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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04618822
Other study ID # 8018-00132B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date April 14, 2021

Study information

Verified date November 2022
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 149
Est. completion date April 14, 2021
Est. primary completion date February 19, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 7 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Teaching involving whole-body movements
The intervention consist of three 30 minutes sessions per week for eight weeks. Activities are conducted in small groups of six children and focus on the acquisition of letterforms, letter-sound correspondences and reading and spelling of short words. Activities involve whole-body movements and have been developed with the embodied learning theory in mind, linking movement closely to the learning content.
Teaching involving hand movements
The intervention consist of three 30 minutes sessions per week for eight weeks. Activities are conducted in small groups of six children and focus on the acquisition of letterforms, letter-sound correspondences and reading and spelling of short words. Activities involve movements using hands and arms and have been developed with the embodied learning theory in mind, linking movement closely to the learning content.
Teaching involving minimal motor movements (control)
The control condition consist of three 30 minutes sessions per week for eight weeks. Activities are conducted in groups of app. twelve children and focus on the acquisition of letterforms, letter-sound correspondences and reading and spelling of short words. Activities are completed seated on a chair using paper and pencil.

Locations

Country Name City State
Denmark University of Copenhagen Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in 1-back task accuracy and reaction time This 1-back task is constructed of representations of symbols (car, cloud, globe, note, headphones, airplane, plate, key, eye and bicycle); one symbol is presented at the time. Baseline, 8-weeks and 18-weeks
Other Change in digit span forwards and backwards accuracy (number of correctly remembered sequences and the number of digits in the longest correctly remembered sequence) The digit span task is a subtest of the Wechsler Intelligence Scale for Children - fourth edition (WISC-IV) (Wechsler, 2003) and is used to assess auditory working memory, attention, and concentration. The test consists of two subtests; digit span forward and digit span backwards. Baseline, 8-weeks and 18-weeks
Other Intrinsic motivation questionnaire Modified version of Intrinsic Motivation Inventory (IMI) (McAuley, Duncan, & Tammen, 1989). The original items of the IMI are translated into Danish using a translation-backtranslation process (Streiner & Norman, 2008). The inventory is reduced to six questions related to intrinsic motivation (question 1-3) and feeling of competences (question 4-6). Four times during study completion, immediately after one session in week two, four, six and eight
Other Change in Flamingo balance test, balance on one leg (sum of attempts with both legs; lower scores indicate better performance) The flamingo balance test is a standardized test that assesses the ability to balance successfully on one leg (Adam, C., Klissouras, V., Ravazzolo, M., Renson, R., & Tuxworth, 1988). Baseline, 8-weeks and 18-weeks
Other Change in 9-hole pegboard (speed) The 9-hole pegboard test is a standardized test which has previously been used in children to evaluate fine motor skills (Longcamp et al., 2005; Smith, Hong, & Presson, 2000). Baseline, 8-weeks and 18-weeks
Other Flamingo balance test, balance on one leg (sum of attempts with both legs; lower scores indicate better performance) The flamingo balance test is a standardized test that assesses the ability to balance successfully on one leg (Adam, C., Klissouras, V., Ravazzolo, M., Renson, R., & Tuxworth, 1988). Baseline
Other 9-hole pegboard (speed) The 9-hole pegboard test is a standardized test which has previously been used in children to evaluate fine motor skills (Longcamp et al., 2005; Smith, Hong, & Presson, 2000). Baseline
Other Letter-sound correspondence accuracy, Bogstaveprøve 2 ['Letter test 2'] This test has been widely used in the Danish school system. The test consists of two subtests assessing simple letter-sound knowledge and vowel identification, respectively. For the purpose of the present study, only the first subtest will be administered to assess standard letter-sound knowledge. Baseline
Other Word reading accuracy and speed, Ordlæseprøve 1 ['Word reading test 1'] This test is widely used in the Danish school system. The test consists of 78 items (preceded by two practice items) and evaluates word reading accuracy as well as efficiency. Baseline
Other Letter naming fluency accuracy This Danish version of the Letter Naming test is based on the same principles as DIBELS Letter Naming Fluency (Good & Kaminski, 2002). The test consists of a piece of paper (A4) with 12 rows of 10 letters (mixed upper- and lower case). Baseline
Primary Change from baseline in word reading speed and accuracy (reading of 18 trained words) at 8 weeks, computer-based test This word reading test consist of 18 presentations of targets words; one target word per presentation. Below the target word are placed four pictures of which one illustrates the target word. For the children to give a correct answer, they will have to touch the picture matching the target word on the touch screen. They are asked to touch the correct picture as fast as possible. The three remaining pictures represents words (distractors) that have either the initial (two pictures) or the final (one picture) sound in common with the target word. The presentations of target words and the order of the four pictures are randomized between subjects and time points. During the test, children are allowed to ask questions concerning the pictures (e.g. what is shown on this picture?) but not regarding the target word (e.g. what is the sound of this letter?). The results from the test constitute mean response time for correct answers and number of correct answers. Baseline and 8-weeks
Primary Change from baseline in trained letter-sound correspondences accuracy (15 trials) at 8 weeks, paper and pencil test The test consists of 15 trials. In each trial, a sound corresponding to a standard or a conditional pronunciation of a letter is said out loud by the assessor. Children are instructed to identify the correct letter matching the sound from a row of four letters. Before the test trials, children will be provided with one practice trial. The 15 sounds represent both standard and conditional pronunciations of the letters a, e, o, r, u and v. Results are numbers of correct letter-sound correspondences. Baseline and 8-weeks
