Development and preliminary outcomes of module klefiden

Abstract

Children with cleft lip and/or palate (CL/P) face unique challenges in communication, social interactions, and school participation, which impact their overall quality of life. This study aimed to develop and evaluate Module Klefiden, a tool designed to enhance psychosocial and communication skills in primary school-age children with CL/P in Malaysia. The research followed a Design and Development Research (DDR) approach across three phases. Phase 1 involved a needs assessment through online semi-structured interviews with non-syndromic children with CL/P (n=14, ages 7-12), parents (n=16), and teachers (n=10) to identify communication facilitators, barriers, and strategies. Key facilitators included personal attributes like self-confidence and sociability. Parents emphasized fostering a positive mindset and religious beliefs to empower their children. Teachers highlighted interactive learning, such as group activities, and empathy towards children with CL/P. Barriers like cleft-related stigma, poor speech intelligibility, and psychosocial distress caused by peers were addressed through targeted activities in the module. Phase 2 focused on module development using the fuzzy Delphi method (n=10), nominal group technique (n=12), and content validity index (n=8). The expert panel rated the module highly, with face validity exceeding 85% and a content validity index of 0.86. Phase 3 involved feasibility (n=10) and quasi-experimental preliminary outcomes studies (n=17). The feasibility study showed most parents found Module Klefiden practical and acceptable, as indicated by the Treatment Evaluation Inventory-Short Form (mean = 37.08). In the preliminary outcomes study, the module was evaluated using the CLEFT-Q across four domains. The experimental group showed significant improvements in psychological function (Z = -2.668, p = 0.008, r = 0.889) and stress about speech (Z = -2.201, p = 0.028, r = 0.734), both indicating large effect sizes, while the control group showed no significant change. Both groups showed improvements in social participation (experimental: Z = -2.392, p = 0.017, r = 0.797; control: Z = -2.375, p = 0.018, r =0.840). Qualitative findings revealed increased confidence in children explaining their condition to peers and enhanced parental understanding of the diagnosis. The study concludes that Module Klefiden is a feasible intervention for improving psychosocial and communication skills in children with CL/P. Further research is recommended to confirm its effectiveness across larger populations.