The study design of ComAlong Toddler: a randomised controlled trial of an early communication intervention.

Aims: This study design article aims to describe a research study focused on evaluating the use of the Infant-Toddler Checklist to identify children at 18 months with early communication difficulties, and to study the ComAlong Toddler intervention for parents to support their child's communication development. Background: Communication disorders are a common public health problem affecting up to 20% of children. Evidence points to the importance of early detection and intervention to improve young children's communicative abilities and decrease developmental delay. Early identification of communication difficulties is possible with instruments such as Infant-Toddler Checklist. The ComAlong Toddler intervention is tailored to the needs of parents of young children with communication delay before definitive diagnosis. The parents are provided with guidance in communication enhancing strategies during home visit and five group sessions. Methods: The study uses a prospective cohort design. Children were consecutively recruited during 2015-2017, and data will be collected 2015-2023. The screening was performed at the child health centre through use of the Infant-Toddler Checklist. An assessment and first consultation were then performed by a speech and language therapist for children with suspected communication delay according to the screen as well as for children referred for other reasons before the age of 2.5 years. Children with confirmed communication delay were randomised between two interventions: the ComAlong Toddler parental course or a telephone follow-up. Outcome measures include child communication and language skills and use of augmentative and alternative communication. To gain insight into the participants' perspectives, surveys have been collected from parents. Conclusion: The study will provide information regarding identification and intervention for 18-month old children with communication delay. Trial registration: ISRCTN13330627.