Secondary Change from baseline in word reading accuracy (reading of 12 untrained words) at 8 weeks, computer-based test This test consists of 12 presentations of untrained words; one word per presentation. The 12 words consist of four 2-letter words, four 3-letter words and four 4-letter words. Baseline and 8-weeks
Secondary Change from baseline in letter naming fluency accuracy at 8 weeks This Danish version of the Letter Naming test is based on the same principles as DIBELS Letter Naming Fluency (Good & Kaminski, 2002). The test consists of a piece of paper (A4) with 12 rows of 10 letters (mixed upper- and lower case). Baseline and 8-weeks
Secondary Change from baseline in letter-sound correspondence accuracy, Bogstaveprøve 2 ['Letter test 2'] at 8 weeks This test has been widely used in the Danish school system. The test consists of two subtests assessing simple letter-sound knowledge and vowel identification, respectively. For the purpose of the present study, only the first subtest will be administered to assess standard letter-sound knowledge. Baseline and 8-weeks
Secondary Change from baseline in word reading accuracy and speed, Ordlæseprøve 1 ['Word reading test 1'] at 8 weeks This test is widely used in the Danish school system. The test consists of 78 items (preceded by two practice items) and evaluates word reading accuracy as well as efficiency. Baseline and 8-weeks
Secondary Change from baseline in word reading speed and accuracy (reading of 18 trained words) at 18 weeks, computer-based test This word reading test consist of 18 presentations of targets words; one target word per presentation. Below the target word are placed four pictures of which one illustrates the target word. For the children to give a correct answer, they will have to touch the picture matching the target word on the touch screen. They are asked to touch the correct picture as fast as possible. The three remaining pictures represents words (distractors) that have either the initial (two pictures) or the final (one picture) sound in common with the target word. The presentations of target words and the order of the four pictures are randomized between subjects and time points. During the test, children are allowed to ask questions concerning the pictures (e.g. what is shown on this picture?) but not regarding the target word (e.g. what is the sound of this letter?). The results from the test constitute mean response time for correct answers and number of correct answers. Baseline and 18-weeks
Secondary Change from baseline in trained letter-sound correspondences accuracy (15 trials) at 18 weeks, paper and pencil test The test consists of 15 trials. In each trial, a sound corresponding to a standard or a conditional pronunciation of a letter is said out loud by the assessor. Children are instructed to identify the correct letter matching the sound from a row of four letters. Before the test trials, children will be provided with one practice trial. The 15 sounds represent both standard and conditional pronunciations of the letters a, e, o, r, u and v. Results are numbers of correct letter-sound correspondences. Baseline and 18-weeks
Secondary Change in word reading speed and accuracy (reading of 18 trained words) between 8 weeks and 18 weeks, computer-based test This word reading test consist of 18 presentations of targets words; one target word per presentation. Below the target word are placed four pictures of which one illustrates the target word. For the children to give a correct answer, they will have to touch the picture matching the target word on the touch screen. They are asked to touch the correct picture as fast as possible. The three remaining pictures represents words (distractors) that have either the initial (two pictures) or the final (one picture) sound in common with the target word. The presentations of target words and the order of the four pictures are randomized between subjects and time points. During the test, children are allowed to ask questions concerning the pictures (e.g. what is shown on this picture?) but not regarding the target word (e.g. what is the sound of this letter?). The results from the test constitute mean response time for correct answers and number of correct answers. 8-weeks and 18-weeks
Secondary Change in trained letter-sound correspondences accuracy (15 trials) between 8 weeks and 18 weeks, paper and pencil test The test consists of 15 trials. In each trial, a sound corresponding to a standard or a conditional pronunciation of a letter is said out loud by the assessor. Children are instructed to identify the correct letter matching the sound from a row of four letters. Before the test trials, children will be provided with one practice trial. The 15 sounds represent both standard and conditional pronunciations of the letters a, e, o, r, u and v. Results are numbers of correct letter-sound correspondences. 8-weeks and 18-weeks
Secondary Change in word reading accuracy (reading of 12 untrained words) between 8 weeks and 18 weeks, computer-based test This test consists of 12 presentations of untrained words; one word per presentation. The 12 words consist of four 2-letter words, four 3-letter words and four 4-letter words. 8-weeks and 18-weeks
Secondary Change in letter naming fluency accuracy between 8 weeks and 18 weeks This Danish version of the Letter Naming test is based on the same principles as DIBELS Letter Naming Fluency (Good & Kaminski, 2002). The test consists of a piece of paper (A4) with 12 rows of 10 letters (mixed upper- and lower case). 8-weeks and 18-weeks
Secondary Change in letter-sound correspondence accuracy, Bogstaveprøve 2 ['Letter test 2'] between 8 weeks and 18 weeks This test has been widely used in the Danish school system. The test consists of two subtests assessing simple letter-sound knowledge and vowel identification, respectively. For the purpose of the present study, only the first subtest will be administered to assess standard letter-sound knowledge. 8-weeks and 18-weeks
Secondary Change in word reading accuracy and speed, Ordlæseprøve 1 ['Word reading test 1'] between 8 weeks and 18 weeks This test is widely used in the Danish school system. The test consists of 78 items (preceded by two practice items) and evaluates word reading accuracy as well as efficiency. 8-weeks and 18-weeks
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