Clinical trial NCT04618822: Play-based Motor-Cognitive Training for Improved Reading
Official title: Motor-enriched Learning for Improving Pre-reading and Word Recognition Skills in Preschool Children Aged 5-6 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reading
Keywords: motor-enriched learning
embodied learning
physically active lessons
pre-reading skills
word recognition
preschool children
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 149
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A three-armed randomized controlled trial
Primary purpose: OTHER

Brief summary: The PLAYMORE study aims to investigate the effects of two interventions focusing on a close and meaningful coupling between bodily movement and academic content on early pre-reading and word recognition skills in children. Further, the study aims to compare two interventions involving either hand movements (i.e. using arms and hands) or whole-body movements (i.e. using the whole body). Potential mediating factors underlying the potential effect of bodily movement on early pre-reading and word recognition skills will be explored. The PLAYMORE study will be conducted as a three-armed randomized controlled trial including children aged five to six years recruited from four schools in the Copenhagen area, Denmark. Stratified by class, children will be randomly allocated to one of three 8-week intervention/control periods: 1) teaching involving whole-body movements, 2) teaching involving hand movements (i.e. arms and hands) or 3) teaching involving minimal motor movements (i.e. seated on a chair using paper and pencil). Outcome measurements, including pre-reading and word recognition skills, will be collected before and after the intervention period to assess the intervention effects. This study protocol follows the SPIRIT guidelines.


Eligibility criteria: Inclusion Criteria:

* Children five to six years old who have just started school

Exclusion Criteria:

* Children who do not speak any Danish
* Children with cognitive or physical disabilities hindering participation in the project activities

Primary outcomes:
measure: Change from baseline in word reading speed and accuracy (reading of 18 trained words) at 8 weeks, computer-based test
timeFrame: Baseline and 8-weeks
measure: Change from baseline in trained letter-sound correspondences accuracy (15 trials) at 8 weeks, paper and pencil test
timeFrame: Baseline and 8-weeks
Secondary outcomes:
measure: Change from baseline in word reading accuracy (reading of 12 untrained words) at 8 weeks, computer-based test
timeFrame: Baseline and 8-weeks
measure: Change from baseline in letter naming fluency accuracy at 8 weeks
timeFrame: Baseline and 8-weeks
measure: Change from baseline in letter-sound correspondence accuracy, Bogstaveprøve 2 ['Letter test 2'] at 8 weeks
timeFrame: Baseline and 8-weeks
measure: Change from baseline in word reading accuracy and speed, Ordlæseprøve 1 ['Word reading test 1'] at 8 weeks
timeFrame: Baseline and 8-weeks
measure: Change from baseline in word reading speed and accuracy (reading of 18 trained words) at 18 weeks, computer-based test
timeFrame: Baseline and 18-weeks
measure: Change from baseline in trained letter-sound correspondences accuracy (15 trials) at 18 weeks, paper and pencil test
timeFrame: Baseline and 18-weeks
measure: Change in word reading speed and accuracy (reading of 18 trained words) between 8 weeks and 18 weeks, computer-based test
timeFrame: 8-weeks and 18-weeks
measure: Change in trained letter-sound correspondences accuracy (15 trials) between 8 weeks and 18 weeks, paper and pencil test
timeFrame: 8-weeks and 18-weeks
measure: Change in word reading accuracy (reading of 12 untrained words) between 8 weeks and 18 weeks, computer-based test
timeFrame: 8-weeks and 18-weeks
measure: Change in letter naming fluency accuracy between 8 weeks and 18 weeks
timeFrame: 8-weeks and 18-weeks
measure: Change in letter-sound correspondence accuracy, Bogstaveprøve 2 ['Letter test 2'] between 8 weeks and 18 weeks
timeFrame: 8-weeks and 18-weeks
measure: Change in word reading accuracy and speed, Ordlæseprøve 1 ['Word reading test 1'] between 8 weeks and 18 weeks
timeFrame: 8-weeks and 18-weeks
Other outcomes:
measure: Change in 1-back task accuracy and reaction time
timeFrame: Baseline, 8-weeks and 18-weeks
measure: Change in digit span forwards and backwards accuracy (number of correctly remembered sequences and the number of digits in the longest correctly remembered sequence)
timeFrame: Baseline, 8-weeks and 18-weeks
measure: Intrinsic motivation questionnaire
timeFrame: Four times during study completion, immediately after one session in week two, four, six and eight
measure: Change in Flamingo balance test, balance on one leg (sum of attempts with both legs; lower scores indicate better performance)
timeFrame: Baseline, 8-weeks and 18-weeks
measure: Change in 9-hole pegboard (speed)
timeFrame: Baseline, 8-weeks and 18-weeks
measure: Flamingo balance test, balance on one leg (sum of attempts with both legs; lower scores indicate better performance)
timeFrame: Baseline
measure: 9-hole pegboard (speed)
timeFrame: Baseline
measure: Letter-sound correspondence accuracy, Bogstaveprøve 2 ['Letter test 2']
timeFrame: Baseline
measure: Word reading accuracy and speed, Ordlæseprøve 1 ['Word reading test 1']
timeFrame: Baseline
measure: Letter naming fluency accuracy
timeFrame: Baseline
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
Study officials:
References:
citation: Gejl AK, Malling ASB, Damsgaard L, Veber-Nielsen AM, Wienecke J. Motor-enriched learning for improving pre-reading and word recognition skills in preschool children aged 5-6 years - study protocol for the PLAYMORE randomized controlled trial. BMC Pediatr. 2021 Jan 4;21(1):2. doi: 10.1186/s12887-020-02430-0.