Standard Helpline (SH)
BehavioralOne digital helpline session that includes assessment, psychoeducation, and links to resources. Participants are also offered ongoing asynchronous digital support from the helpline.
NCT Number: NCT06591026
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.
Trial opening soon.
Get Notified18 year–45 year
Female
Interventional
Phase 1
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One digital helpline session that includes assessment, psychoeducation, and links to resources. Participants are also offered ongoing asynchronous digital support from the helpline.
One digital helpline session that includes a structured motivational interviewing brief intervention.
One digital helpline session that includes a structured cognitive coping skills brief intervention.
Automated text messages are sent daily for 4 weeks.
Time frame: 3-month follow-up; 6-month follow-up
Number of episodes of heavy episodic drinking, measured by the Timeline Follow Back.
Time frame: 3-month follow-up; 6-month follow-up
Motivation to avoid alcohol use until the baby is one year old, assessed via the Maternal Motivation Scale. Likert scale 1-10.
Time frame: 3-month follow-up; 6-month follow-up
Total score on the Drinking Refusal Self-Efficacy Questionnaire.
Time frame: 3-month follow-up; 6-month follow-up
Total score on the Karitane Parenting Confidence Scale.
Time frame: 3-month follow-up; 6-month follow-up
Total score on the Coping Self-Efficacy Scale.
Contact information is provided by the study sponsor or research team.
The National Center on Addiction and Substance Abuse at Columbia University
Other
Helpline Delivery of Brief Interventions for Postpartum Heavy Episodic Drinking
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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