Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000509864
Ethics application status
Approved
Date submitted
24/02/2021
Date registered
30/04/2021
Date last updated
4/04/2022
Date data sharing statement initially provided
30/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Edith Cowan University Late Talkers Study: a statistical learning intervention for young children with late language emergence
Scientific title
Investigating the effect of a parent-administered cross-situational statistically-based word learning treatment on the acquisition of new words for children up to three years of age with late language emergence
Secondary ID [1] 303528 0
Nil known
Universal Trial Number (UTN)
U1111-1265-3525
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
developmental language disorder 320859 0
Condition category
Condition code
Physical Medicine / Rehabilitation 318678 318678 0 0
Speech therapy
Mental Health 318708 318708 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children that are late to acquire their first words are at high risk of ongoing language and developmental difficulties. This project aims to contribute to the body of research about the efficacy of parent-administered speech therapy, and to further evaluate the contributions of the 'ingredients' of therapy, such as dose and variability of input.

Design
This is a single subject (AB) (A = baseline and B = treatment) non-concurrent multiple baseline design, with replication across four participants.

Protocol
Each parent and child will attend:
• A baseline assessment session,
• An individual parent-training session
• 8 group parent-training sessions
• 3 video-observation sessions to assess treatment fidelity
• A post-treatment assessment session

Baseline Assessment Session
The baseline assessment session will be performed within the four weeks prior to the intervention. It will take approximately 45 minutes and include:
• An oral explanation of the study protocol, and a description of what parents and children will be asked to do
• An OZI (Australian English Communicative Development Inventory) will be completed by parents to establish baseline language learning abilities
• Two video recorded language samples, one with the parent and child and another with the child and a researcher. These will be used to corroborate the language survey results and to get a baseline of parent linguistic input.

Initial individual parent-training session
Parents will attend a one-hour individual parent-training session, within the four weeks prior to the intervention. This session will consist of:
• Written and verbal information about the study objectives and rationale for the study to be explained by the clinicians
• Parents to nominate vocabulary goals/words they would like their children to acquire during the course of treatment.
• Demonstration of the child-directed language therapy technique with high dose and grammatical and physical variability by the clinicians
• Parents will be instructed to conduct therapy twice per week for thirty minutes. During these sessions they will be aiming for as many presentations of the target word as possible, with a minimum of 64 doses. They will also be instructed to aim for high variability, both grammatical (different positions within a sentence) and physical (using different toys, materials).
• Opportunities to practice by the parent, both in a simulated (without child) and real-life (with their child) contexts
• Parents will be given information materials to take home which summarizes how to use language during the home treatment sessions. These will be created by the student Speech Pathologists and approved by Dr Meldrum and Ms Hunt before the sessions. These materials will contain activities and suggestions to promote high variability and high dose for the target words during the home treatment session.
• Parents will complete a pre-treatment acceptability questionnaire

Target and control word selection
After all parents have completed the individual parent-training sessions, the research team will select 10 target and control word pairs (20 words in total) to be used for all the children. To be selected, the words will not be present in any of the children’s expressive vocabularies, but receptively known by them, as reported in the OZI collected at the individual training sessions. Where possible, words will be included which the families have nominated as possible targets. Word pairs will be matched as closely as possible based on grammatical category (noun, verb, adjective etc), semantic category (food, vehicles, clothing etc), number of syllables and item trajectories on the Stanford Wordbank Item Trajectories for the child’s age. Words will then be randomly allocated to target or control words and in treatment order. Control words will be used as part of the training process. Both control and target words will be tested each week, and in as an outcome in the final session.

