: (a) I think I am ready to have sexual intercourse; (b) I would have sexual intercourse now if I had a boy who would do it with me; and (c) I plan on having sexual intercourse in the next six months.
Measured: Measured at 12 months post-intervention
Incidence of vaginal intercourse
Measured: Measured at 3 months post-intervention
Incidence of condom use
Measured: Measured at 3 months post-intervention
Number of sexual partners
Measured: Measured at 3 months post-intervention
Behavioral intentions
Behavioral intentions to engage in sexual intercourse will be assessed based on responses to three statements, each using a five point agree-disagree scale. The items are: (a) I think I am ready to have sexual intercourse; (b) I would have sexual intercourse now if I had a boy who would do it with me; and (c) I plan on having sexual intercourse in the next six months.
Measured: Measured at 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2011 (estimated)
- Study start15 Feb 2012
- Primary completion31 May 2016
- Study completion31 May 2016
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.
- 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
- Participant
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Vincent Guilamo-Ramos, PhD, ANP-BC, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326806
- Sponsor's protocol ID
- NIH_066159
- Other IDs
- R01HD066159
- Status last verified
- Apr 2019
- First submitted
- 28 Mar 2011
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guilamo-Ramos V, Benzekri A, Thimm-Kaiser M, Dittus P, Ruiz Y, Cleland CM, McCoy W. A Triadic Intervention for Adolescent Sexual Health: A Randomized Clinical Trial. Pediatrics. 2020 May;145(5):e20192808. doi: 10.1542/peds.2019-2808.
PubMed 32345685
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Teen Sexual Behavior: A Clinic-Based Approach
- ClinicalTrials.gov ID
- NCT01326806
- Acronym / sponsor ID
- NIH_066159
- Conditions
- Behavior and Behavior Mechanisms
- Keywords
- Parent-based intervention, Sexual risk behavior, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 15 Feb 2012 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 31 May 2016 (actual)
- First posted
- 31 Mar 2011 (estimated)
- 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 purpose of this study is to test the feasibility and efficacy of a triadic intervention designed to target both healthcare providers and parents in order to prevent adolescent sexual risk behavior in Latino and African American adolescents. The intervention will be administered in the context of mothers waiting for their children to complete a non-acute care visit.
Detailed description
In the United States, racial and ethnic minorities suffer disproportionately from preventable diseases and conditions. Many of these problems result from health-related behaviors that are established during childhood and adolescence. Latino and African-American adolescents are at considerable risk for the negative consequences of early, risky sexual activity. This study will focus on Latino and African-American early adolescents ages 11 to 14.
The primary aim for this study will be to test and refine a triadic intervention developed for healthcare providers and parents to address the issue of sexual risk behavior among African American and Latino adolescents.
The triadic intervention will take place in a pediatric health care clinic when mothers accompany their children for a non-acute care visit. Mothers will meet with a provider extender (medical assistant, social worker, counselor) for approximately 30 minutes while their children are being examined by a healthcare provider. During this time, mothers will receive information about the problem of premature adolescent sexual activity, support in preventing or reducing their children's sexual risk behavior, instruction about how to talk with their children about sexual risk behavior, and targeted homework activities. The healthcare provider will endorse the intervention separately for mothers and adolescents. All parents will also receive one follow-up phone call to increase the probability that the homework tasks will be completed.
Participants in this study will also be assigned to one of the following three groups: an experimental group; an active control group; or a passive control group. Participants in all groups will complete three questionnaires over the course of the study to assess outcomes. Participants in the experimental and active control groups will partake in an intervention session with a provider extender. Parents in the experimental group will meet with the provider extender to discuss effective parent-adolescent communication strategies. They will also receive take-home materials to help them communicate with and parent their adolescents to reduce sexual risk behavior. Parents in the active control group will meet with the provider extender to discuss adolescent nutrition and receive informational brochures.
One booster session will take place via telephone for parents in the experimental and active control groups. The booster call will occur approximately 1 month after study entry. No such booster calls will be provided to parents in the passive control condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sex Education + Standard Care | Experimental | Behavioral: Families Talking TogetherParticipating mothers will receive sex education information while their child is having a physical exam. |
| Hygiene & Nutrition Education + Standard Care | Active comparator | Behavioral: Active Control on Hygiene & NutritionParticipating mothers will receive information on hygiene and nutrition while their child is having a physical exam. |
| No Education + Standard Care | No intervention | –Participating mothers who are passive controls will not receive any additional information while their child is having a physical exam. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Adolescents must be between the ages of 11 and 14 years old
- Adolescent is able to agree to being a participant
- Participant must be able to participate in questionnaire and intervention activities
- Participant must be of Latino or African American descent
Key exclusion criteria (1 listed)
- Any cognitive or psychiatric disability that would prevent successful participation in questionnaire or intervention activities
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 TogetherThe intervention will take place in a pediatric health care clinic and will be coordinated through provider extenders when healthcare providers see youth fora non-acute care visit. A mother of the adolescent will meet with a provider extender for approximately 30 minutes while her child is being examined by a healthcare provider. During this time, the intervention will be delivered to the mother. At the conclusion of the session, the mother will be given reference materials to take home and tasks to perform to facilitate discussions about sex with her adolescent. The healthcare provider will endorse the intervention separately for mothers and adolescents. There will be one follow-up booster session administered through phone calls to increase completion probabilities of the tasks. The target behavior is sexual activity in adolescents. | Behavioural | Sex Education + Standard Care |
| Active Control on Hygiene & NutritionThe active control group will take place in a pediatric health care clinic and will be coordinated through provider extenders when healthcare providers see youth for a non-acute care visit. The mother of the adolescent will meet with a provider extender for approximately 30 minutes while her child is being examined by a healthcare provider. During this time, the active control on hygiene and nutrition will be delivered to the mother. | Behavioural | Hygiene & Nutrition Education + Standard Care |
Primary outcome
Incidence of vaginal intercourse
Time frame: Measured at 12 months post-intervention
Incidence of condom use
Time frame: Measured at 12-months post-intervention
6 secondary outcomes
Number of sexual partners
Time frame: Measured at 12 months post-intervention
Behavioral intentions
Time frame: Measured at 12 months post-intervention
Incidence of vaginal intercourse
Time frame: Measured at 3 months post-intervention
Incidence of condom use
Time frame: Measured at 3 months post-intervention
Number of sexual partners
Time frame: Measured at 3 months post-intervention
Behavioral intentions
Time frame: Measured at 3 months 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 27 Oct 2022.
- Derived from this study: PubMed 32345685Guilamo-Ramos V, Benzekri A, Thimm-Kaiser M, Dittus P, Ruiz Y, Cleland CM, McCoy W. A Triadic Intervention for Adolescent Sexual Health: A Randomized Clinical Trial. Pediatrics. 2020 May;145(5):e20192808. doi: 10.1542/peds.2019-2808.
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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, ANP-BC principal investigator
New York 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 in people with Behavior and Behavior Mechanisms, run by New York 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 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: finished, as of the sponsor's last update on 27 Oct 2022. 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?
Incidence of vaginal intercourse (time frame: Measured at 12 months post-intervention). The study lists 2 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 NCT01326806, 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 27 Oct 2022; AzTrials last refreshed its copy on 30 Oct 2026.