Helpline Pilot Factorial Trial
ConditionHeavy Drinking
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorThe National Center on Addiction and Substance Abuse at Columbia University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Factorial
Treatments tested in this trial
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.
Motivational Interviewing (MI)
BehavioralOne digital helpline session that includes a structured motivational interviewing brief intervention.
Coping Skills Training (CST)
BehavioralOne digital helpline session that includes a structured cognitive coping skills brief intervention.
Automated Text Messaging (ATM)
BehavioralAutomated text messages are sent daily for 4 weeks.
Treatment groups
120 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: SH OnlyActive comparator 1 intervention
Group B: SH+CSTExperimental treatment 2 interventions
Group C: SH+ATMExperimental treatment 2 interventions
Group D: SH+CST+ATMExperimental treatment 3 interventions
Group E: SH+MIExperimental treatment 2 interventions
Group F: SH+MI+CSTExperimental treatment 3 interventions
Group G: SH+MI+ATMExperimental treatment 3 interventions
Group H: SH+MI+CST+ATMExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Heavy episodic drinking
Number of episodes of heavy episodic drinking, measured by the Timeline Follow Back.
Time frame
3-month follow-up; 6-month follow-upSecondary outcomes
1
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.
Time frame
3-month follow-up; 6-month follow-up2
Drinking self-efficacy
Total score on the Drinking Refusal Self-Efficacy Questionnaire.
Time frame
3-month follow-up; 6-month follow-up3
Maternal self-efficacy
Total score on the Karitane Parenting Confidence Scale.
Time frame
3-month follow-up; 6-month follow-up4
Self-regulation
Total score on the Coping Self-Efficacy Scale.
Time frame
3-month follow-up; 6-month follow-upLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: