An interventional study of Play and Learn Strategies (PALS) Program in Developmental Delay, sponsored by IDeA States Pediatric Clinical Trials Network. Recruiting at 3 sites in United States. Open to participants aged Up to 7 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by IDeA States Pediatric Clinical Trials Network · Not applicable, Interventional, and Prevention
The INTACT trial is a multisite pilot feasibility study aimed at testing the effectiveness of the INTACT Intervention program in improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids. The trial will enroll 20 birthing parent/infant dyads across three sites and will evaluate feasibility endpoints rather than clinical outcomes. The study duration is 22 months, including study start-up, enrollment and intervention, and data analysis and manuscript preparation.
The INTACT trial is designed to address the need for interventions to improve neurodevelopmental outcomes in infants exposed to cannabinoids in utero. It is a multi-site pilot study conducted across three Institutional Development Award (IDeA) States Pediatric Clinical Trials Network (ISPCTN) sites. The trial aims to evaluate the feasibility of the INTACT Intervention program, which focuses on training birthing parents in contingent responding to promote early language, cognitive, and social development in their infants.
The study intervention consists of 12 monthly INTACT intervention coaching sessions, each comprising online module completion followed by personalized coaching sessions with interventionists certified to deliver the Play and Learn Strategies (PALS) methodology, which forms the basis for the INTACT intervention. The online modules focus on strengthening effective parenting practices, while the coaching sessions guide birthing parents in contingent responding techniques, such as reading infant signals and responding with warm and sensitive behaviors. There are three objectives for this study, examining 1) Participant Recruitment, 2) Participant Completion, and 3) Participant Adherence.
Objective 1 examines if birthing parents can be recruited and enrolled in the study. The endpoint of this objective is the percentage of potential participants approached for the study that are consented and determined to be eligible for study participation.
Objective 2 evaluates participant completion, as measured by the percent of birthing parent/infant dyads that complete the coaching session scheduled when the child is 12 months of age.
Objective 3 evaluates the number of individual INTACT intervention coaching sessions completed.
The study duration is planned for 22 months, including 1-4 months for study development and start-up, 3 months for enrollment, 12 months for the intervention, and 3 months for data organization, clean-up, and manuscript preparation.
The INTACT trial will not assess clinical outcomes but will inform the design of a future larger-scale clinical trial to evaluate the effectiveness of the INTACT Intervention program in improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids.
270 studies on the registry are indexed under Learning Disabilities; 62 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 181 interventional studies indexed under Learning Disabilities.
Browse Learning Disabilities studies →IDeA States Pediatric Clinical Trials Network is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Birthing Parent
Infant
Exclusion Criteria:
Birthing Parent
Infant
A novel program to train birthing parents in contingent responding with the goal of improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids. 1 personalized coaching session per month for 12 months.
Behavioral: Play and Learn Strategies (PALS) Program
Monthly modules and personalized coaching sessions designed to strengthen maternal responsiveness and sensitivity which, in turn, improves infant social-emotional behavior and development outcomes.
Also known as: ePALS
Percentage of approached participants that are eligible for study participation
Whether a potential participant approached for study participation will eventually be consented and determined to be eligible for study participation.
Time frame: 3 months
Percentage of participants that complete their final visit
Whether a birthing parent/infant dyad will complete the final coaching session when the child is 12 months of age.
Time frame: 12 months following enrollment
Percentage of participants that receive a sufficient number of coaching sessions
Whether a participant will complete the sufficient number of INTACT intervention coaching sessions, defined as completion of at least 8 out of 12 coaching sessions.
Time frame: 12 months following enrollment
Plan to share: Yes — We will conduct this trial in accordance with the following publication and data sharing policies and regulations: NIH Public Access Policy. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. ECHO ISPCTN Publications and Presentations Policy. It ensures accurate, responsible, and efficient communication of findings from ECHO ISPCTN clinical trials. NIH Data Sharing Policy and the policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Resulting Information Submission Rule. Other researchers may request data from this trial by contacting Song Ounpraseugh, PhD, at the ISPCTN Data Coordinating and Operations Center (DCOC).
Supporting information: Statistical analysis plan, Informed consent form
Time frame: Per data sharing polices of NIH and the ISPCTN
Access criteria: to be announced
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
IDeA States Pediatric Clinical Trials Network