Intervention Effectiveness Study of BEtter AT LEarning (BEATLE)- Digital Neuropsychological Rehab… (NCT06713863) | Clinical Trial Compass
RecruitingNot Applicable
Intervention Effectiveness Study of BEtter AT LEarning (BEATLE)- Digital Neuropsychological Rehabilitation Program
Finland312 participantsStarted 2025-05-01
Plain-language summary
The purpose of this study is to evaluate the effectiveness of BEATLE with clinical samples of patients diagnosed with Developmental Language Disorder (DLD), Dyslexia, and Mixed Specific Developmental Disorder. A randomized controlled trial with a waitlist design will be employed. The objective is to assess potential changes in perceived self-efficacy, self-compassion, executive functioning, and attitudes toward learning as reported by the participants, their guardians (parents), and teachers. Additionally, this study aims to examine the correlation between the usage of the Digital Care Pathway (DCP) and its effectiveness.
Who can participate
Age range
12 Years – 16 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.
For inclusion, the International Classification of Diseases 10th edition (ICD-10; WHO, 2018) diagnostic criteria accompanied with Finnish Current Care Guidelines will be used as follows:
Developmental Language Disorder Verbal reasoning skills (Verbal Reasoning Index = VCI) 1.5 standard deviations lower than average (\< 78 Index points) Intact non-verbal reasoning skills (Perceptual Reasoning Index = PRI) \> 84 index points) Normal or fixed to normal hearing and vision Adequate skills in Finnish: Finnish either as a native language, major household language or adequate reported performance in Finnish school system.
Dyslexia Measured reading accuracy and comprehension two standard deviations (-2 standard deviations) lower than anticipated when the chronological age and IQ have been taken into account Normal of fixed to normal hearing and vision Adequate skills in Finnish: Finnish either as a native language, major household language or adequate reported performance in Finnish school system.
Mixed Developmental Disorder Wide developmental and learning difficulties (69 \< PRI \< 84, 69 \< VCI \< 84) Normal or fixed to normal hearing and vision Adequate skills in Finnish: Finnish either as a native language, major household language or adequate reported performance in Finnish school system.
Exclusion Criteria:
All exclusion criteria will be addressed individually. If a respondent fulfills one or more of the exclusion criteria, the respondent will be dropped out. Exclusion cri…
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
1
Self-Efficacy Questionnaire for Children and Adolescents (SEQ-C)
Timeframe: Filled three to four times in different phases of the study. Both arms fill the measure before the intervention, after intervention and three months after the intervention. Waitlist- arm also fills the measure on the start of the waitlist period.
2
Sussex-Oxford Compassion Scale - Self (SOCS-S)
Timeframe: Filled three to four times in different phases of the study. Both arms fill the measure before the intervention, after intervention and three months after the intervention. Waitlist- arm also fills the measure on the start of the waitlist period.