Parent group-training sessions
Parents and children will attend 8 group training sessions, one per week. There will be a maximum of 4 dyads of parents and children per group. Each session will last no longer than an hour and will include:
• Initial block of probes to assess production of all target and control words. Photos and spoken cloze phrases (e.g. what’s this?) will be provided in random order to elicit a spontaneous (i.e. not imitated) production.
• Parents will be given an OZI to update, reporting their child’s use of any new words (not only target and control words) each week.
• Home treatment diaries will be reviewed, which note how many home treatment sessions took place, the duration, and targets in order to determine adherence to protocol
• The clinicians will nominate three target words to be treated in the home treatment sessions during the next week.
• Parents will be instructed to conduct two sessions at home per week, each lasting approximately 30 minutes (during which they target the three target words).
• The clinician will demonstrate at least five different activities to feature the target words and ensure physical variability. Activities relevant to the target word may include playing with toys, making craft and looking at books. Activities will be designed by the student Speech Pathologists and approved by Dr Meldrum and Ms Hunt before the session.
• The clinician will demonstrate how to present the target word at least five different positions within an utterance (for grammatic variability). For example “That’s a duck! The duck is swimming in the pond. I want to pick up my duck and put him in his bed.”
• Parents will be reminded that the goal is to provide a minimum of 64 exemplars of a word, using the demonstrated techniques as much as possible within the home treatment session.
• Participants will be given opportunities to practice the activities and target word presentation with their child.
• Clinicians will provide gentle, guided feedback and encouragement, always focusing on achieving the goal of high dose and variability of target words in parent-to-child language. This will be akin to published protocols of parent training for Speech Pathology and based on adult learning principals, such as "Exploring Input Parameters in an Expressive Vocabulary Treatment With Late Talkers" Alt, et al. (2020); "Systematic review of the literature on the treatment of children with late language emergence" Cable & Domsch (2011); and "Association of Parent Training With Child Language Development: A Systematic Review and Meta-analysis" Roberts et al., (2019)
• Participants will be reminded to fill in the home treatment diary each time they conduct home treatment, recording the date, time spent, the target word and their perception of the experience (reasonableness).
• Parents will be given opportunities to discuss and describe their experiences in giving the intervention to the other parents and the clinician.
• Parents will be reminded to give no additional language intervention, other than the two 30-minute home sessions per week.
If at any time the family cannot participate, due to illness or child non-compliance at the session, then the family will be invited to add a session to the intervention schedule (8 sessions in total are required). The parent and/or the child may refuse to attend at any time without penalty. If they wish to withdraw, they will be asked if they will allow their data to be used in analysis or if they wish to withdraw their data completely. Information will be obtained about the reasons for withdrawal if possible (if the parents are willing and contactable to do so), to inform the feasibility and acceptability evaluation of the program.

Treatment fidelity sessions
After each group training session, one family will remain and participate in a treatment fidelity session for approximately 30 minutes. Each family will participate in 2 treatment fidelity sessions across the course of the trial. At these sessions, the parent will be instructed to complete the intervention with their child as they would usually do at home. Only the parent and child will be interacting, with the clinician only observing and ensuring adequate videotaping. Parents will be instructed that this will count as one of the two home sessions to be conducted that week, to ensure that all children receive the same number of intervention sessions per week.
The interaction will be videotaped with the aim of determining treatment fidelity. At a later time, the variability and dose of the target words will be measured, along with any child word productions and any production of the control words.

Post-Treatment Assessments
In the week after the group-training sessions have finished, participants and their parents will attend an individual post-treatment assessment, which will take approximately 45 minutes, and include the following activities:
• A final OZI will be completed by parents
• Two video recorded language samples, one with the parent and child and another with the child and a researcher to corroborate the language survey results and to measure parent linguistic input.
• The Intervention Acceptability questionnaire will be completed in written format by the parents, and a semi-structured interview of parents views.
• The Intervention Acceptability questionnaire will be completed in written format by the student clinician.


Study Personnel
Two final (4th) year Speech Pathology students will administer the intervention protocol (all clinician appointments listed above) under the direct supervision of Dr Meldrum and Ms Hunt who are both qualified Speech Pathologists.

