Addressing the Unmet Needs of Parent Mental Health: The FACT proof of concept trial for parents of children born with cleft lip and palate

Background: Congenital anomalies are a leading cause of infant morbidity and mortality. Cleft lip and/or palate (CL/P) is the most common craniofacial anomaly, affecting approximately 6,000-8,000 infants annually in the United States. Parents of children with CL/P report elevated levels of stress, anxiety, and depression, particularly during the first year of life when feeding challenges, medical procedures, and social stressors are most intense. Despite well-documented impacts on both parent and child outcomes, psychological support is not routinely integrated into cleft care. Focused Acceptance and Commitment Therapy (FACT) is a brief, scalable intervention designed to enhance psychological flexibility and reduce distress. However, FACT has not been evaluated in parents of infants with CL/P. Methods: This single-site pilot study will evaluate the feasibility and proof of concept of FACT among 30 parents or caregivers of infants (0-12 months) receiving outpatient CL/P care. Participants will attend two 90-minute virtual FACT group sessions delivered in cohorts of 3-5 families. Primary outcomes include parental stress (Perceived Stress Scale-10) and anxiety (GAD-7), assessed at baseline and two weeks post-intervention. Secondary outcomes include depressive symptoms (PHQ-9), traumatic stress (IES-R), and psychological flexibility (AAQ-II). Feasibility metrics will include recruitment, retention, assessment completion, and intervention completion rates, supplemented by qualitative feedback. Proof-of-concept analyses will use the Reliable Change Index (RCI) to assess clinically meaningful individual-level changes. We hypothesize that FACT will be feasible to deliver and associated with meaningful reductions in parental stress and anxiety. Mixed-methods findings will inform future refinement and implementation strategies. Discussion: This pilot study represents the first evaluation of FACT specifically for parents of infants with CL/P and the first to examine its effects on stress-related outcomes within cleft care during the first year of life. By embedding a brief, scalable psychological intervention within multidisciplinary cleft services, this study addresses a persistent gap between documented psychosocial need and routine care delivery. If feasible and effective, FACT could offer an accessible, early intervention model to strengthen parental psychological flexibility and mental health during a critical developmental window, with potential downstream benefits for feeding, parent-infant interaction, and child developmental outcomes.