Heavy DrinkingNCT06591026
Helpline Pilot Factorial Trial
A study testing Standard Helpline (SH), Motivational Interviewing (MI) and Coping Skills Training (CST) in people with Heavy Drinking, run by The National Center on Addiction and Substance Abuse at Columbia University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Heavy Drinking
- What is being tested?
- Standard Helpline (SH), Motivational Interviewing (MI) and Coping Skills Training (CST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Resides full-time in the United States
- Age 18-45 years
- Gave birth to an infant within the prior 4 weeks
- Speaks and reads English
- Owns a text-enabled cell-phone
- Receives a score of 2 or more on the T-ACE alcohol risk screener
- Reports ONE of the following: (a) drinking weekly or more often in the prior month; or (b) having 4 or more standard drinks at one time at least monthly in the 12 months prior to becoming pregnant.
Who cannot join
- Resides outside of the United States
- Age under 18 years or over 45 years
- Did not give birth to an infant within the prior 4 weeks
- Cannot speak and read English
- Does not own a text-enabled cell-phone
- Does not receive a score of at least 2 on the T-ACE alcohol risk screener
- Does not report either drinking weekly or more often in the past month or having 4 or more standard drinks at least monthly in the 12 months prior to becoming pregnant
- Scores greater than 4 on the AUDIT-C, indicating an alcohol use disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Partnership to End Addiction
New York, New York, 10017
Sarah E Dauber, PhD, 212-841-5270, sdauber@toendaddiction.org
Sarah E Dauber, PhD
About this study
Official title: Helpline Delivery of Brief Interventions for Postpartum Heavy Episodic Drinking
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.
Read the detailed description
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.
- Conditions
- Heavy Drinking
- Being tested
- Standard Helpline (SH), Motivational Interviewing (MI), Coping Skills Training (CST), Automated Text Messaging (ATM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Helpline (SH)Behavioural
One digital helpline session that includes assessment, psychoeducation, and links to resources. Participants are also offered ongoing asynchronous digital support from the helpline.
Motivational Interviewing (MI)Behavioural
One digital helpline session that includes a structured motivational interviewing brief intervention.
Coping Skills Training (CST)Behavioural
One digital helpline session that includes a structured cognitive coping skills brief intervention.
Automated Text Messaging (ATM)Behavioural
Automated text messages are sent daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SH Only | Active comparator | Participants receive standard helpline component only Receives: Behavioral: Standard Helpline (SH) |
| SH+CST | Experimental | Participants receive the standard helpline component and the cognitive coping skills component. Receives: Behavioral: Standard Helpline (SH); Behavioral: Coping Skills Training (CST) |
| SH+ATM | Experimental | Participants receive the standard helpline component and the automated messaging component. Receives: Behavioral: Standard Helpline (SH); Behavioral: Automated Text Messaging (ATM) |
| SH+CST+ATM | Experimental | Participants receive the standard helpline component, the cognitive coping skills component, and the automated messaging component. Receives: Behavioral: Standard Helpline (SH); Behavioral: Coping Skills Training (CST); Behavioral: Automated Text Messaging (ATM) |
| SH+MI | Experimental | Participants receive the standard helpline component and the motivational interviewing component. Receives: Behavioral: Standard Helpline (SH); Behavioral: Motivational Interviewing (MI) |
| SH+MI+CST | Experimental | Participants receive the standard helpline component, the motivational interviewing component, and the cognitive coping skills component. Receives: Behavioral: Standard Helpline (SH); Behavioral: Motivational Interviewing (MI); Behavioral: Coping Skills Training (CST) |
| SH+MI+ATM | Experimental | Participants receive the standard helpline component, the motivational interviewing component, and the automated messaging component. Receives: Behavioral: Standard Helpline (SH); Behavioral: Motivational Interviewing (MI); Behavioral: Automated Text Messaging (ATM) |
| SH+MI+CST+ATM | Experimental | Participants receive the standard helpline component, the motivational interviewing component, the coping skills component, and the automated messaging component. Receives: Behavioral: Standard Helpline (SH); Behavioral: Motivational Interviewing (MI); Behavioral: Coping Skills Training (CST); Behavioral: Automated Text Messaging (ATM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heavy episodic drinking
Number of episodes of heavy episodic drinking, measured by the Timeline Follow Back.
Measured: 3-month follow-up; 6-month follow-up
Secondary outcomes (4)
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.
Measured: 3-month follow-up; 6-month follow-up
Drinking self-efficacy
Total score on the Drinking Refusal Self-Efficacy Questionnaire.
Measured: 3-month follow-up; 6-month follow-up
Maternal self-efficacy
Total score on the Karitane Parenting Confidence Scale.
