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Effects of Remote Microphone Hearing Aids on Children With Auditory Processing Disorder

Effects of Remote Microphone Hearing Aids on Classroom Listening, Spatial Listening, and Attention in School-Aged Children With Auditory Processing Disorder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02353091
Enrollment
26
Registered
2015-02-02
Start date
2016-05-31
Completion date
2017-09-30
Last updated
2020-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Auditory Processing Disorder

Brief summary

Auditory Processing Disorder (APD) is a disorder where the functions of the ear are normal, but the person has difficulty identifying or discriminating sounds and experiences listening difficulties in noise. Remote Microphone Hearing Aids (RMHAs) are wireless listening devices that pick up the speaker's voice and transmit it to a receiver in the listener's ear. In this way, the negative effects of ambient noise, distance from speaker and reverberation are reduced. The research questions are whether RMHAs improve classroom listening, listening in noise performance, listening in spatialised noise and auditory attention, in children with APD. We hypothesize that RMHA use will lead to improved classroom listening and improved speech-in-noise skills after 6 months of RMHA use. Additionally, we hypothesise that listening in spatialised noise and attention skills will remain unchanged following the intervention period. Twenty-six (26) children aged 7-12 with a diagnosis of an APD from the Great Ormond Street Hospital Audiology clinic were included in the study.

