Pilot Protocol for the Parent and Infant Inter(X)action Intervention (PIXI) Feasibility Study

This paper provides the detailed protocol for a pilot study testing the feasibility, acceptability, and initial efficacy of a targeted two-phase, remotely delivered early intervention program for infants with neurogenetic conditions (NGC) and their caregivers. The Parent and Infant Inter(X)action Intervention (PIXI) is designed to support parents and infants with an NGC diagnosed in the first year of life. PIXI is implemented in two phases, with the first phase focusing on psychoeducation, parent support, and how to establish routines for supporting infant development. Phase II helps parents learn targeted skills to support their infant’s development as symptoms may begin to emerge. The proposed case series will establish the feasibility of a year-long virtually implemented intervention program to support new parents of an infant diagnosed with an NGC. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial Clinicaltrials.gov [NCT03836300][1] ### Funding Statement AW John Merck Fund The funders had and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Not Applicable The details of the IRB/oversight body that provided approval or exemption for the research described are given below: UNC Chapel Hill IRB Number 18-2079 I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Not Applicable I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Not Applicable I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Not Applicable No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03836300&atom=%2Fmedrxiv%2Fearly%2F2022%2F06%2F07%2F2022.06.07.22276083.atom