HIV InfectionsPhase 1NCT00137943
Parents Matter!: Interventions to Promote Effective Parent-Child Communication
A Phase 1 study testing Full Parent communication intervention and Brief Parent Communication Intervention in people with HIV Infections and Sexually Transmitted Diseases, run by Centers for Disease Control and Prevention at 3 sites in United States.
Trial summary
Parents Matter is a community-based project whose goal it is to develop and test an intervention designed to promote effective parent-child communication about sexuality in order to promote sexual health among adolescents. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Diseases, Pregnancy
- What is being tested?
- Full Parent communication intervention and Brief Parent Communication Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,210 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 1999to Sep 2006
- Phase
- Phase 1
- 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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The eligibility criteria for the parent-child dyad are as follows:
- The parent or guardian must be African-American
- The parent or guardian must be the primary caregiver for a child in 4th or 5th grade who is 12 or younger at the time of the 1st assessment.
- The parent or guardian and the child must have lived together continuously for at least the past 3 years and the child must spend most nights (5 or more) with the parent or guardian.
- The parent or guardian and the child must both speak English.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Georgia
Athens, Georgia, 30602
Georgia State University
Atlanta, Georgia, 30303
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72202
About this study
Official title: Parents Matter!: Interventions to Promote Effective Parent-Child Communication About Sex and Sexual Risk Among African American Families
Parents Matter is a community-based project whose goal it is to develop and test an intervention designed to promote effective parent-child communication about sexuality in order to promote sexual health among adolescents.
Read the detailed description
Participants in the intervention are African American parents or guardians who have children in the 4th or 5th grade that are 12 or younger. Recruitment was done through schools, housing authorities, community based organizations, and churches. Participants were randomly assigned to participate in one of three interventions delivered by community based interventionists. The enhanced sexuality communication intervention consists of five 2.5 hour sessions conducted over 5 weeks with booster sessions at 12 and 24 months post-intervention. The full sexual communication intervention focuses on general parenting skills and sexual communication skills using a variety of presentation modalities: group discussion, video, and role-plays. The brief sexual communication intervention consists of a single 2.5 hour session in which parents are provided with information on general parenting skills and sexual communication skills. Thus, this intervention seeks to provide the same information as the full sexual communication intervention but in a condensed format with little group participation. The control intervention is a single 2.5 hour session focusing on general child health issues such as diet and exercise rather than parenting and sexual communication.
- Conditions
- HIV Infections, Sexually Transmitted Diseases, Pregnancy
- Being tested
- Full Parent communication intervention, Brief Parent Communication Intervention, Control Parent Intervention
- Keywords
- Parent-child communication, Primary prevention, sexual risk prevention, HIV
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Parent communication interventionBehavioural
Brief Parent Communication InterventionBehavioural
Control Parent InterventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of teens who have initiated sexual intercourse at 3 years post intervention
Secondary outcomes (4)
Increase in parental knowledge at 1 year
Increase in parental skills at 1 year
Increase in parental comfort communicating at 1 year
Increase in parental confidence communicating at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startSep 1999
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,210 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- University of Georgia
- Responsible party
- Sponsor
- Investigators
- Rex Forehand, Ph.D., Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137943
- Sponsor's protocol ID
- CDC-NCHSTP-2834
- Other IDs
- CCU417720
- Status last verified
- Sep 2012
- First submitted
- 26 Aug 2005
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Forehand R, Gound M, Kotchick BA, Armistead L, Long N, Miller KS. Sexual intentions of black preadolescents: associations with risk and adaptive behaviors. Perspect Sex Reprod Health. 2005 Mar;37(1):13-8. doi: 10.1363/psrh.37.13.05.
PubMed 15888398Forehand, R., Miller, K.S., Armistead, L., Kitchick, B.A., & Long, N. (2004). Parents Matter! Program: An Introduction. Journal of Child and Families Studies, 13, 1-3.