Detailed description

Auditory Processing Disorder (APD) is a disorder where the functions of the ear (outer, middle, inner) are normal but the person has difficulty identifying or discriminating sounds (1). For children with APD it is particularly difficult to hear when the listening conditions are not ideal. For example, when there is background noise it becomes really challenging to focus on the speaker. Two other factors that influence their hearing ability are reverberation and the distance from the speaker (2). Some symptoms reported for APD are listening difficulties in background noise, attention and memory problems, and distractibility (3,4). Children with APD have worse skills in speech perception in noise compared to typically developing children (5,6) and have also have poorer sustained auditory attention compared to children suspected of APD (7). Remote Microphone Hearing Aids (RMHAs) are a management approach recommended for children with APD. These are wireless listening devices that pick up the speaker's voice and transmit it to a receiver in the listener's ear. The use of this system helps improve the signal-to-noise ratio for children and bypasses the negative effects of background noise and reverberation in the classroom (2,8,9). There have not been many studies, though. That looked into the effects of RMHA on children with APD. Previous research suggests that children with APD after a prolonged use of RMHAs benefit from improved speech perception which is possibly linked to an enhanced auditory system (9). Adding to that, children with APD have shown improved speech in noise perception when using the RMHA, hence emphasizing the advantages of the device in discriminating speech in background noise (9,10). Sustained attention and the ability of children with APD to listen in spatialised noise after RMHA use has been examined by one study (10). It did not show improvement (unaided) in any of the two tests. However, this was a non-randomised trial that did not use a control group. As the central point of this study will be the use of the RMHA by children with APD for 6 months, it is expected that the findings could add valuable information on the subject. Aim and hypotheses The aim of the study is to examine the effect of a 6-month RMHA use on self-reported listening in the classroom, speech perception in noise, speech perception in spatialised noise and on attention skills. Hypotheses: i. Children with APD who use RMHAs will show greater improvements in classroom listening, listening in noise and sustained auditory attention (unaided) after 6 months of RMHA use in comparison to the APD control group. ii. Children with APD who use the RMHA will not show greater improvements in listening in spatialised speech noise and divided and visual attention measures after 6 months of RMHA use in comparison to the APD control group. Research Design and Methodology Participants and Recruitment We recruited 26 children aged 7-12 years. All children have been diagnosed and referred from the Auditory Processing Disorders Clinic at Great Ormond Street Hospital. The total sample size was decided using this power sample: N = 24 (total sample size) calculated using the F test for repeated measures between-within interaction ANOVA based on an estimated 0.5 effect size f(U), 80% power, at 5% significance, using 2 groups and 3 measurement points. Accounting for a 10% loss due to follow-up, the final study sample size comprised 26 children. Inclusion criteria: 1. Diagnosis of APD based on clinical tests administered by qualified audiologists as per the clinic's diagnosis protocol. 2. No neurological or pervasive disorder or developmental delay (e.g. Attention Deficit Hyperactivity Disorder, epilepsy, Autism Spectrum Disorder, Developmental Language Disorder, Down Syndrome). 3. Non-verbal cognitive ability score of 85 or greater. 4. Ages between 7-12 years. 5. Native English speakers. 6. No prior use of RMHAs. Subjects were semi-randomly assigned to each of two intervention arms. The two groups were stratified for age and balanced for gender. Children were given RMHAs to use at school and were compared to the control that did not use any intervention for the study period. Children were enrolled in the study for 6 months. All groups were tested before the start of the RMHA intervention, after 3 months, and at the end of the study (after 6 months). Explanation of each test: 1. A hearing test (Pure Tone Audiometry approx. 10mins). To determine their hearing is normal. 2. Non-verbal IQ test (Weschler test of non-verbal intelligence). To be performed by the PhD Student. (approx. 15mins). To assess determine whether their intelligence level is above normal. 3. Listening in spatialised noise test (LiSN-S, approx. 15mins). To be administered through the use of headphones by the PhD student. To determine their listening in spatialised speech noise abilities. 4. The Test of Everyday Attention for Children (TEACh). To be conducted as play type activities by the PhD student after receiving sufficient training by the clinical psychologist. (approx. 45mins possibly cut down to 30mins). To assess their attention. 5. Two questionnaires to be filled by the children's parents. 1. The Children's Communication Checklist-2 (CCC-2). A 70-item questionnaire which screens for communication problems (including language disorders and autism). 2. The Children's Auditory Performance Scale (CHAPS). It assesses aspects of children's listening. 6. One questionnaire to be completed by the children (Listening Inventory For Education-Revised \[LIFE-R\] for assessing their listening difficulty. Data analysis: Data were analysed in SPSS statistics software, using mixed ANOVA. Group was the between-subjects factor and time was the within-subjects factor. Ethical issues School and teacher involvement: The teachers of the children who received the RMHA were provided with an information sheet and consent form and were required to wear the microphone (which picks up the teacher's voice and transmits it wirelessly to the ear receivers in the child's ear) for the duration of lecture-based subjects. Remote microphone hearing aids are generally beingg provided (funded by the school budget) to some children after clinical recommendations and this is not an unusual situation within the school environment. We liaised with the teacher of the school to ensure that the school was aware that the student has been issued with the RMHA. A general guide for the system was made available in addition to information conveyed by the PhD student. Informed consent: The child's parents were given detailed written information and consent forms to sign. They were given up to a week to study and decide whether they wished for their child to participate in the study. They were only allowed to take part once they have understood the purpose and procedures of the study and they signed the consent forms. In addition, children were also given information sheets adjusted to their age. Written assent from children in the presence of their parents or carers was sought. Rights to withdraw from the study: This was outlined on both the information sheet and consent form and explained verbally during test visits. This information stated that participants were allowed to withdraw from the study at any point should they wished to. Withdrawal from the study did not involve any penalty or loss of benefit to them - this information was clearly underlined at the information sheet and verbally communicated. Data protection: Parents of the participants and the participants were informed that their information was anonymised and kept confidential. Data was anonymised prior to analysis by the use of participant codes. Storage of the data was in accordance with the data protection act 1998. Other issues: None of these tests were invasive or unpleasant, and they were conducted in comfortable sound levels (slightly higher than the usual conversational level). References 1. Dawes P, Bishop DVM. Auditory Processing Disorder in Relation to Developmental Disorders of Language, Communication and Attention: A Review and Critique. Int J Lang Commun Disord \[Internet\]. 2009 \[cited 2014 Apr 1\];44(4):440-65. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19925352 2. Keith WJ, Purdy SC. Assistive and Therapeutic Effects of Amplification for Auditory Processing Disorder. Semin Hear \[Internet\]. 2014;35(1):27-38. Available from: https://www.thieme-connect.com/products/ejournals/html/10.1055/s-0033-1363522 3. American Speech-Language-Hearing Association. (Central) Auditory Processing Disorders. Technical Report \[Internet\]. American Speech-Language-Hearing Association. 2005 \[cited 2019 Aug 6\]. Available from: http://www.asha.org/policy/TR2005-00043/ 4. American Academy of Audiology. American Academy of Audiology Clinical Practice Guidelines. Diagnosis, Treatment and Management of Children and Adults with Central Auditory Processing Disorder \[Internet\]. American Academy of Audiology. 2010 \[cited 2019 Aug 6\]. p. 1-51. Available from: http://www.audiology.org/publications-resources/document-library/central-auditory-processing-disorder 5. Lagacé J, Jutras B, Giguère C, Gagné J-P. Speech Perception in Noise: Exploring the Effect of Linguistic Context in Children With and Without Auditory Processing Disorder. Int J Audiol \[Internet\]. 2011;50(6):385-95. Available from: https://www.ncbi.nlm.nih.gov/pubmed/21599614 6. Rocha-Muniz CN, Zachi EC, Teixeira RAA, Ventura DF, Befi-Lopes DM, Schochat E. Association Between Language Development and Auditory Processing Disorders. Braz J Otorhinolaryngol \[Internet\]. 2014;80(3):231-6. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25153108 7. Allen P, Allan C. Auditory Processing Disorders: Relationship to Cognitive Processes and Underlying Auditory Neural Integrity. Int J Pediatr Otorhinolaryngol \[Internet\]. 2014;78(2):198-208. Available from: http://dx.doi.org/10.1016/j.ijporl.2013.10.048 8. British Society of Audiology. Practice Guidance. An Overview of Current Management of Auditory Processing Disorder (APD) \[Internet\]. British Society of Audiology. 2011 \[cited 2019 Aug 6\]. p. 1-60. Available from: http://www.thebsa.org.uk/docs/docsfromold/BSA\_APD\_Management\_1Aug11\_FINAL\_amended17Oct11.pdf 9. Johnston KN, John AB, Kreisman N V, Hall III JW, Crandell CC. Multiple Benefits of Personal FM System use by Children with Auditory Processing Disorder (APD). Int J Audiol \[Internet\]. 2009 Jan;48(6):371-83. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19925345 10. Smart JL, Purdy SC, Kelly AS. Impact of Personal Frequency Modulation Systems on Behavioral and Cortical Auditory Evoked Potential Measures of Auditory Processing and Classroom Listening in School-Aged Children with Auditory Processing Disorder. J Am Acad Audiol \[Internet\]. 2018;19:1-19. Available from: http://www.ingentaconnect.com/content/10.3766/jaaa.16074

