Behavior and Behavior MechanismsNCT00461487
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 Columbia University at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of a parent-based intervention in reducing sexual risk behavior in high-risk 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
- 530 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Aug 2010
- 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
- Adolescent must be between the ages of 11 and 14 years old, and in grades 6, 7, or 8
- Adolescent is able to agree to being a participant
- Able to participate in questionnaire and intervention activities
- Latino or African-American descent
Who cannot join
- Any cognitive or psychiatric disability that would prevent successful participation in questionnaires and intervention activities
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University School of Social Work
New York, New York, 10027
About this study
Official title: Reducing Teen Sexual Behavior: A Clinic-Based Approach
This study will evaluate the effectiveness of a parent-based intervention in reducing sexual risk behavior in high-risk Latino and African-American adolescents.
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 health consequences of early, risky sexual activity. This study will focus on inner-city Latino and African-American adolescents in grades 6, 7, and 8. The primary aim will be to develop an intervention that parents can use to address the issue of sexual risk behavior with their children.
The intervention will take place in a primary health care clinic when mothers accompany their children for annual physical exams. Mothers will meet with a social worker for approximately 25 minutes while their children are being examined by the physician. 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. All parents will also receive three follow-up phone calls 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 additional meeting with a clinic social worker. Parents in the experimental group will meet with the social worker 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 social worker to discuss adolescent nutrition and receive informational brochures.
Three booster sessions will take place via telephone for parents in the experimental and active control groups. The first booster call will occur approximately 1 month after study entry, the second will occur 5 months after the intervention ends, and the third will occur 9 months post intervention. No such booster calls will be provided to parents in the passive control condition.
- Conditions
- Behavior and Behavior Mechanisms
- Being tested
- Active control on hygiene and nutrition, Families Talking Together
- Keywords
- Adolescent Behavior, Communication, Health Behavior, Risk-Taking, Sexual Behavior
- Medical subject headings
- Behavior, Adolescent Behavior, Communication, Health Behavior, Risk-Taking, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active control on hygiene and nutritionBehavioural
The active control group will take place in a primary healthcare clinic and will be coordinated through allied health professionals when physicians see youth for their annual physical examination. The mother of the adolescent will meet with a social work interventionist for approximately 25 minutes while her child is being examined by the physician. During this time, the active control on hygiene and nutrition will be delivered to the mother.
Families Talking TogetherBehavioural
The intervention will take place in a primary healthcare clinic and will be coordinated through allied health professionals when physicians see youth for their annual physical examination. A mother of the adolescent will meet with a social work interventionist for approximately 25 minutes while her child is being examined by the physician. 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. There will be three follow-up booster sessions administered through phone calls to increase completion probabilities of the tasks. The target behavior is sexual activity in adolescents.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive sex education information during the physical exam Receives: Behavioral: Families Talking Together |
| 2 | Active comparator | Participants will receive information on hygiene and nutrition during the physical exam Receives: Behavioral: Active control on hygiene and nutrition |
| 3 | No intervention | Passive control participants will not receive any additional information during the physical exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of vaginal sexual intercourse measured
Measured: Measured at Months 3 and 12 post-treatment
Secondary outcomes (5)
Incidence of condom use
Measured: Measured at Months 3 and 12 post-treatment
Incidence of oral sex
Measured: Measured at Months 3 and 12 post-treatment
Incidence of anal sex
Measured: Measured at Months 3 and 12 post-treatment
Number of sexual partners
Measured: Measured at Months 3 and 12 post-treatment
Behavioral intentions
Measured: Measured at Months 3 and 12 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionAug 2009
- Study completionAug 2010
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 Columbia 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Vincent Guilamo-Ramos, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461487
- Sponsor's protocol ID
- AAAC1456
- Other IDs
- R34MH078719, DAHBR 9A-ASAP
- Status last verified
- Jul 2013
- First submitted
- 16 Apr 2007
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Guilamo-Ramos V, Bouris A, Jaccard J, Gonzalez B, McCoy W, Aranda D. A parent-based intervention to reduce sexual risk behavior in early adolescence: building alliances between physicians, social workers, and parents. J Adolesc Health. 2011 Feb;48(2):159-63. doi: 10.1016/j.jadohealth.2010.06.007.
