Active — Not RecruitingNot Applicable

Effectiveness of an Early Reading Intervention for Young Children With Intellectual Disabilities Who Need or Use Augmentative and Alternative Communication

Norway120 participantsStarted 2025-08-15

Plain-language summary

The goal of this 2x2 factorial randomized controlled trial is to evaluate the effectiveness of two literacy interventions delivered at different time points, in kindergarten and in first grade, on the development of literacy skills in children with intellectual disabilities who require augmentative and alternative communication. The main questions it aims to answer are: * Does early intervention in kindergarten lead to greater improvements in phonological and phonemic awareness, vocabulary, and articulation compared to training as usual? * Does a follow-up intervention in first grade enhance decoding skills and sight word recognition beyond the gains achieved through the kindergarten intervention alone? * Does phonological awareness at the end of kindergarten mediate the relationship between early intervention and later outcomes in vocabulary, articulation, and decoding? * Do children who receive both interventions perform better than those who receive only one or none (training as usual), suggesting a cumulative or higher-dose effect? Researchers will compare four arms formed through a 2x2 factorial design after randomization to see if whether timing, combination, and sequencing of interventions produce differential effects on literacy outcomes. Participants will: * In kindergarten receive either an early literacy intervention or training as usual. * In first grade receive either a follow-up literacy intervention or training as usual, depending on group allocation. * Be assessed at key time points in both years, measuring phonological awareness, phonemic awareness, vocabulary, and articulation in kindergarten, and expanding to include decoding and sight word recognition in first grade.

Who can participate

Age range

4 Years – 8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * children diagnosed with intellectual disability, confirmed by multidisciplinary assessments carried out by the Child rehabilitations service or currently undergoing such an evaluation * ages 4-8 (the last year in kindergarten) * lack of functional speech and must use augmentative and alternative communication as the primary form of communication * have a (designated) special education kindergarten teacher Exclusion Criteria: * having a severe visual or hearing impairment * children who can decode syllables or words * children with severe physical disabilities prevent the children from being able to answer with their fingers, unless they can respond with eye pointing or signs

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phonological Awareness and Letter-Sound Correspondence Assessed in Kindergarten

Timeframe: 5 weeks

Phonological Awareness, Letter-Sound Correspondence and Decoding Assessed in First Grade

Timeframe: 5 weeks

Trial details

NCT IDNCT07116200

SponsorOstfold University College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12

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