Interventions

DEVICERemote Microphone Hearing Aids

The ear receivers connect wirelessly with the microphone being worn by the teacher within a range of 25m.

Sponsors

GN Resound
CollaboratorOTHER
University College, London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

1. Normal audiogram. 2. Diagnosis of APD based on clinical tests administered by qualified audiologists as per the clinic's diagnosis protocol. 3. No neurological or pervasive disorder or developmental delay (e.g. Attention Deficit Hyperactivity Disorder, epilepsy, Autism Spectrum Disorder, Developmental Language Disorder, Down Syndrome). 4. Non-verbal cognitive ability score of 85 or greater. 5. Ages between 7-12 years. 6. Native English speakers. 7. No prior use of RMHAs.

Exclusion criteria

Any violation of the above conditions.

Design outcomes

Primary

MeasureTime frameDescription
Listening Inventory For Education Revised (LIFE-R) - Total ScoreBaseline to 6 monthsChildren questionnaire measured in raw scores. This is the total score of 9 questions on a likert scale from 0 to 5. Thus, this is the summed score. Therefore, minimum value 0, maximum value 45. Higher scores mean better outcome.
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Total Advantage ConditionBaseline to 6 monthsSpeech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Spatial Advantage ConditionBaseline to 6 monthsSpeech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Talker Advantage ConditionBaseline to 6 monthsSpeech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.
Listening in Spatialised Noise - Sentences Test (LiSN-S) - High-cue Speech Reception Threshold Condition6 monthsSpeech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.
Listening in Spatialised Noise - Sentences Test (LiSN-S) - Low-cue Speech Reception Threshold ConditionBaseline to 6 monthsSpeech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.

Secondary

MeasureTime frameDescription
Test of Everyday Attention for Children TEACh - Divided Auditory-Visual Attention SubscaleBaseline to 6 monthsA validated attention test to test children's auditory-visual attention. Measured on scaled scores. Minimum value 1, maximum value 19. Higher scores mean better outcome.
Test of Everyday Attention for Children TEACh - Sustained Auditory Attention SubscaleBaseline to 6 monthsA validated attention test to test children's auditory attention. Measured on scaled scores. Minimum value 1, maximum value 19. Higher scores mean better outcome.
Test of Everyday Attention for Children TEACh - Selective Visual Attention SubscaleBaseline to 6 monthsA validated attention test to test children's visual attention. Measured on scaled scores. Minimum value 1, maximum value 19. Higher scores mean better outcome.
Test of Everyday Attention for Children TEACh - Divided Auditory Attention SubscaleBaseline to 6 monthsA validated attention test to test children's auditory attention. Measured on scaled scores. Minimum value 1, maximum value 19. Higher scores mean better outcome.

Other

MeasureTime frameDescription
Children's Auditory Performance Scale - Multiple Inputs SubscaleBaseline to 6 monthsParental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.
Screening Instrument For Targeting Educational Risk Performance Scale - Attention Subscale6 monthsRaw unstandardised score measured in Likert Scale (5 scales). Minimum score is 1, maximum score is 5. Higher score means better outcome. The three Attention Subscales are averaged to create one combined score.
The Children's Communication Checklist - 2 - Non-Standard Language Composite ScoreBaseline to 6 monthsParental questionnaire. Average composite of scaled scores are used to calculate the outcome, so units are scaled scores. Maximum value is 1, maximum value is 19. Higher score means better outcome.
The Children's Communication Checklist - 2 - Standard Language Composite Score6 monthsParental questionnaire. Average composite of scaled scores are used to calculate the outcome, so units are scaled scores. Maximum value is 1, maximum value is 19. Higher score means better outcome.
Children's Auditory Performance Scale - Auditory Attention Span SubscaleBaseline to 6 monthsParental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.
Children's Auditory Performance Scale - Noise SubscaleBaseline to 6 monthsParental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.
Children's Auditory Performance Scale - Auditory Memory Sequencing SubscaleBaseline to 6 monthsParental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.

Participant flow

Participants by arm

ArmCount
APD Control Group
Comprised 13 children diagnosed with APD and rdid not receive an intervention.
13
APD Intervention Group
Comprised 13 children diagnosed with APD and received the Remote Microphone Hearing Aid intervention right after baseline and for 6 months.
13
Total26

Baseline characteristics

CharacteristicAPD Intervention GroupTotalAPD Control Group
Age, Continuous115 Months
STANDARD_DEVIATION 16.1
115 Months
STANDARD_DEVIATION 15.9
116 Months
STANDARD_DEVIATION 16.3
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United Kingdom
13 participants26 participants13 participants
Sex: Female, Male
Female
4 Participants8 Participants4 Participants
Sex: Female, Male
Male
9 Participants18 Participants9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 130 / 13
other
Total, other adverse events
0 / 130 / 13
serious
Total, serious adverse events
0 / 130 / 13

Outcome results

Primary

Listening in Spatialised Noise - Sentences Test (LiSN-S) - High-cue Speech Reception Threshold Condition

Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.

Time frame: 6 months

Population: One outlier in the intervention group was found. Outlier was removed as participant had decreased focus and difficulty remaining seated during this condition.

ArmMeasureGroupValue (MEAN)Dispersion
APD Control GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - High-cue Speech Reception Threshold ConditionBaseline-0.83 z scoresStandard Deviation 1.45
APD Control GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - High-cue Speech Reception Threshold Condition3 months-0.70 z scoresStandard Deviation 1.34
APD Control GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - High-cue Speech Reception Threshold Condition6 months-1.23 z scoresStandard Deviation 1.82
APD Intervention GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - High-cue Speech Reception Threshold ConditionBaseline-1.27 z scoresStandard Deviation 1.02
APD Intervention GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - High-cue Speech Reception Threshold Condition3 months-0.60 z scoresStandard Deviation 1.08
APD Intervention GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - High-cue Speech Reception Threshold Condition6 months-0.68 z scoresStandard Deviation 1.66
Primary

Listening in Spatialised Noise - Sentences Test (LiSN-S) - Low-cue Speech Reception Threshold Condition

Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.

Time frame: Baseline to 6 months

ArmMeasureGroupValue (MEAN)Dispersion
APD Control GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Low-cue Speech Reception Threshold ConditionBaseline-0.56 z scoresStandard Error 0.9
APD Control GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Low-cue Speech Reception Threshold Condition3 months-0.46 z scoresStandard Error 1.43
APD Control GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Low-cue Speech Reception Threshold Condition6 months-1.38 z scoresStandard Error 3.33
APD Intervention GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Low-cue Speech Reception Threshold ConditionBaseline-0.99 z scoresStandard Error 1.12
APD Intervention GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Low-cue Speech Reception Threshold Condition3 months-0.63 z scoresStandard Error 1.61
APD Intervention GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Low-cue Speech Reception Threshold Condition6 months-1.05 z scoresStandard Error 1.51
Primary

Listening in Spatialised Noise - Sentences Test (LiSN-S) - Spatial Advantage Condition

Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.

Time frame: Baseline to 6 months

ArmMeasureGroupValue (MEAN)Dispersion
APD Control GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Spatial Advantage ConditionBaseline-1.50 z scoresStandard Deviation 1.54
APD Control GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Spatial Advantage Condition3 months-1.31 z scoresStandard Deviation 1.41
APD Control GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Spatial Advantage Condition6 months-0.98 z scoresStandard Deviation 1.76
APD Intervention GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Spatial Advantage ConditionBaseline-0.97 z scoresStandard Deviation 1.07
APD Intervention GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Spatial Advantage Condition3 months-0.99 z scoresStandard Deviation 1.57
APD Intervention GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Spatial Advantage Condition6 months-0.53 z scoresStandard Deviation 1.35
Primary

Listening in Spatialised Noise - Sentences Test (LiSN-S) - Talker Advantage Condition

Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.

Time frame: Baseline to 6 months

ArmMeasureGroupValue (MEAN)Dispersion
APD Control GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Talker Advantage ConditionBaseline-1.01 z scoresStandard Deviation 1.14
APD Control GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Talker Advantage Condition3 months-0.32 z scoresStandard Deviation 1
APD Control GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Talker Advantage Condition6 months-0.44 z scoresStandard Deviation 1.11
APD Intervention GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Talker Advantage ConditionBaseline-0.84 z scoresStandard Deviation 0.8
APD Intervention GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Talker Advantage Condition3 months-0.59 z scoresStandard Deviation 0.82
APD Intervention GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Talker Advantage Condition6 months-0.68 z scoresStandard Deviation 0.93
Primary

Listening in Spatialised Noise - Sentences Test (LiSN-S) - Total Advantage Condition

Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.

Time frame: Baseline to 6 months

Population: One outlier in the intervention group was found. Outlier was removed as participant had decreased focus and difficulty remaining seated during this condition.

ArmMeasureGroupValue (MEAN)Dispersion
APD Control GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Total Advantage ConditionBaseline-0.56 z scoresStandard Deviation 1.34
APD Control GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Total Advantage Condition3 months-0.52 z scoresStandard Deviation 1.28
APD Control GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Total Advantage Condition6 months-0.63 z scoresStandard Deviation 1.07
APD Intervention GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Total Advantage ConditionBaseline-0.94 z scoresStandard Deviation 1.12
APD Intervention GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Total Advantage Condition3 months-0.47 z scoresStandard Deviation 1.06
APD Intervention GroupListening in Spatialised Noise - Sentences Test (LiSN-S) - Total Advantage Condition6 months-0.30 z scoresStandard Deviation 1.28
Primary

Listening Inventory For Education Revised (LIFE-R) - Total Score

Children questionnaire measured in raw scores. This is the total score of 9 questions on a likert scale from 0 to 5. Thus, this is the summed score. Therefore, minimum value 0, maximum value 45. Higher scores mean better outcome.

Time frame: Baseline to 6 months

Population: An outlier at the 3-month time-point (at -3.25 SDs) was removed

ArmMeasureGroupValue (MEAN)Dispersion
APD Control GroupListening Inventory For Education Revised (LIFE-R) - Total ScoreBaseline30.91 Units on a scaleStandard Deviation 4.46
APD Control GroupListening Inventory For Education Revised (LIFE-R) - Total Score3 months33.33 Units on a scaleStandard Deviation 5.59
APD Control GroupListening Inventory For Education Revised (LIFE-R) - Total Score6 months30.83 Units on a scaleStandard Deviation 5.06
APD Intervention GroupListening Inventory For Education Revised (LIFE-R) - Total ScoreBaseline28.30 Units on a scaleStandard Deviation 7.44
APD Intervention GroupListening Inventory For Education Revised (LIFE-R) - Total Score3 months35.61 Units on a scaleStandard Deviation 3.45
APD Intervention GroupListening Inventory For Education Revised (LIFE-R) - Total Score6 months33.30 Units on a scaleStandard Deviation 7.66
Secondary

Test of Everyday Attention for Children TEACh - Divided Auditory Attention Subscale

A validated attention test to test children's auditory attention. Measured on scaled scores. Minimum value 1, maximum value 19. Higher scores mean better outcome.

