Family Preventive Visits to Detect Risk Factors in the Family

Family Clinical Trial

Official title:

Family Preventive Visits to Detect Risk Factors in the Family

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269086
• Other study ID #: 00001
• Status: Completed
• Phase: N/A
• First received: December 30, 2010
• Last updated: May 26, 2011
• Start date: September 2010
• Est. completion date: May 2011

Study information

• Verified date: October 2010
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Pontificia Universidad Catolica de Chile School of Medicine
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a systematic family assessment in adult preventive health visits increases the detection of risk factors in the spouse or adolescent child of the screened person.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Parents of adolescents between 14-17 years.

Exclusion Criteria:

• Living with single parents.

• Does not accept participating in the study.

Study Design

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

Related Conditions & MeSH terms

• Adolescent Health Services
• Family
• Family Practice
• Preventive Medicine
• Primary Heath Care

Intervention

Behavioral:
• Family Preventive Visit
Systematic assessment of health diseases or risk factors in the spouse and adolescent child.

Locations

Country	Name	City	State
Chile	Centro de Salud Familiar San Alberto Hurtado	Santiago

Sponsors (3)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile	Fundacion Hispanoamericana de Solidaridad, Fundacion MAPFRE

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite outcome: Family Risk Factors	The composite outcome is conformed by: detection of smoking, alcohol, substance abuse, major depression or other mental health disease, high emotional stress, suicide risk in the couple and the adolescent child; and risk of pregnancy, risk of sexually transmitted diseases, risk of eating disorders, risk of school grade repetition or school drop-out in the adolescent child, and the presence of marital or parent-child relationship problems detected by the parent/spouse.	1 month	No
Secondary	Composite outcome: Couple Risk Factors	The composite outcome is conformed by: detection of smoking, alcohol, substance abuse, major depression or other mental health disease, high emotional stress, suicide risk in the couple, and the presence of marital relationship problems detected by the spouse.	1 month	No
Secondary	Composite outcome: Adolescent Risk Factors	The composite outcome is conformed by: smoking, alcohol, substance abuse, major depression or other mental health disease, high emotional stress, risk of suicide, risk of pregnancy, risk of sexually transmitted diseases, risk of eating disorders, risk of school grade repetition or school drop-out in the adolescent child, and the presence of parent-child relationship problems detected by the parent.	1 month	No
Secondary	Type of health plan for follow up	The health plan will be categorized in comprehensive bio-psycho-social health plans or only biomedical health plans.	1 month	No
Secondary	Diagnostic accuracy of adults to diagnose risk factors in their spouse or adolescent child.	We will assess sensibility, specificity, positive and negative predictive values, positive and negative likelihood ratios of parents to detect risk factors in their spouse and child.	1 month	No