Measured: 3-month follow-up; 6-month follow-up
Self-regulation
Total score on the Coping Self-Efficacy Scale.
Measured: 3-month follow-up; 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jun 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The National Center on Addiction and Substance Abuse at Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Dauber, The National Center on Addiction and Substance Abuse at Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591026
- Sponsor's protocol ID
- Helpline R34
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helpline Delivery of Brief Interventions for Postpartum Heavy Episodic Drinking
- ClinicalTrials.gov ID
- NCT06591026
- Acronym / sponsor ID
- Helpline R34
- Conditions
- Heavy Drinking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The National Center on Addiction and Substance Abuse at Columbia UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| SH Only | Active comparator | Behavioral: Standard Helpline (SH)Participants receive standard helpline component only |
| SH+CST | Experimental | Behavioral: Standard Helpline (SH), Behavioral: Coping Skills Training (CST)Participants receive the standard helpline component and the cognitive coping skills component. |
| SH+ATM | Experimental | Behavioral: Standard Helpline (SH), Behavioral: Automated Text Messaging (ATM)Participants receive the standard helpline component and the automated messaging component. |
| SH+CST+ATM | Experimental | Behavioral: Standard Helpline (SH), Behavioral: Coping Skills Training (CST), Behavioral: Automated Text Messaging (ATM)Participants receive the standard helpline component, the cognitive coping skills component, and the automated messaging component. |
| SH+MI | Experimental | Behavioral: Standard Helpline (SH), Behavioral: Motivational Interviewing (MI)Participants receive the standard helpline component and the motivational interviewing component. |
| SH+MI+CST | Experimental | Behavioral: Standard Helpline (SH), Behavioral: Motivational Interviewing (MI), Behavioral: Coping Skills Training (CST)Participants receive the standard helpline component, the motivational interviewing component, and the cognitive coping skills component. |
| SH+MI+ATM | Experimental | Behavioral: Standard Helpline (SH), Behavioral: Motivational Interviewing (MI), Behavioral: Automated Text Messaging (ATM)Participants receive the standard helpline component, the motivational interviewing component, and the automated messaging component. |
| SH+MI+CST+ATM | Experimental | Behavioral: Standard Helpline (SH), Behavioral: Motivational Interviewing (MI), Behavioral: Coping Skills Training (CST), Behavioral: Automated Text Messaging (ATM)Participants receive the standard helpline component, the motivational interviewing component, the coping skills component, and the automated messaging component. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Resides full-time in the United States
- Age 18-45 years
- Gave birth to an infant within the prior 4 weeks
- Speaks and reads English
- Owns a text-enabled cell-phone
Key exclusion criteria (8 listed)
- Resides outside of the United States
- Age under 18 years or over 45 years
- Did not give birth to an infant within the prior 4 weeks
- Cannot speak and read English
- Does not own a text-enabled cell-phone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Helpline (SH)One digital helpline session that includes assessment, psychoeducation, and links to resources. Participants are also offered ongoing asynchronous digital support from the helpline. | Behavioural | SH Only, SH+ATM, SH+CST, SH+CST+ATM, SH+MI, SH+MI+ATM, SH+MI+CST, SH+MI+CST+ATM |
| Motivational Interviewing (MI)One digital helpline session that includes a structured motivational interviewing brief intervention. | Behavioural | SH+MI, SH+MI+ATM, SH+MI+CST, SH+MI+CST+ATM |
| Coping Skills Training (CST)One digital helpline session that includes a structured cognitive coping skills brief intervention. | Behavioural | SH+CST, SH+CST+ATM, SH+MI+CST, SH+MI+CST+ATM |
| Automated Text Messaging (ATM)Automated text messages are sent daily for 4 weeks. | Behavioural | SH+ATM, SH+CST+ATM, SH+MI+ATM, SH+MI+CST+ATM |
Primary outcome
Heavy episodic drinking
Time frame: 3-month follow-up; 6-month follow-up
Number of episodes of heavy episodic drinking, measured by the Timeline Follow Back.
4 secondary outcomes
Motivation to avoid alcohol
Time frame: 3-month follow-up; 6-month follow-up
Drinking self-efficacy
Time frame: 3-month follow-up; 6-month follow-up
Maternal self-efficacy
Time frame: 3-month follow-up; 6-month follow-up
Self-regulation
Time frame: 3-month follow-up; 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Helpline (SH), Motivational Interviewing (MI) and Coping Skills Training (CST) in people with Heavy Drinking, run by The National Center on Addiction and Substance Abuse at Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Dauber, PhD (212-841-5270, sdauber@toendaddiction.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heavy episodic drinking (time frame: 3-month follow-up; 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.