Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: En Pareja: A Latino Couples Intervention to Help Expectant Fathers Quit Smoking
Brief Summary: Smoking among Latino males living in the U.S. is a significant public health problem, one that can contribute to disparities in life expectancy and increase mortality. Latinos smoke at the same rate as White males but are less likely than Whites to quit. Interventions do not reach Latino smokers because many speak only Spanish and previous interventions have had notable limitations. First, most have recruited volunteers, so hard-to-reach Latino smokers likely did not participate. Second, cessation effects were short-term only. Third, no program has attempted to boost Latino cessation rates by capitalizing on a "teachable moment", a time when quitting may seem especially relevant. To address these deficits, we propose to conduct a teachable moment intervention trial for Latino smokers. We will attempt to capitalize on the potential teachable moment of Latinas' pregnancy as an impetus for Latinos' cessation. We will include couples, rather than just men, to sustain intervention effects. We will partner with community leaders to develop an intervention based primarily on Social Cognitive Theory, the Teachable Moment Model, and the Cognitive-Behavioral Couple Therapy Model. Some elements will be at the individual level to help Latinos quit smoking and others will be couple-based to improve communication and reduce stress in the postpartum relationship. The program will be culturally sensitive to Latino values, such as familismo, valuing of and duty to the family and personalismo, valuing warm personal relationships. We will recruit Latino couples (n=366) into a Guia (control) arm in which men receive a culturally appropriate smoking cessation guide, and a couple-based smoking cessation counseling arm.

Hypothesis 1: Latino expectant fathers who receive couple-based counseling to quit smoking will be more likely to be abstinent from smoking at 28 weeks in pregnancy and 12 months post-randomization than Latino expectant fathers who receive a self-help smoking cessation guide.

Hypothesis 2: Couple-based counseling will improve mediators, such as couple communication about smoking, self-efficacy, outcome expectancies, stress levels, risk perceptions, emotion, and self-image, which in turn, will increase cessation rates among Latino expectant fathers.

Hypothesis 3: Couples in the counseling arm will have a greater increase in cessation during pregnancy and a lower decrease in cessation at 6 and 12 months post-randomization than couples in the Guia arm.


Options:
A: Arm Label: a self help smoking cessation guide; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Guia -a self help smoking cessation guide | Arm Label: couple-based counseling for smoking cessation plus Guia; Type: EXPERIMENTAL; Interventions: Behavioral: couple-based counseling for smoking cessation plus self-help smoking cessation guide | Intervention Type: BEHAVIORAL; Name: couple-based counseling for smoking cessation plus self-help smoking cessation guide; Assigned to Arm(s): couple-based counseling for smoking cessation plus Guia | Intervention Type: BEHAVIORAL; Name: Guia -a self help smoking cessation guide; Assigned to Arm(s): a self help smoking cessation guide
B: Arm Label: High intensity intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Higher intensity intervention | Arm Label: Low intensity intervention; Type: OTHER; Interventions: Behavioral: Low intensity intervention | Intervention Type: BEHAVIORAL; Name: Low intensity intervention; Assigned to Arm(s): Low intensity intervention | Intervention Type: BEHAVIORAL; Name: Higher intensity intervention; Assigned to Arm(s): High intensity intervention
C: Arm Label: A; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Arm Label: B; Type: EXPERIMENTAL; Interventions: Drug: 2 mg nicotine polacrilex | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): A | Intervention Type: DRUG; Name: 2 mg nicotine polacrilex; Assigned to Arm(s): B
D: Intervention Type: BEHAVIORAL; Name: Nicotine Replacement Therapy; Assigned to Arm(s): N/A

Answer: A