Location
All appointments will take place at the School of Medical and Health Sciences, Edith Cowan University in Joondalup, Western Australia. Travel will be required by participants to this facility, and parking will be provided.
Intervention code [1] 319811 0
Behaviour
Intervention code [2] 319812 0
Treatment: Other
Comparator / control treatment
Control Words
Control group
Active

Outcomes
Primary outcome [1] 326623 0
Acquisition of treatment words compared to control words.
Measured using the Australian English Communicative Development Inventory (OZI) completed in weekly sessions , and in the post-treatment assessment session; child responses to probes in the group-training sessions; parent report in the weekly home treatment diaries; or observed by the clinicians in the group-training or treatment fidelity sessions.
Timepoint [1] 326623 0
Weekly, and within 2 weeks of the last week of treatment.
Secondary outcome [1] 392166 0
Acceptability of treatment to parents.
Measured using a study-specific Intervention Acceptability Questionnaire (based on TARF-R; Reimers,, Wacker & Cooper, 1991)
Timepoint [1] 392166 0
Within 2 weeks of the last week of treatment.
Secondary outcome [2] 393451 0
Acceptability of treatment to clinicians
Measured using a study-specific Intervention Acceptability Questionnaire (based on TARF-R; Reimers, Wacker & Cooper, 1991)
Timepoint [2] 393451 0
Within 2 weeks of the last week of treatment.
Secondary outcome [3] 393453 0
Treatment Protocol Fidelity
Measured by:
- Dosage and variability measured during video observation of parent/child interaction
- Total treatment time and number of treated words reported by parents from home treatment diaries
- Parent report of ease of administration, measured using a study-specific questionnaire and semi-structured interviews during, and in the post-intervention assessment session
Timepoint [3] 393453 0
Weekly, and in the post-intervention assessment session, within 2 weeks of the last week of treatment.
Secondary outcome [4] 393454 0
Demand
The number of eligible families who expressed interest in the study will be recorded in a database, and compared to the total number of eligible families who wanted to participate in the study, also recorded in a database. Reasons for not participating will be recorded.
Timepoint [4] 393454 0
Within 2 weeks of the last week of treatment.
Secondary outcome [5] 393602 0
Total number of new words acquired
Timepoint [5] 393602 0
Measured using the Australian English Communicative Development Inventory (OZI); child responses to probes in the group-training sessions; parent report in the weekly home treatment diaries; or observed by the clinicians in the group-training or treatment fidelity sessions.

Eligibility
Key inclusion criteria
Four English-speaking participants aged between 18 months – 3 years. The following criteria will be used to determine inclusion in the study:
i). Perform below age expectations according to the parent report survey, the OZI: Australian English Communicative Development Inventory <10th percentile),
ii). Say their existing words (if any) well enough for the clinicians to adequately judge future productions as word attempts, and
iii). Families willing to follow the treatment protocol.
iv). Families agree to not undertake any other speech pathology treatment during the course of the study.
Minimum age
18 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children will be excluded if they
i). are born preterm (<37 weeks)
ii). Speak a language other than English,
iii). Have any hearing or visual impairments, and
iv). Have a known diagnosed disability or disorder.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data Analysis
As this project has multiple components, the data analysis is broken into sections:

Demographics
Participant characteristics will be presented as descriptive data for each participant, including age, family history of speech and language, parent education and previous experience with allied health therapy.

Demand
The total number of eligible families who expressed interest in the study will be compared to the total number of eligible families who wanted to participate in the study and expressed as a percentage. Reasons for not participating (e.g. could not commit to treatment, did not have time) will be recorded. Both measures will give information about the demand for the intervention, and the broader acceptability of the study.

Treatment Fidelity
Home treatment diaries will be used to calculate the total treatment time and the number of treated words for each participant in order to measure treatment compliance. The sum of Likert-scale responses to ease of administration will be calculated to form a total score. Items will be coded so that a high rating (based on a score of 1 to 5 per items) suggests that the treatment was tolerable to administer.