Time frame: Baseline to 6 months

ArmMeasureGroupValue (MEAN)Dispersion
APD Control GroupTest of Everyday Attention for Children TEACh - Divided Auditory Attention SubscaleBaseline9.15 scaled scoresStandard Deviation 3.13
APD Control GroupTest of Everyday Attention for Children TEACh - Divided Auditory Attention Subscale3 months8.61 scaled scoresStandard Deviation 4.21
APD Control GroupTest of Everyday Attention for Children TEACh - Divided Auditory Attention Subscale6 months8.69 scaled scoresStandard Deviation 4.17
APD Intervention GroupTest of Everyday Attention for Children TEACh - Divided Auditory Attention SubscaleBaseline6.53 scaled scoresStandard Deviation 3.12
APD Intervention GroupTest of Everyday Attention for Children TEACh - Divided Auditory Attention Subscale3 months6.76 scaled scoresStandard Deviation 2.55
APD Intervention GroupTest of Everyday Attention for Children TEACh - Divided Auditory Attention Subscale6 months6.07 scaled scoresStandard Deviation 3.17
Secondary

Test of Everyday Attention for Children TEACh - Divided Auditory-Visual Attention Subscale

A validated attention test to test children's auditory-visual attention. Measured on scaled scores. Minimum value 1, maximum value 19. Higher scores mean better outcome.

Time frame: Baseline to 6 months

ArmMeasureGroupValue (MEAN)Dispersion
APD Control GroupTest of Everyday Attention for Children TEACh - Divided Auditory-Visual Attention Subscale3 months5.23 scaled scoresStandard Deviation 2.83
APD Control GroupTest of Everyday Attention for Children TEACh - Divided Auditory-Visual Attention SubscaleBaseline6.61 scaled scoresStandard Deviation 3.17
APD Control GroupTest of Everyday Attention for Children TEACh - Divided Auditory-Visual Attention Subscale6 months5.92 scaled scoresStandard Deviation 3.25
APD Intervention GroupTest of Everyday Attention for Children TEACh - Divided Auditory-Visual Attention SubscaleBaseline2.38 scaled scoresStandard Deviation 2.39
APD Intervention GroupTest of Everyday Attention for Children TEACh - Divided Auditory-Visual Attention Subscale3 months5.15 scaled scoresStandard Deviation 3.67
APD Intervention GroupTest of Everyday Attention for Children TEACh - Divided Auditory-Visual Attention Subscale6 months5.76 scaled scoresStandard Deviation 2.16
Secondary

Test of Everyday Attention for Children TEACh - Selective Visual Attention Subscale

A validated attention test to test children's visual attention. Measured on scaled scores. Minimum value 1, maximum value 19. Higher scores mean better outcome.

Time frame: Baseline to 6 months

ArmMeasureGroupValue (MEAN)Dispersion
APD Control GroupTest of Everyday Attention for Children TEACh - Selective Visual Attention SubscaleBaseline9.69 scaled scoresStandard Deviation 2.01
APD Control GroupTest of Everyday Attention for Children TEACh - Selective Visual Attention Subscale3 months10.30 scaled scoresStandard Deviation 3.61
APD Control GroupTest of Everyday Attention for Children TEACh - Selective Visual Attention Subscale6 months10.92 scaled scoresStandard Deviation 1.93
APD Intervention GroupTest of Everyday Attention for Children TEACh - Selective Visual Attention SubscaleBaseline6.00 scaled scoresStandard Deviation 2.85
APD Intervention GroupTest of Everyday Attention for Children TEACh - Selective Visual Attention Subscale3 months8.30 scaled scoresStandard Deviation 2.71
APD Intervention GroupTest of Everyday Attention for Children TEACh - Selective Visual Attention Subscale6 months9.61 scaled scoresStandard Deviation 2.32
Secondary

Test of Everyday Attention for Children TEACh - Sustained Auditory Attention Subscale

A validated attention test to test children's auditory attention. Measured on scaled scores. Minimum value 1, maximum value 19. Higher scores mean better outcome.

