NCT02557919

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

9 months

First QC Date

September 14, 2015

Last Update Submit

September 22, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Home smoking ban implemented in the past 6 months

    Past 6 months

Study Arms (2)

Motivational Interviewing Training

EXPERIMENTAL

Staff at the intervention sites were trained in basic tobacco control and motivational interviewing. Two booster trainings were held over 6 months.

Other: Motivational Interviewing Training

Usual Best Practice

OTHER

Staff at the usual best practice sites received basic tobacco control training.

Other: Usual Best Practice

Interventions

1.5 day training on Motivational Interviewing (MI) techniques plus 2 booster sessions to address real experiences using MI with families.

Motivational Interviewing Training

.5 day training on tobacco control and emerging products.

Usual Best Practice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parent of a child enrolled in an ABCD Early Head Start/Head Start Program
  • 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
  • Able to complete a self-administered survey or request assistance from research staff
  • Able to communicate in English or Spanish
  • Staff member at one of the participating ABCD Head Start sites
  • Willing to consent to complete the staff survey

You may not qualify if:

  • Unable or unwilling to consent to participate in this research
  • No smoking is happening in or around the home
  • \. Unwilling or unable to consent to complete the staff survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Alan C Geller, RN, MPH

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

September 14, 2015

First Posted

September 23, 2015

Study Start

September 1, 2013

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

September 23, 2015

Record last verified: 2015-09