Health Care Decisions for Female Adolescents: The Role of Mothers and Daughters in Decision Making

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University of Louisville
ClinicalTrials.gov Identifier:
NCT00807898
First received: December 11, 2008
Last updated: January 28, 2011
Last verified: January 2011
  Purpose

Preventing cervical cancer is a public health concern. Since 2006 a quadrivalent vaccine for young women nine to twenty six years of age has been available to protect against the human papillomavirus (HPV) and to prevent some types of cervical cancer (Gardasil). The vaccine is an important health promotion tool to address the widespread prevalence of HPV and cervical cancer, but not all eligible young women receive the vaccine. The vaccine is most effective when administered to young women before their sexual debut. When the vaccine is given to young women less than 18 years of age, parental permission is required. This permission is usually provided by the young woman's mother. Understanding predictors of a mother's decision for her minor daughter to receive the HPV vaccine will inform interventions that seek to increase the number of young women who receive the vaccine.

The study will focus on mothers and their adolescent daughters between 13-17 years of age. We hypothesize that the Expanded Theory of Planned Behavior will explain a mother's decision to choose the HPV vaccine for her daughter.

Research Questions include: 1)What TPB variables predict a mother's decision to choose HPV vaccine for her daughter? 2)What variables predict the strength of a daughter's influence on the mother's decision to choose HPV vaccine for her daughter? 3) What are the relationships between the mothers' and daughters' scores on the variables related to the decision to choose HPV vaccine? 4) How do the mothers and daughters who chose to receive the HPV vaccine differ descriptively from those mothers and daughters who do not choose to receive the HPV vaccine?


Condition
Cervical Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Health Care Decisions for Female Adolescents: The Role of Mothers and Daughters in Decision Making

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Estimated Enrollment: 150
Study Start Date: January 2009
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Preventing cervical cancer is a public health concern. Since 2006 a quadrivalent vaccine for young women nine to twenty six years of age has been available to protect against the human papillomavirus (HPV) and to prevent some types of cervical cancer (Gardasil). The vaccine is an important health promotion tool to address the widespread prevalence of HPV and cervical cancer, but not all eligible young women receive the vaccine. The vaccine is most effective when administered to young women before their sexual debut. When the vaccine is given to young women less than 18 years of age, parental permission is required. This permission is usually provided by the young woman's mother. Understanding predictors of a mother's decision for her minor daughter to receive the HPV vaccine will inform interventions that seek to increase the number of young women who receive the vaccine.

Health behavior theories, such as the Theory of Planned Behavior (TPB), indicate the factors and mechanisms that predict health promotion decisions and activities. TPB provides a direct statistical model through which variables related to health behaviors can be measured and evaluated, and will be used to guide the proposed study.

The study will focus on mothers and their adolescent daughters between 13-17 years of age. The normative changes and realignments in the parent child relationship that arrive with the onset of adolescence, coincide with greater adolescence behavioral autonomy, and influence over parental decisions related to the adolescent. Thus, we expanded the TPB to include the influence of the adolescent on the mother's decision for her daughter to receive the HPV vaccine.

Hypothesis: We hypothesize that the Expanded Theory of Planned Behavior will explain a mother's decision to choose the HPV vaccine for her daughter.

Research Questions:

RSQ1: What TPB variables predict a mother's decision to choose HPV vaccine for her daughter?

RSQ2: What variables predict the strength of a daughter's influence on the mother's decision to choose HPV vaccine for her daughter?

RSQ3: What are the relationships between the mothers' and daughters' scores on the variables related to the decision to choose HPV vaccine?

RSQ4: How do the mothers and daughters who chose to receive the HPV vaccine differ descriptively from those mothers and daughters who do not choose to receive the HPV vaccine?

Data will be analyzed using path analysis, multiple regression, and analysis of variance. The model demonstrates multiple potential influences on the mother's decision to choose the HPV vaccine for her daughter, and all influences are potential targets for family teaching interventions and tailored social marketing. Further study will be needed to determine how well the model applies to various family types and diverse cultures and nationalities.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Mother and daughter pairs (n =75) will be recruited.

Criteria

Inclusion Criteria:

  • Adolescent females 13-17 years of age
  • and adolescent's mother, any age
  • and adolescent not pregnant
  • and adolescent has not received vaccine for HPV

Exclusion Criteria:

  • Males
  • daughters younger than 13 yrs of age
  • daughters older than 17 yrs of age
  • pregnant daughters
  • daughters who have received the HPV vaccine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807898

Locations
United States, Kentucky
University of Louisville School of Nursing
Louisville, Kentucky, United States, 40292
Sponsors and Collaborators
University of Louisville
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Mimia C Logsdon, DNS, ARNP, FAAN University of Louisville School of Nursing
  More Information

No publications provided by University of Louisville

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mimia Cynthia Logsdon, DNS, ARNP, FAAN, Professor, Principal Investigator, University of Louisville School of Nursing
ClinicalTrials.gov Identifier: NCT00807898     History of Changes
Other Study ID Numbers: OICB080587, Merck33563
Study First Received: December 11, 2008
Last Updated: January 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:
Gardasil
HPV vaccine
decision making
mother
daughter

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 16, 2014