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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00137943
Other study ID # CDC-NCHSTP-2834
Secondary ID CCU417720
Status Completed
Phase Phase 1
First received August 26, 2005
Last updated September 26, 2012
Start date September 1999
Est. completion date September 2006

Study information

Verified date September 2012
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2210
Est. completion date September 2006
Est. primary completion date September 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 9 Years to 12 Years
Eligibility Inclusion Criteria:

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
Full Parent communication intervention

Brief Parent Communication Intervention

Control Parent Intervention


Locations

Country Name City State
United States University of Georgia Athens Georgia
United States Georgia State University Atlanta Georgia
United States University of Arkansas for Medical Sciences Little Rock Arkansas

Sponsors (2)

Lead Sponsor Collaborator
Centers for Disease Control and Prevention University of Georgia

Country where clinical trial is conducted

United States, 

References & Publications (9)

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.

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.

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.

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. — View Citation

Forehand, 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.

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.

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.

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.

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.

Outcome

Type Measure Description Time frame Safety issue
Primary Percent of teens who have initiated sexual intercourse at 3 years post intervention
Secondary Increase in parental knowledge at 1 year
Secondary Increase in parental skills at 1 year
Secondary Increase in parental comfort communicating at 1 year
Secondary Increase in parental confidence communicating at 1 year
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