Dittus, P., Miller, K.S., Kotchick, B.A., & Forehand, R. (2004). Why parents matter: The conceptual basis for a community-based HIV prevention program prevention program for African American youth. Journal of Child and Family Studies, 13, 5-20.
Ball, J., Pelton, J., Forehand, R., Long, N., & Wallace, S. (2004). Methodological overview of the Parents Matter! Program St. Journal of Child and Family Studies, 13, 21-34.
Secrest, L.A., Lassiter, S.L., Armistead, L.P., Wyckoff, S.C., Johnson, J., Williams, W.B., & Kotchick, B.A. (2004). The Parents Matter! Program: Building a successful investigator community partnership. Journal of Child and Family Studies, 13, 35-45.
Long, N., Austin, B., Gound, M., Kelly, A., Gardner, A., Dunn, R., Harris, & Miller, K. (2004). The Parents Matter! Program Interventions: Content and the facilitation process. Journal of Child and Family Studies, 13, 47-65.
Armistead, L., Clark, H., Barber, N., Dorsey, S., Hughley, J., Favors, M., & Wycoff, S. (2004). Participant retention in the Parents Matter! Program: Strategies and outcomes. Journal of Child and Family Studies, 13, 67-80.
Murry, V.M., Kotchick, B.A., Wallace, S., Ketchen, B., Eddings, K., Heller, L., & Collier, I. (2004). Race, culture and ethnicity: Implications for a community intervention. Journal of Child and Family Studies, 13, 81-99.
Long, N., Miller, K.S., Jackson, L.C., Lindner, G.K., Hunt, R.G., Robinson, A.D., Goldsby, W.D., & Armistead, L.P. (2004). Lessons learned from the Parents Matter! Program. Journal of Child and Family Studies, 13, 101-112.
Forehand R, Armistead L, Long N, Wyckoff SC, Kotchick BA, Whitaker D, Shaffer A, Greenberg AE, Murry V, Jackson LC, Kelly A, McNair L, Dittus PJ, Lin CY, Miller KS. Efficacy of a parent-based sexual-risk prevention program for African American preadolescents: a randomized controlled trial. Arch Pediatr Adolesc Med. 2007 Dec;161(12):1123-9. doi: 10.1001/archpedi.161.12.1123.
PubMed 18056556
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents Matter!: Interventions to Promote Effective Parent-Child Communication About Sex and Sexual Risk Among African American Families
- ClinicalTrials.gov ID
- NCT00137943
- Acronym / sponsor ID
- CDC-NCHSTP-2834
- Conditions
- HIV Infections, Sexually Transmitted Diseases, Pregnancy
- Keywords
- Parent-child communication, Primary prevention, sexual risk prevention, HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,210 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- University of Georgia
- Study start
- Sep 1999
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 30 Aug 2005 (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.
Parents Matter is a community-based project whose goal it is to develop and test an intervention designed to promote effective parent-child communication about sexuality in order to promote sexual health among adolescents.
Detailed description
Participants in the intervention are African American parents or guardians who have children in the 4th or 5th grade that are 12 or younger. Recruitment was done through schools, housing authorities, community based organizations, and churches. Participants were randomly assigned to participate in one of three interventions delivered by community based interventionists. The enhanced sexuality communication intervention consists of five 2.5 hour sessions conducted over 5 weeks with booster sessions at 12 and 24 months post-intervention. The full sexual communication intervention focuses on general parenting skills and sexual communication skills using a variety of presentation modalities: group discussion, video, and role-plays. The brief sexual communication intervention consists of a single 2.5 hour session in which parents are provided with information on general parenting skills and sexual communication skills. Thus, this intervention seeks to provide the same information as the full sexual communication intervention but in a condensed format with little group participation. The control intervention is a single 2.5 hour session focusing on general child health issues such as diet and exercise rather than parenting and sexual communication.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The parent or guardian must be African-American
- The parent or guardian must be the primary caregiver for a child in 4th or 5th grade who is 12 or younger at the time of the 1st assessment.
