Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02557919
Other study ID # 13-0683
Secondary ID
Status Completed
Phase N/A
First received September 14, 2015
Last updated September 22, 2015
Start date September 2013
Est. completion date December 2014

Study information

Verified date September 2015
Source Harvard School of Public Health
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This project proposes to evaluate the effectiveness of training Head Start staff to discuss tobacco use, shs reduction and cessation in their existing encounters with parents in reducing tobacco use and exposure. Understanding the facilitators and barriers to integrating the intervention into the Head Start system will support future efforts to address tobacco use and exposure in families with small children.


Description:

Parental smoking increases children's risk of asthma, infectious illness, sudden infant death syndrome (SIDS), and other conditions. Accumulating evidence regarding the adverse effects of total smoke exposure (TSE) led the US Surgeon General to conclude that there is no safe level of TSE. Parents who smoke endanger themselves, put their children and spouses at risk for adverse health outcomes, and increase the chance of their children becoming smokers. However, many parents who smoke are undertreated for their tobacco addiction. Many parents who smoke are of the age where they have few contacts with primary care physicians and are often unexposed to counseling and pharmacotherapy offered to older patients. Strategically identifying sites where trained para-professionals routinely interact with parents who smoke is vital to making inroads in this high-risk population.

Involuntary secondhand smoke exposure (SHSe) in domestic environments is an entirely preventable public health threat that disproportionately burdens young children in communities of low socioeconomic position. Research has indicated that interventions to reduce SHSe for children delivered through child care settings have been effective. In addition, client-centered approaches, such as motivational interviewing, have been effective in helping parents to reduce levels of SHS in the home environment. Following guidelines from established agencies and organizations, we will also evaluate changes in smoking cessation rates among parents and staff comparing use prior to and after the training programs and subsequent family service worker to parent encounters.

Aim 1: Building on Action for Boston Community Development's (ABCD) current system efforts, support the development and implementation of system changes to accurately and efficiently document parental smoking and household tobacco use and exposure, using: i) intake form, ii) Individual Family Plan, and iii) electronic data system.

Aim 2: Collaborate with Legacy and University of Massachusetts (UMass) to train Head Start staff in skills for encouraging smoking cessation and on a smoke-free home intervention, to increase staff knowledge of second-hand smoke (SHS) effects and provide skills in Motivational Interviewing. This will enhance staff confidence in engaging with parents to assist in efforts to make a sustained quit attempt, reduce children's SHS exposure, and will provide structure to help staff determine how best to support families on issues of tobacco use, including referral to cessation services.

Aim 3: Evaluate the effectiveness of sites receiving the a) Motivational Interviewing intervention for family service workers, b) supervisor education, and c) boosters in decreasing parent smoking, reducing household tobacco use and children's SHS exposure, compared with sites receiving only basic tobacco information.

Aim 4: Evaluate the effectiveness of the smoking cessation intervention on the staff most intimately involved in parent counseling-namely, the family service workers who will attend the training program (s). We will evaluate their knowledge, attitudes, beliefs, and smoking practices as well as their confidence and skills in tobacco-related counseling.


Recruitment information / eligibility

Status Completed
Enrollment 225
Est. completion date December 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Parent Inclusion

1. Parent of a child enrolled in an ABCD Early Head Start/Head Start Program

2. Current smoker (1 or more cigarettes per day) and/or smoking is happening in or around (attached porches, patios, hallways) the family home by family members or regular visitors

3. Able to complete a self-administered survey or request assistance from research staff

4. Able to communicate in English or Spanish

Staff Inclusion

1. Staff member at one of the participating ABCD Head Start sites

2. Willing to consent to complete the staff survey

Exclusion Criteria:

- Parent Exclusion

1. Unable or unwilling to consent to participate in this research

2. No smoking is happening in or around the home

Staff Exclusion

1. Unwilling or unable to consent to complete the staff survey

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Motivational Interviewing Training
1.5 day training on Motivational Interviewing (MI) techniques plus 2 booster sessions to address real experiences using MI with families.
Usual Best Practice
.5 day training on tobacco control and emerging products.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Harvard School of Public Health Truth Initiative

Outcome

Type Measure Description Time frame Safety issue
Primary Tobacco quit attempts in the past 6 months (staff and parents) Parents and staff will be surveyed to determine the number of quit attempts in the past 6 months. Past 6 months No
Secondary Home smoking ban implemented in the past 6 months Parents will be surveyed to determine the number of home smoking bans implemented in the past 6 months. Past 6 months No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06021652 - Feasibility, Adoption and Efficacy of A Virtual Reality Smoking Cessation Program for Patients Undergoing Lung Cancer Screening N/A
Completed NCT02735382 - EHR-Based and Fax-Based Referral to a Tobacco Quitline: A Comparative Study N/A
Completed NCT01570595 - Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV Phase 1/Phase 2
Completed NCT00786149 - Improving Varenicline Adherence and Outcomes in Homeless Smokers Phase 3
Completed NCT00387946 - Efficacy and Safety of Dianicline Treatment as an Aid to Smoking Cessation in Cigarette Smokers (AMERIDIAN) Phase 3
Completed NCT00218452 - Smoking Cessation for Young Adults Who Binge Drink - 1 Phase 0
Completed NCT00124683 - Treating Nicotine Dependence in Schizophrenic Individuals: Effectiveness of Bupropion - 1 Phase 2
Recruiting NCT04610931 - Study of the Effectiveness of a Virtual Reality Treatment in the Management of Smoking Cessation N/A
Enrolling by invitation NCT06042361 - Enhancing Equity in Smoke-free Housing N/A
Recruiting NCT04827420 - Mi QUIT CARE (Mile Square QUIT Community-Access-Referral-Expansion) N/A
Recruiting NCT04994444 - Preloading With Nicotine Replacement Therapy in HIV-positive Smokers to Improve Self-Efficacy and Quit Attempts Phase 2/Phase 3
Completed NCT05560243 - Tobacco Cessation Tailored to Patients Living With HIV (PLWH) in Brazil N/A
Completed NCT02721082 - Changing the Default for Tobacco Treatment Phase 4
Completed NCT01885221 - A Multi-Media Approach to Partner Support in Smokeless Tobacco Cessation (UCare-ChewFree) N/A
Completed NCT03445507 - Effectiveness of a Chat Bot for Smoking Cessation: a Pragmatic Trial in Primary Care. N/A
Completed NCT04540081 - Enhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer N/A
Completed NCT03714191 - Optimizing the Tobacco Cessation Clinical Decision Support Tool.
Completed NCT03553992 - An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers N/A
Completed NCT01699828 - Exploring Occupancy of Dopamine D3 Receptor by Buspirone in Humans Using PET Phase 1/Phase 2
Completed NCT01328431 - Treating Low-Income Smokers in the Hospital Emergency Department N/A