Intervention Effectiveness Study of BEtter AT LEarning (BEATLE)- Digital Neuropsychological Rehabilitation Program

NCT ID: NCT06713863

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2028-04-30

Brief 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.

Detailed Description

BEATLE (BEtter AT LEarning) is a neuropsychological digital rehabilitative program (Digital Care Pathway, DCP) developed at the Department of Phoniatrics, University Hospital of Helsinki and Uusimaa region (HUS). The purpose of this DCP is to provide knowledge on meta-skills and tools for learning to 12-16-year-olds who experience learning difficulties due to developmental language disorder, dyslexia, or other developmental issues.

The aforementioned developmental disorders can have long-lasting impacts on individuals' lives. For instance, children with DLD have been reported to have a lower quality of life than typically developing children, according to parent evaluations. Self-evaluation is a crucial aspect of individual performance and well-being. Albert Bandura's social cognitive theory posits that individuals are proactive and reflective beings who simultaneously shape and are shaped by their environment (Reciprocal Determinism). According to Bandura, individuals constantly evaluate and form beliefs about their capabilities to perform in given situations (Self-efficacy). The theory of self-efficacy is often employed in educational sciences, where students with higher self-efficacy beliefs have been found to exert more effort in schoolwork, perform better academically, and have a more positive attitude toward school. Primary school students with specific learning difficulties have been reported to have lower self-efficacy beliefs than their peers.

Another perspective on self-evaluation and perception of difficulties can be explored through the concept of self-compassion. Neff defines self-compassion as a multifaceted construct that encompasses how individuals emotionally respond to suffering, cognitively understand their predicament, and pay attention to their suffering. A longitudinal study found that ninth-grade students with low self-esteem but high self-compassion exhibited better psychological health one year later compared to those with low self-compassion. Self-compassion has demonstrated its utility as a framework for interventions.

The aim of BEATLE is to provide understanding, inspiration, and tools for better learning in adolescents. This study aims to (1) analyze the effectiveness and feasibility of the BEATLE online rehabilitative course in three clinical groups (DLD, Dyslexia, and Mixed Specific Developmental Disorder) and (2) explore the potential differences in effectiveness among these diagnostic groups. For example, participants with dyslexia may report better and more lasting outcomes than participants with DLD or Mixed Specific Developmental Disorder, considering that the DCP includes several strategies for using digital tools such as dictation and text-to-speech, which can aid with primary difficulties related to reading and writing.

The study will employ a randomized controlled trial with a waitlist design. The objective is to assess potential changes in perceived self-efficacy, self-compassion, executive functioning, and attitudes toward learning as reported by participants, guardians (parents), and teachers. Additionally, this study aims to examine the correlation between the usage of the DCP and its effectiveness.

Participants will be recruited from 12-16-year-old patients referred to HUS Phoniatrics or HUS Pediatric Neurology. The target sample size is 52 participants per group (26 in the intervention group and 26 in the waitlist group), totaling 156 complete participants. Accounting for a conservative dropout rate of 50%, up to 312 participants may be required for recruitment. Another digital health program (DHP) on acquired brain injury patients in adults has reported a dropout rate of approximately 20%.

Recruitment will be conducted by neuropsychologists at respective clinics. After expressing willingness to participate, participants and their guardians will sign consent forms. Participants will then receive an envelope containing study materials and a consent form for their teacher to sign. Participation in the study does not supersede any other treatment.

Signed consent forms will be submitted to the research team, after which participants will be randomized into either the intervention group or the waitlist group. Randomization will be conducted in RedCap to minimize the risk of bias. Participants in the intervention group will receive an invitation to the DCP a few days after signing the agreement and completing the pre-intervention questionnaires. Participants in the waitlist group will first complete baseline questionnaires and will then wait 10 weeks before entering the cross-over phase and receiving access to the DCP.

Conditions

Dyslexia, Developmental; Developmental Language Disorder; Specific Learning Disorder; Borderline Intellectual Functioning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention first

Participant directly enrolled to the intervention

Group Type: EXPERIMENTAL

BEtter AT LEarning (BEATLE)- Digital Care Pathway

Intervention Type: OTHER

BEATLE is a digital care pathway consisting of ten episodes resembling an online course. The episodes are designed to be multimodal and immersive, incorporating text, recorded voice, pictures, cartoons, videos and peer support through given examples and case stories. Participants are encouraged to access BEATLE through a web browser on a computer, although it is also accessible through a mobile application. Participants have control over the pace of completing the BEATLE, but there must be a minimum five-day break between episodes. In other words, it is possible to complete the BEATLE in seven weeks.

All participants are referred to the BEATLE by a neuropsychologist and are strongly authenticated in the healthvillage.fi online platform. Each participant is assigned a designated neuropsychologist who tracks their progress in the BEATLE and to whom messages and questions can be sent by the participant.

Waitlist first

Participant spends amount of time similar to completing the intervention in a waitlist after which gets enrolled into the intervention after post-waitlist measures have been completed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

BEtter AT LEarning (BEATLE)- Digital Care Pathway

BEATLE is a digital care pathway consisting of ten episodes resembling an online course. The episodes are designed to be multimodal and immersive, incorporating text, recorded voice, pictures, cartoons, videos and peer support through given examples and case stories. Participants are encouraged to access BEATLE through a web browser on a computer, although it is also accessible through a mobile application. Participants have control over the pace of completing the BEATLE, but there must be a minimum five-day break between episodes. In other words, it is possible to complete the BEATLE in seven weeks.

All participants are referred to the BEATLE by a neuropsychologist and are strongly authenticated in the healthvillage.fi online platform. Each participant is assigned a designated neuropsychologist who tracks their progress in the BEATLE and to whom messages and questions can be sent by the participant.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Suspicion of mild intellectual disability Both verbal and non-verbal reasoning skills more than two standard deviations lower than average (VCI & PRI < 70) Weak (-2 Standard Deviations) performance on both subtests representing fluid intelligence (Wechsler's Intelligence Scale for Children IV (WISC-IV): Matrix reasoning and Picture concepts)

Diagnosis of Autism Spectrum Disorder

Untreated Attention-Deficit Hyperactivity Disorder

Unable to adequately use a a computer and/or a smartphone

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sari-Anne Levänen

PhD, Neuropsychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pediatric Neurology, Helsinki University Hospital

Helsinki, , Finland

Site Status: RECRUITING

Phoniatrics, Helsinki University Hospital

Helsinki, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Markus S. Hannukkala, PhD Student, M.A.

Role: CONTACT

samuel.hannukkala@hus.fi

+358407057351

Facility Contacts

Markus S. Hannukkala, PhD Student, M.A.

Role: primary

samuel.hannukkala@hus.fi

+358407057351

Sari Levänen, PhD

Role: primary

Sari-anne.levanen@hus.fi

+358504287228

Other Identifiers

HUS/6774/2023

Identifier Type: -

Identifier Source: org_study_id