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PRIDE: Preventing Respiratory Illnesses During Childhood Study (PRIDE)

23. august 2017 opdateret af: Johns Hopkins University

A+ Head Start Intervention for Smoke Free Homes

Environmental tobacco smoke (ETS0, also known as secondhand smoke, is the combination of smoke given off by the burning end of a tobacco product and the smoke exhaled by the smoker. Children exposed to ETS are at an increased risk of sudden infant death syndrome (SIDS), ear infections, colds, pneumonia, bronchitis and more severe asthma. ETS can also slow the growth of children's lungs and can cause them to cough, wheeze and fell breathless. The purpose of this study is to determine the effectiveness of a motivational interviewing-based program in reducing ETS exposure and improving lung health among children who are enrolled in a Head Start program and whose households include a smoker.

Studieoversigt

Detaljeret beskrivelse

About 90% of nonsmoking people in the US are exposed to ETS. More than 50 chemicals identified in ETS have been found to cause cancer and exposure has been linked to heart disease in adults and SIDS, ear infections and numerous respiratory problems, including asthma in children. In 2007, the Environmental Protection Agency and the Office of Head Start-a national program that provides economically disadvantaged children services to enhance their social and cognitive development-announced a new initiative to promote smoke-free homes for children in Head Start programs. Because Head Start reaches high-risk, low-income preschool children, it offers a timely intervention for reducing children's exposure to ETS. Head Start also attempts to engage parents, which is an important component of reducing household ETS exposure among children. This study will determine the effectiveness of a home-delivered, motivational interviewing-based program in reducing ETS exposure and improving lung health among children who are enrolled in the Baltimore City Head Start program and whose households include a smoker.

Participation in this study will last 1 year. First, all participating families will be visited at home by a study staff person who will attach special filters that will track the amount of nicotine in the various rooms of the house. During this initial visit, the participating children will undergo weight and height measurements and saliva sampling. About a week later, the filters will be collected, a 2nd saliva samples will be taken and parents will be interviewed about their family and child's health. Families will then be randomly assigned to one of two groups. Both groups will received educational information about reducing tobacco smoke exposure. One group will also receive the home-delivered, motivational interviewing-based program aimed to reduce ETS. This program will consist of 2 home visits and 2 phone calls, both led by health counselor who will teach participants how to reduce their child's exposure to tobacco smoke. The home visits will occur during Weeks 1 & 2 and the phone calls will occur during Weeks 3 & 6. Follow-up visits for all participating families will occur at Months 3,6 and 12 and will involve repeat filter testing, saliva monitoring and interviews.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

350

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21206
        • Johns Hopkins University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 måneder til 6 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Child enrolled in Baltimore City Head Start
  • Smoker living in the home with child

Exclusion Criteria:

  • No smoker in home with child
  • Does not speak English
  • Is enrolled in other respiratory research study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Behavioral

Motivational Interviewing Intervention Plus Education

Caregivers will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.

The intervention is designed to motivate caregivers to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Caregivers will receive 2 home visits & 2 telephone session, both with a health counselor. Caregivers will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so.
Aktiv komparator: Education Only
Caregivers will receive only educational program for ETS reduction.
An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Air Nicotine Levels
Tidsramme: Measured at Baseline, 3, 6 and 12 months
Air nicotine levels were an indicator of child's exposure to environmental tobacco smoke (ETS)
Measured at Baseline, 3, 6 and 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ETS Reduction, as Measured by Child's Cotinine Levels
Tidsramme: Measured at Baseline, 3, 6 and 12 months
Child salivary cotinine will be a measure to evaluate environmental tobacco smoke (ETS) reduction
Measured at Baseline, 3, 6 and 12 months
Respiratory Function of Child by Self Report of Parent
Tidsramme: Measured at Baseline, 3, 6, and 12 months
Number of cold infections child experienced in previous 3 months, reported by caregiver
Measured at Baseline, 3, 6, and 12 months
Health Care Utilization by Child- Self Report From Parent/Caregiver
Tidsramme: Measured at baseline and 3, 6 and 12 months
Parent caregiver reported urgent care visits, number of hospitalizations, and number of emergency department visits in the 12 months prior for child enrolled in study
Measured at baseline and 3, 6 and 12 months
Number of Participants Who Report Endorsing a Home Smoking Ban
Tidsramme: Measured at baseline, 3, 6 and 12 months
Number of participants endorsing presence of home smoking ban
Measured at baseline, 3, 6 and 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Cynthia S Rand, PhD, Johns Hopkins University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2009

Primær færdiggørelse (Faktiske)

1. januar 2013

Studieafslutning (Faktiske)

1. juni 2013

Datoer for studieregistrering

Først indsendt

23. juni 2009

Først indsendt, der opfyldte QC-kriterier

23. juni 2009

Først opslået (Skøn)

24. juni 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. august 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. august 2017

Sidst verificeret

1. august 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 664
  • R18HL092901-01 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

We will not be sharing individual participant data

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Motivational Interviewing Intervention for ETS Reduction

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