Study protocol for a randomized controlled trial of the Parent-Child Assistance Program: a case management and home visiting program for people using substances during pregnancy

Background Perinatal substance use can have significant adverse effects on maternal and child health and family stability. Few interventions are specifically designed to address this significant public health problem. The Parent-Child Assistance Program (PCAP) is a 3-year case management and home-visiting intervention that seeks to help birthing persons with at-risk substance use during pregnancy to achieve and maintain substance use disorder recovery and avoid exposing future children to substances prenatally. At-risk refers to a level of substance use that creates problems in the individuals' lives or puts them or their children at risk of harm either prenatally or postnatally. Although the program has consistently shown substantial pre- to post-intervention improvements in its participants, PCAP remains to be tested with a rigorous randomized controlled trial (RCT). This study protocol describes a randomized controlled trial that aims to examine the effectiveness of the intervention compared to services as usual in affecting primary outcomes related to substance use and family planning. Secondary outcomes will concern connection to recovery support services and family preservation.Methods Using an intent-to-treat design, the study will recruit from two metro areas in Oklahoma and enroll 200 birthing individuals who are pregnant or up to 24 months postpartum with at-risk substance use during their current or most recent pregnancy. Participants will be randomly assigned, stratified by location, to receive either PCAP or services as usual for 3 years. Participants in the PCAP condition will meet with their case manager approximately biweekly over the course of the intervention period, in their local communities or in their own homes whenever possible. Case managers will assist with goal setting and provide practical assistance in support of participants' goals. Primary and secondary outcomes will be assessed at baseline and 12, 24, and 36 months post-baseline using the Addiction Severity Index interview and a self-administered survey.Discussion Results from this trial will help to gauge the effectiveness of PCAP in improving parent and child well-being. Results will be reviewed by federal clearinghouses on home-visiting and foster care prevention to determine the strength of evidence of effectiveness with implications for federal financing of this program model at the state level.Trial registration ClinicalTrials.gov NCT05534568. Registered on 6/8/2022.