Clinical trial NCT06713863: Intervention Effectiveness Study of BEtter AT LEarning (BEATLE)- Digital Neuropsychological Rehabilitation Program
Official title: Intervention Effectiveness Study of BEtter AT LEarning (BEATLE)- Digital Neuropsychological Rehabilitation Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dyslexia, Developmental
Developmental Language Disorder
Specific Learning Disorder
Borderline Intellectual Functioning
Keywords: eHealth
Adolescence
Intervention
Effectiveness
RCT
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 312
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 criteria are formed as follows:

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

Primary outcomes:
measure: 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.
measure: 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.
Secondary outcomes:
measure: 5-15
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.
measure: The Strengths and Difficulties Questionnaire (SDQ)
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.
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Pediatric Neurology, Helsinki University Hospital
city: Helsinki
country: Finland
facility: Phoniatrics, Helsinki University Hospital
Study officials:
References: