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

NCT06713863 | Recruiting DMC

• 1 other identifier: HUS/6774/2023
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

eHealth; Adolescence; Intervention; Effectiveness; RCT

Outcome Measures

Primary Outcomes (2)

• Self-Efficacy Questionnaire for Children and Adolescents (SEQ-C)

  A brief questionnaire assessing perceived academic, emotional and social self-efficacy. Scale scores will be calulated for academic (Min 8 - Max 40), emotional ( Min 7 - 35) and social self-efficacy (Min 8 - Max 40). A total self-efficacy score will also be calculated as a sum of abovementioned three scale scores (Min 23 - Max 115).

  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.

• Sussex-Oxford Compassion Scale - Self (SOCS-S)

  A brief questionnaire intended to measure perceived self-compassion. The measure consists of 20 items that are answered on 5-step likert scale. Five scale sum scores will be calculated from the measure: Recognition of suffering (Min 4 - Max 20), Understanding the universality of suffering (Min 4 - Max 20), Feeling sympathy for those who are suffering (Min 4 - Max 20), Tolerating the distress associated with the witnessing of suffering (Min 4 - Max 20) and Motivation to act to alleviate the suffering (Min 4 - Max 20). A total self-compassion score will also be calculated that is the sum of above mentioned five scale scores (Min 20 - Max 100).

  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 (2)

• 5-15

  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.

• The Strengths and Difficulties Questionnaire (SDQ)

  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.

Study Arms (2)

Intervention first

EXPERIMENTAL

Participant directly enrolled to the intervention

Other: BEtter AT LEarning (BEATLE)- Digital Care Pathway

Waitlist first

NO INTERVENTION

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.

Interventions

BEtter AT LEarning (BEATLE)- Digital Care Pathway 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.

Intervention first

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (2)

Pediatric Neurology, Helsinki University Hospital

Helsinki, Finland

RECRUITING

Phoniatrics, Helsinki University Hospital

Helsinki, Finland

RECRUITING

MeSH Terms

Conditions

Dyslexia; Language Development Disorders; Specific Learning Disorder

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

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

CONTACT

+358407057351; samuel.hannukkala@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Neuropsychologist

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 3, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 8, 2025

Record last verified: 2025-03

Locations

FI (2)