AutismNCT04209452
Improving Working Memory of Children With Autism
A study testing Rehearsal strategy, Reinforcement and Rehearsal strategy and reinforcement in people with Autism, run by Arizona State University at 3 sites in China.
Trial summary
Existing findings suggest that challenges in working memory (WM) of children with autism are common (Habib, Pollick, Melville, \& 2019). The WM malfunction can last across the lifespan and individuals with autism exhibit large WM impairments in both phonological and visuospatial domains (Habib, Harris, Pollick \&… Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Autism
- What is being tested?
- Rehearsal strategy, Reinforcement and Rehearsal strategy and reinforcement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesChina
- Study dates
- 15 Jan 2020to 10 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- have a diagnosis of autism
- have an echoic repertoire
Who cannot join
- problem behavior or noncompliance
Trial locations and contacts
3 sites in 1 country.
China3 sites
Jingdezhen Kindkids Autism Rehabilitation and Training Center
Jingdezhen, Jiangxi
Shanghai Xuhui Clover Children Healthy Garden
Shanghai
Sunshine Special Education Center
Taizhou, Zhejiang
About this study
Official title: Improving Working Memory of Children With Autism Through Instruction on Rehearsal Strategy and Reinforcement
Existing findings suggest that challenges in working memory (WM) of children with autism are common (Habib, Pollick, Melville, \& 2019). The WM malfunction can last across the lifespan and individuals with autism exhibit large WM impairments in both phonological and visuospatial domains (Habib, Harris, Pollick \& Melville, 2019). Despite the well-documented effects of WM impairments, little research has been dedicated to strategies for improving the working memory of children with autism.
Previous research found that individuals who verbally repeat a previously presented stimulus (i.e., rehearsal) tended to perform better than those who do not rehearse (Bebko, Rhee, Ncube, \& Dahary, 2017; Joseph, Steele, Meyer, \& Tager-Flusberg, 2005). In addition, among studies that investigated WM in children with autism, Baltruschat et al (2011a; 2011; 2012) conduct studies using positive reinforcement. Their results reveal that the positive reinforcement appeared to have produced better working memory.
The present study intends to investigate if training children with autism to use rehearsal strategy would improve their working memory. In addition, the investigators are also interested to see if reinforcement is a critical component that may provide additive effects beyond the effects of rehearsal. The investigators intend to randomly assign children to four different conditions: control, rehearsal, reinforcement, and rehearsal + reinforcement conditions. The results of this study should provide empirical evidence for practitioners to improve WM in children with autism.
Read the detailed description
Prescreening:
The purpose of prescreening is to determine the IQ and functioning level of the participants. The investigators will administrate IQ tests in which the participants will complete a series of tasks such as pointing to images/objects, placing objects, and answer questions upon instruction. The investigators will interview parents regarding their children's levels of functioning as well as their information (e.g., level of education). Additionally, the investigators will also assess the number of digits (digit span) and delay for each participant as the participants may function at different levels. Members of the research team will test a combination of different digit span and delays for each participant to assess how many digits in a sequence (i.e., digit span) they can remember and how long (i.e., delay) they can remember the digit sequence.
Pretest:
A pretest trial starts when a teacher asks a participant to repeat a sequence of numbers and a sequence of nonsense words. The teacher will say one number or one nonsense word at a time, wait for a predetermined interval, and ask the participant to report the numbers or the words in the exact sequence as they hear. The trial ends after the participant recalls correctly or incorrectly, or if the participant does not produce a recall after 5 s. The teacher will not provide any verbal feedback for participants' responses during the pretest. The investigators will conduct pretest for approximately one week. During the pretest, teacher will record exactly what the participant says.
Random assignment:
After pretest, the participants will be randomly assigned to one of four groups: control, rehearsal, reinforcement, and rehearsal + reinforcement groups.
Control group Participants in this group will not receive any intervention during the study.
Rehearsal group Participants in this group will receive rehearsal intervention. The intervention will last approximately 2-3 weeks depending on the participant performance. Sessions will be conducted daily, and each will include 10 trials.