PubMed 21257114
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. 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
- NCT00461487
- Acronym / sponsor ID
- AAAC1456
- Conditions
- Behavior and Behavior Mechanisms
- Keywords
- Adolescent Behavior, Communication, Health Behavior, Risk-Taking, Sexual Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 18 Apr 2007 (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.
This study will evaluate the effectiveness of a parent-based intervention in reducing sexual risk behavior in high-risk Latino and African-American adolescents.
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 health consequences of early, risky sexual activity. This study will focus on inner-city Latino and African-American adolescents in grades 6, 7, and 8. The primary aim will be to develop an intervention that parents can use to address the issue of sexual risk behavior with their children.
The intervention will take place in a primary health care clinic when mothers accompany their children for annual physical exams. Mothers will meet with a social worker for approximately 25 minutes while their children are being examined by the physician. 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. All parents will also receive three follow-up phone calls 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 additional meeting with a clinic social worker. Parents in the experimental group will meet with the social worker 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 social worker to discuss adolescent nutrition and receive informational brochures.
Three booster sessions will take place via telephone for parents in the experimental and active control groups. The first booster call will occur approximately 1 month after study entry, the second will occur 5 months after the intervention ends, and the third will occur 9 months post intervention. No such booster calls will be provided to parents in the passive control condition.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Families Talking TogetherParticipants will receive sex education information during the physical exam |
| 2 | Active comparator | Behavioral: Active control on hygiene and nutritionParticipants will receive information on hygiene and nutrition during the physical exam |
| 3 | No intervention | –Passive control participants will not receive any additional information during the physical exam |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Adolescent must be between the ages of 11 and 14 years old, and in grades 6, 7, or 8
- Adolescent is able to agree to being a participant
- Able to participate in questionnaire and intervention activities
- Latino or African-American descent
Key exclusion criteria (1 listed)
- Any cognitive or psychiatric disability that would prevent successful participation in questionnaires and 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 |
|---|---|---|
| Active control on hygiene and nutritionThe active control group will take place in a primary healthcare clinic and will be coordinated through allied health professionals when physicians see youth for their annual physical examination. The mother of the adolescent will meet with a social work interventionist for approximately 25 minutes while her child is being examined by the physician. During this time, the active control on hygiene and nutrition will be delivered to the mother. | Behavioural | 2 |
| Families Talking TogetherThe intervention will take place in a primary healthcare clinic and will be coordinated through allied health professionals when physicians see youth for their annual physical examination. A mother of the adolescent will meet with a social work interventionist for approximately 25 minutes while her child is being examined by the physician. 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. There will be three follow-up booster sessions administered through phone calls to increase completion probabilities of the tasks. The target behavior is sexual activity in adolescents. | Behavioural | 1 |
Primary outcome
Incidence of vaginal sexual intercourse measured
Time frame: Measured at Months 3 and 12 post-treatment
5 secondary outcomes
Incidence of condom use
Time frame: Measured at Months 3 and 12 post-treatment
Incidence of oral sex
Time frame: Measured at Months 3 and 12 post-treatment
Incidence of anal sex
Time frame: Measured at Months 3 and 12 post-treatment
Number of sexual partners
Time frame: Measured at Months 3 and 12 post-treatment
Behavioral intentions
Time frame: Measured at Months 3 and 12 post-treatment
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 11 Jul 2013.
- Derived from this study: PubMed 21257114Guilamo-Ramos V, Bouris A, Jaccard J, Gonzalez B, McCoy W, Aranda D. A parent-based intervention to reduce sexual risk behavior in early adolescence: building alliances between physicians, social workers, and parents. J Adolesc Health. 2011 Feb;48(2):159-63. doi: 10.1016/j.jadohealth.2010.06.007.
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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
Columbia 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 Columbia 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 11 Jul 2013. 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 sexual intercourse measured (time frame: Measured at Months 3 and 12 post-treatment). 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 NCT00461487, 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 11 Jul 2013.