The protocol for a pilot feasibility trial of Improving Neurodevelopmental ouTcomes After prenatal Cannabinoid in uTero exposure (INTACT) study for a multi-center trial

• DOI: 10.1371/journal.pone.0322035
• Publication Date: 2025-05-12T17:53:59Z
• Authors: Jessie R. Maxwell; Leigh-Anne Cioffredi; Maria M. Talavera...; Matthew Henry; Sandra Beauman; Anne Hittson; Meggie McCoy; Laurie Chassereau; Jing Jin; Preetha A. Abraham; Linda Y. Fu; Hengameh Raissy; Jessica N. Snowden

Background Legalization of recreational cannabis use is expanding across the United States, and prenatal has steadily increased. Evidence suggests that many pregnant individuals to relieve symptoms like nausea. Research demonstrated an association between cannabinoid exposure infant deficits in attention, planning, memory. In other high-risk populations, interventions aimed at increasing parental responsiveness have improved cognitive functioning children. This pilot trial aims utilize a contingent responding training program birthing parent-infant dyads with assess feasibility recruitment, completion proposed intervention adherence. Methods study will enroll post-partum parents who used products during pregnancy three clinical sites. After consenting confirming eligibility, be oriented online Play Learning Strategies (ePALS) by team member, after which they complete asynchronous monthly modules for 12 months highlight aspects responding. Study staff each site trained as coaches, meeting parent review reinforce areas focus. The primary objectives focus on ability recruit eligible caregivers pregnancy, retain participants duration measured through session when child age, overall participant adherence sessions. Discussion As becomes more prevalent, it critical we can provide optimize developmental outcomes. focused adapting proven populations determine if applied this population. If successful, future would efficacy following exposure. Trial registration Clinicaltrials.gov NCT 06423664 .