- The parent or guardian and the child must have lived together continuously for at least the past 3 years and the child must spend most nights (5 or more) with the parent or guardian.
- The parent or guardian and the child must both speak English.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Full Parent communication intervention | Behavioural | – |
| Brief Parent Communication Intervention | Behavioural | – |
| Control Parent Intervention | Behavioural | – |
Primary outcome
Percent of teens who have initiated sexual intercourse at 3 years post intervention
4 secondary outcomes
Increase in parental knowledge at 1 year
Increase in parental skills at 1 year
Increase in parental comfort communicating at 1 year
Increase in parental confidence communicating at 1 year
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 Sep 2012.
- Background: PubMed 15888398Forehand R, Gound M, Kotchick BA, Armistead L, Long N, Miller KS. Sexual intentions of black preadolescents: associations with risk and adaptive behaviors. Perspect Sex Reprod Health. 2005 Mar;37(1):13-8. doi: 10.1363/psrh.37.13.05.
- BackgroundForehand, R., Miller, K.S., Armistead, L., Kitchick, B.A., & Long, N. (2004). Parents Matter! Program: An Introduction. Journal of Child and Families Studies, 13, 1-3.
- BackgroundDittus, P., Miller, K.S., Kotchick, B.A., & Forehand, R. (2004). Why parents matter: The conceptual basis for a community-based HIV prevention program prevention program for African American youth. Journal of Child and Family Studies, 13, 5-20.
- BackgroundBall, J., Pelton, J., Forehand, R., Long, N., & Wallace, S. (2004). Methodological overview of the Parents Matter! Program St. Journal of Child and Family Studies, 13, 21-34.
- BackgroundSecrest, L.A., Lassiter, S.L., Armistead, L.P., Wyckoff, S.C., Johnson, J., Williams, W.B., & Kotchick, B.A. (2004). The Parents Matter! Program: Building a successful investigator community partnership. Journal of Child and Family Studies, 13, 35-45.
- BackgroundLong, N., Austin, B., Gound, M., Kelly, A., Gardner, A., Dunn, R., Harris, & Miller, K. (2004). The Parents Matter! Program Interventions: Content and the facilitation process. Journal of Child and Family Studies, 13, 47-65.
- BackgroundArmistead, L., Clark, H., Barber, N., Dorsey, S., Hughley, J., Favors, M., & Wycoff, S. (2004). Participant retention in the Parents Matter! Program: Strategies and outcomes. Journal of Child and Family Studies, 13, 67-80.
- BackgroundMurry, V.M., Kotchick, B.A., Wallace, S., Ketchen, B., Eddings, K., Heller, L., & Collier, I. (2004). Race, culture and ethnicity: Implications for a community intervention. Journal of Child and Family Studies, 13, 81-99.
- BackgroundLong, N., Miller, K.S., Jackson, L.C., Lindner, G.K., Hunt, R.G., Robinson, A.D., Goldsby, W.D., & Armistead, L.P. (2004). Lessons learned from the Parents Matter! Program. Journal of Child and Family Studies, 13, 101-112.
- Derived from this study: PubMed 18056556Forehand R, Armistead L, Long N, Wyckoff SC, Kotchick BA, Whitaker D, Shaffer A, Greenberg AE, Murry V, Jackson LC, Kelly A, McNair L, Dittus PJ, Lin CY, Miller KS. Efficacy of a parent-based sexual-risk prevention program for African American preadolescents: a randomized controlled trial. Arch Pediatr Adolesc Med. 2007 Dec;161(12):1123-9. doi: 10.1001/archpedi.161.12.1123.
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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.
Rex Forehand, Ph.D. principal investigator
University of Vermont
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Full Parent communication intervention and Brief Parent Communication Intervention in people with HIV Infections and Sexually Transmitted Diseases, run by Centers for Disease Control and Prevention at 3 sites 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 5 inclusion and 0 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 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percent of teens who have initiated sexual intercourse at 3 years post intervention. 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 NCT00137943, which also lists 10 linked publications.
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 Sep 2012.