Acceptability – parent and clinician
The sum of Likert-scale responses will be calculated to form a total acceptability score. Items will be coded so that a high rating (based on a score of 1 to 5 per items) is indicative of a favourable or more acceptable response. Qualitative analysis of open-ended questions will be performed using thematic analysis to identify themes in the responses from the group of parents. Free-text responses will be coded for main themes by one of the student clinicians and another researcher independent to the study from the School of Medical and Health Sciences at Edith Cowan University. Inter-rater reliability and coding discrepancies will be resolved by discussion until consensus can be reached.
In order to determine treatment protocol fidelity, the videotaped parent treatment fidelity sessions will be analysed and the total, mean, range, standard deviation and total percentage of sentence variability (declarative, exclamatory, interrogative and imperative sentences) and the total, mean, range and standard deviation of dose will be calculated for each participant.

Treatment efficacy
This is a single subject (AB) (A = baseline and B = treatment) non-concurrent multiple baseline design, with replication across four participants. The independent variables will be the dose of target and control words for each participant. The dependent variable will be the vocabulary growth for each participant, which is measured in multiple ways. Firstly, the acquisition of target and control words will be gathered through: a) weekly parent report; b) child production during the initial probes before every group session; and c) child production during every home and group session. This data will be used to calculate the effect size for the treatment and to compare the acquisition of target versus control words. Secondly, the vocabulary growth of untreated words (all words excluding target words) will be gathered from the two pre-treatment and post-treatment OZI, and will be used to calculate the rate of words learnt per week, giving an indication of generalisation of the treatment. To determine the effectiveness of the treatment, a between-phase and within-intervention-phase Tau-U pair wise analysis will be conducted, as well as visual analysis of the target words learnt compared to the control words learnt each week.
The sample size will not be sufficient to statistically examine for the relationship between treatment outcomes and other potentially relevant factors. However, a number of variables will be examined for trends which can be further explored in larger randomised trials. These variables include child age, parent Socioeconomic status, parent experience with allied health therapies and parent and clinician acceptability ratings of treatment. Treatment-specific factors such as average dose, treatment time and variability will also be examined for trends in their relationship to treatment outcomes for individual participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/05/2021
Actual
20/05/2021
Date of last participant enrolment
Anticipated
27/05/2021
Actual
27/05/2021
Date of last data collection
Anticipated
29/08/2021
Actual
3/09/2021
Sample size
Target
4
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 33257 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 307952 0
University
Name [1] 307952 0
Edith Cowan University
Country [1] 307952 0
Australia
Primary sponsor type
Individual
Name
Dr Suzanne Meldrum
Address
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Drive
Joondalup
WA 6027
Country
Australia
Secondary sponsor category [1] 308667 0
Individual
Name [1] 308667 0
Emily Hunt
Address [1] 308667 0
School of Medical Health Sciences
Edith Cowan University
270 Joondalup Drive
Joondalup
WA 6027
Country [1] 308667 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307942 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 307942 0
Ethics committee country [1] 307942 0
Australia
Date submitted for ethics approval [1] 307942 0
12/01/2021
Approval date [1] 307942 0
11/03/2021
Ethics approval number [1] 307942 0
2021-02166-MELDRUM

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109002 0
Dr Suzanne Meldrum
Address 109002 0
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Drive
Joondalup
WA 6027
Country 109002 0
Australia
Phone 109002 0
+61 8 6304 5101
Fax 109002 0
Email 109002 0
s.meldrum@ecu.edu.au
Contact person for public queries
Name 109003 0
Suzanne Meldrum
Address 109003 0
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Drive
Joondalup
WA 6027
Country 109003 0
Australia
Phone 109003 0
+61 8 6304 5101
Fax 109003 0
Email 109003 0
s.meldrum@ecu.edu.au
Contact person for scientific queries
Name 109004 0
Suzanne Meldrum
Address 109004 0
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Drive
Joondalup
WA 6027
Country 109004 0
Australia
Phone 109004 0
+61 8 6304 5101
Fax 109004 0
Email 109004 0
s.meldrum@ecu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not applied for ethical approval for this purpose.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10776Informed consent form    381486-(Uploaded-24-02-2021-16-19-53)-Study-related document.pdf
10777Informed consent form    381486-(Uploaded-24-02-2021-16-20-10)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.