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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01269086
Other study ID # 00001
Secondary ID
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


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
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