Time frame: Baseline to 6 months

ArmMeasureGroupValue (MEAN)Dispersion
APD Control GroupTest of Everyday Attention for Children TEACh - Sustained Auditory Attention SubscaleBaseline9.76 scaled scoresStandard Deviation 4
APD Control GroupTest of Everyday Attention for Children TEACh - Sustained Auditory Attention Subscale3 months7.76 scaled scoresStandard Deviation 3.67
APD Control GroupTest of Everyday Attention for Children TEACh - Sustained Auditory Attention Subscale6 months8.23 scaled scoresStandard Deviation 4.22
APD Intervention GroupTest of Everyday Attention for Children TEACh - Sustained Auditory Attention SubscaleBaseline6.30 scaled scoresStandard Deviation 2.62
APD Intervention GroupTest of Everyday Attention for Children TEACh - Sustained Auditory Attention Subscale3 months6.61 scaled scoresStandard Deviation 3.84
APD Intervention GroupTest of Everyday Attention for Children TEACh - Sustained Auditory Attention Subscale6 months5.76 scaled scoresStandard Deviation 1.87
Other Pre-specified

Children's Auditory Performance Scale - Auditory Attention Span Subscale

Parental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.

Time frame: Baseline to 6 months

ArmMeasureGroupValue (MEAN)Dispersion
APD Control GroupChildren's Auditory Performance Scale - Auditory Attention Span SubscaleBaseline-1.34 Units on a scaleStandard Deviation 0.86
APD Control GroupChildren's Auditory Performance Scale - Auditory Attention Span Subscale3 months-1.62 Units on a scaleStandard Deviation 1.06
APD Control GroupChildren's Auditory Performance Scale - Auditory Attention Span Subscale6 months-1.46 Units on a scaleStandard Deviation 1.04
APD Intervention GroupChildren's Auditory Performance Scale - Auditory Attention Span SubscaleBaseline-1.84 Units on a scaleStandard Deviation 1.16
APD Intervention GroupChildren's Auditory Performance Scale - Auditory Attention Span Subscale3 months-1.57 Units on a scaleStandard Deviation 0.93
APD Intervention GroupChildren's Auditory Performance Scale - Auditory Attention Span Subscale6 months-1.77 Units on a scaleStandard Deviation 1.17
Other Pre-specified

Children's Auditory Performance Scale - Auditory Memory Sequencing Subscale

Parental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.

Time frame: Baseline to 6 months

ArmMeasureGroupValue (MEAN)Dispersion
APD Control GroupChildren's Auditory Performance Scale - Auditory Memory Sequencing SubscaleBaseline-1.77 Units on a scaleStandard Deviation 1.15
APD Control GroupChildren's Auditory Performance Scale - Auditory Memory Sequencing Subscale3 months-2.24 Units on a scaleStandard Deviation 1.3
APD Control GroupChildren's Auditory Performance Scale - Auditory Memory Sequencing Subscale6 months-2.14 Units on a scaleStandard Deviation 1.35
APD Intervention GroupChildren's Auditory Performance Scale - Auditory Memory Sequencing SubscaleBaseline-2.63 Units on a scaleStandard Deviation 1.53
APD Intervention GroupChildren's Auditory Performance Scale - Auditory Memory Sequencing Subscale3 months-2.06 Units on a scaleStandard Deviation 1.33
APD Intervention GroupChildren's Auditory Performance Scale - Auditory Memory Sequencing Subscale6 months-2.51 Units on a scaleStandard Deviation 1.41
Other Pre-specified

Children's Auditory Performance Scale - Multiple Inputs Subscale

Parental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.

Time frame: Baseline to 6 months

ArmMeasureGroupValue (MEAN)Dispersion
APD Control GroupChildren's Auditory Performance Scale - Multiple Inputs SubscaleBaseline-1.31 Units on a scaleStandard Deviation 0.99
APD Control GroupChildren's Auditory Performance Scale - Multiple Inputs Subscale3 months-1.33 Units on a scaleStandard Deviation 1.09
APD Control GroupChildren's Auditory Performance Scale - Multiple Inputs Subscale6 months-1.05 Units on a scaleStandard Deviation 1.14
APD Intervention GroupChildren's Auditory Performance Scale - Multiple Inputs SubscaleBaseline-1.62 Units on a scaleStandard Deviation 1.21
APD Intervention GroupChildren's Auditory Performance Scale - Multiple Inputs Subscale3 months-1.21 Units on a scaleStandard Deviation 1
APD Intervention GroupChildren's Auditory Performance Scale - Multiple Inputs Subscale6 months-1.33 Units on a scaleStandard Deviation 1.41
Other Pre-specified

Children's Auditory Performance Scale - Noise Subscale

Parental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.

Time frame: Baseline to 6 months

ArmMeasureGroupValue (MEAN)Dispersion
APD Control GroupChildren's Auditory Performance Scale - Noise SubscaleBaseline-2.85 units on a scaleStandard Deviation 1.01
APD Control GroupChildren's Auditory Performance Scale - Noise Subscale3 months-2.36 units on a scaleStandard Deviation 1.31
APD Control GroupChildren's Auditory Performance Scale - Noise Subscale6 months-2.19 units on a scaleStandard Deviation 1.07
APD Intervention GroupChildren's Auditory Performance Scale - Noise SubscaleBaseline-3.29 units on a scaleStandard Deviation 0.89
APD Intervention GroupChildren's Auditory Performance Scale - Noise Subscale3 months-2.82 units on a scaleStandard Deviation 0.83
APD Intervention GroupChildren's Auditory Performance Scale - Noise Subscale6 months-2.95 units on a scaleStandard Deviation 0.97
Other Pre-specified

Screening Instrument For Targeting Educational Risk Performance Scale - Attention Subscale

Raw unstandardised score measured in Likert Scale (5 scales). Minimum score is 1, maximum score is 5. Higher score means better outcome. The three Attention Subscales are averaged to create one combined score.

Time frame: 6 months

Population: Only 5 questionnaires given to teachers were returned, all from the intervention group. The data for these 5 questionnaires are presented in the APD Group 2, as all 5 cases are from that group only. Group 1 has no data.

ArmMeasureGroupValue (MEAN)Dispersion
APD Intervention GroupScreening Instrument For Targeting Educational Risk Performance Scale - Attention SubscaleBaseline2.33 units on a scaleStandard Deviation 0.59
APD Intervention GroupScreening Instrument For Targeting Educational Risk Performance Scale - Attention Subscale6 months2.79 units on a scaleStandard Deviation 1
Other Pre-specified

The Children's Communication Checklist - 2 - Non-Standard Language Composite Score

Parental questionnaire. Average composite of scaled scores are used to calculate the outcome, so units are scaled scores. Maximum value is 1, maximum value is 19. Higher score means better outcome.

Time frame: Baseline to 6 months

Population: One parent from intervention group did not complete any of the questionnaires, hence intervention group number analysed was 12.

ArmMeasureGroupValue (MEAN)Dispersion
APD Control GroupThe Children's Communication Checklist - 2 - Non-Standard Language Composite Score6 months6.61 scaled scoresStandard Deviation 3.06
APD Control GroupThe Children's Communication Checklist - 2 - Non-Standard Language Composite ScoreBaseline6.25 scaled scoresStandard Deviation 2.82
APD Control GroupThe Children's Communication Checklist - 2 - Non-Standard Language Composite Score3 months6.38 scaled scoresStandard Deviation 2.87
APD Intervention GroupThe Children's Communication Checklist - 2 - Non-Standard Language Composite ScoreBaseline6.19 scaled scoresStandard Deviation 2.66
APD Intervention GroupThe Children's Communication Checklist - 2 - Non-Standard Language Composite Score3 months6.08 scaled scoresStandard Deviation 2.6
APD Intervention GroupThe Children's Communication Checklist - 2 - Non-Standard Language Composite Score6 months5.70 scaled scoresStandard Deviation 2.83
Other Pre-specified

The Children's Communication Checklist - 2 - Standard Language Composite Score

Parental questionnaire. Average composite of scaled scores are used to calculate the outcome, so units are scaled scores. Maximum value is 1, maximum value is 19. Higher score means better outcome.

Time frame: 6 months

Population: One parent from intervention group did not complete any of the questionnaires, hence intervention group number analysed was 12.

ArmMeasureGroupValue (MEAN)Dispersion
APD Control GroupThe Children's Communication Checklist - 2 - Standard Language Composite ScoreBaseline5.82 scaled scoresStandard Deviation 2.65
APD Control GroupThe Children's Communication Checklist - 2 - Standard Language Composite Score3 months6.03 scaled scoresStandard Deviation 2.71
APD Control GroupThe Children's Communication Checklist - 2 - Standard Language Composite Score6 months6.50 scaled scoresStandard Deviation 2.84
APD Intervention GroupThe Children's Communication Checklist - 2 - Standard Language Composite ScoreBaseline5.44 scaled scoresStandard Deviation 2.56
APD Intervention GroupThe Children's Communication Checklist - 2 - Standard Language Composite Score3 months5.39 scaled scoresStandard Deviation 2.88
APD Intervention GroupThe Children's Communication Checklist - 2 - Standard Language Composite Score6 months5.58 scaled scoresStandard Deviation 2.35

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026