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The pilot factorial trial will (1) evaluate feasibility, acceptability, and fidelity of the intervention components (Aim 2.1), and (2) collect proof-of-concept data on the impact of the components on the proximal (motivation, self-efficacy, and self-regulation) and distal (quantity and frequency of HED) outcomes (Aim 2.2). Participants will include 120 postpartum mothers recruited from social media. The investigators will conduct a pilot 2X2X2 balanced full factorial trial, with 4 factors (1 constant, 3 randomized to 2 levels each) and 8 study conditions. The 4 factors will include: (1) Standard Helpline (constant); (2) Motivational Interviewing (yes vs. no); (3) Coping skills training (yes vs. no); (4) Automated messaging (yes vs. no). Participants will be randomly assigned to one of 8 study conditions, which will determine which combination of intervention components participants receive.
The pilot factorial trial will (1) evaluate feasibility, acceptability, and fidelity of the intervention components (Aim 2.1), and (2) collect proof-of-concept data on the impact of the components on the proximal (motivation, self-efficacy, and self-regulation) and distal (quantity and frequency of HED) outcomes (Aim 2.2). In keeping with the goals of the R34 mechanism, the emphasis will be on feasibility evaluation and not on hypothesis testing, with a goal of obtaining preliminary information about implementation feasibility and effect sizes of the intervention components to inform a fully-powered optimization trial in a future R01. Thus, investigators will examine main and interactive effects of the intervention components in an exploratory manner to inform refining the components for further testing in a future study. Participants will include 120 postpartum mothers recruited from social media. The investigators will conduct a pilot 2X2X2 balanced full factorial trial, with 4 factors (1 constant, 3 randomized to 2 levels each) and 8 study conditions. The 4 factors will include: (1) Standard Helpline (constant); (2) Motivational Interviewing (yes vs. no); (3) Coping skills training (yes vs. no); (4) Automated messaging (yes vs. no). Participants will be randomly assigned to one of 8 study conditions, which will determine which combination of intervention components participants receive. The study will last for 24 weeks. Following informed consent, participants will complete a baseline assessment and randomization, at which point participants will be enrolled. The active intervention period will begin in Week 2, with the number of scheduled sessions varying by condition. Participants will complete a post-intervention assessment and qualitative interview after the final intervention contact (varying by condition), and follow-up assessments at 3- and 6-months post-baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SH Only | Active Comparator | Participants receive standard helpline component only |
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| SH+CST | Experimental | Participants receive the standard helpline component and the cognitive coping skills component. |
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| SH+ATM | Experimental | Participants receive the standard helpline component and the automated messaging component. |
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| SH+CST+ATM | Experimental | Participants receive the standard helpline component, the cognitive coping skills component, and the automated messaging component. |
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| SH+MI | Experimental | Participants receive the standard helpline component and the motivational interviewing component. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Helpline (SH) | Behavioral | One digital helpline session that includes assessment, psychoeducation, and links to resources. Participants are also offered ongoing asynchronous digital support from the helpline. |
| Measure | Description | Time Frame |
|---|---|---|
| Heavy episodic drinking | Number of episodes of heavy episodic drinking, measured by the Timeline Follow Back. | 3-month follow-up; 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Motivation to avoid alcohol | Motivation to avoid alcohol use until the baby is one year old, assessed via the Maternal Motivation Scale. Likert scale 1-10. | 3-month follow-up; 6-month follow-up |
| Drinking self-efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Dauber, PhD | Contact | 212-841-5270 | sdauber@toendaddiction.org |
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All data from the factorial trial will be shared via the NIAAA Data Archive, in accordance with NIAAA's requirements for data sharing. No identifying information on participants will be shared.
In accordance with NIAAA recommendations, data will be deposited every 6 months until data collection is complete. Data will be available for as long as the NIAAA Data Archive allows.
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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| SH+MI+CST | Experimental | Participants receive the standard helpline component, the motivational interviewing component, and the cognitive coping skills component. |
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| SH+MI+ATM | Experimental | Participants receive the standard helpline component, the motivational interviewing component, and the automated messaging component. |
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| SH+MI+CST+ATM | Experimental | Participants receive the standard helpline component, the motivational interviewing component, the coping skills component, and the automated messaging component. |
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| Motivational Interviewing (MI) | Behavioral | One digital helpline session that includes a structured motivational interviewing brief intervention. |
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| Coping Skills Training (CST) | Behavioral | One digital helpline session that includes a structured cognitive coping skills brief intervention. |
|
| Automated Text Messaging (ATM) | Behavioral | Automated text messages are sent daily for 4 weeks. |
|
Total score on the Drinking Refusal Self-Efficacy Questionnaire.
| 3-month follow-up; 6-month follow-up |
| Maternal self-efficacy | Total score on the Karitane Parenting Confidence Scale. | 3-month follow-up; 6-month follow-up |
| Self-regulation | Total score on the Coping Self-Efficacy Scale. | 3-month follow-up; 6-month follow-up |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |