Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06591026
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Helpline Pilot Factorial Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Helpline Delivery of Brief Interventions for Postpartum Heavy Episodic Drinking
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The pilot factorial trial will 1 evaluate feasibility acceptability and fidelity of the intervention components Aim 21 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 22 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 21 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 22 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None