A preference assessment will be conducted to determine the reinforcer before each session. Participants will be asked to choose a reinforcer that they would like to receive during the instruction. In a rehearsal trial, the teacher will verbally present numbers in a sequence. After a number is verbally presented, the teacher will prompt the participant to rehearse (repeat) the number being said as well as all previous numbers. Correct rehearsal will be followed by a reinforcer (e.g., an edible item with verbal praise). Once the participant can independently rehearse the number(s), the prompts for verbal rehearsal will only be provided when he or she does not start providing a rehearsal within 1 s. The reinforcer will then only be given for correct unprompted verbal rehearsal. If the participant does not provide any verbal rehearsals or verbalize incorrect numbers, the instructor will repeat the process and ask the participant to rehearse the numbers again. After the predetermined delay after the correct verbal rehearsal, the participant will be asked to recall the number sequence. No reinforcement or feedback will be provided.
Reinforcement group A preference assessment will be conducted to determine the reinforcer before each session. Participants will be asked to choose a reinforcer that they would like to receive during the instruction. Before each trial, the teacher will verbally instruct the participant to try to remember the numbers and that the reinforcer will be delivered upon the correct recall. In each trial, the teacher will verbally present numbers in a sequence. After a while, the teacher will ask the participant to repeat the numbers in the sequence. If the participant correctly repeats the numbers, the reinforcer will be given. If the numbers are repeated incorrectly, the reinforcement will not be given. No other instruction will be given (e.g., on rehearsal strategy).
Rehearsal + reinforcement group The participants in this group will receive rehearsal intervention and reinforcement in the same manner as the participants in the rehearsal group as well as in the reinforcement group.
Posttest:
Posttest procedure and data collection will be the same as those during pretest.
- Conditions
- Autism
- Being tested
- Rehearsal strategy, Reinforcement, Rehearsal strategy and reinforcement
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehearsal strategyBehavioural
Teaching children to cumulatively rehearse numbers as they are being said.
ReinforcementBehavioural
Providing reinforcement for correct recall after a delay.
Rehearsal strategy and reinforcementBehavioural
Teaching children to cumulatively rehearse numbers as they are being said, AND providing reinforcement for correct recall after a delay.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention will be provided for participants enrolled in the control group. |
| Rehearsal | Experimental | Participants will receive instruction on rehearsal strategy. Receives: Behavioral: Rehearsal strategy |
| Reinforcement | Experimental | Participants will receive reinforcement for correct recall. Receives: Behavioral: Reinforcement |
| Rehearsal + Reinforcement | Experimental | The participants in this group will receive instruction on rehearsal strategy and reinforcement for correct recall. Receives: Behavioral: Rehearsal strategy and reinforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percent recall
Participants will hear a sequence of digits or words (range from 1 to 9 stimuli) and then will be asked to recall the serial order after a delay (e.g., 9, 12, or 15 s). Percent correct recall of serial order will be calculated for all sequences as well as for each sequence size and delay. Change of percent recall from before, during, and after the intervention will be measured.
Measured: Before, during, and up to 2 weeks after intervention.
Secondary outcomes (1)
Change in percent strategy used.
Percentage of trials in which a rehearsal strategy or another memory strategy is used will be calculated during and after the intervention. We will code the strategies used by participants and calculate the percentage of trials in which a rehearsal strategy or another strategy they used.
Measured: During the intervention, and up to 2 weeks after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start15 Jan 2020
- Primary completion10 Nov 2020
- Study completion10 Nov 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Xuhui Clover Children Healthy Garden, Jingdezhen Kindkids Autism Rehabilitation and Training Center, Sunshine Special Education Center
- Responsible party
- Sponsor
- Investigators
- Chengan Yuan, PhD, Principal investigator, Arizona State UniversityErin Rotheram-Fuller, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209452
- Sponsor's protocol ID
- STUDY00010960
- Status last verified
- Nov 2020
- First submitted
- 9 Dec 2019
- Last updated
- 12 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Habib A, Harris L, Pollick F, Melville C. A meta-analysis of working memory in individuals with autism spectrum disorders. PLoS One. 2019 Apr 30;14(4):e0216198. doi: 10.1371/journal.pone.0216198. eCollection 2019.
PubMed 31039192Joseph RM, Steele SD, Meyer E, Tager-Flusberg H. Self-ordered pointing in children with autism: failure to use verbal mediation in the service of working memory? Neuropsychologia. 2005;43(10):1400-11. doi: 10.1016/j.neuropsychologia.2005.01.010. Epub 2005 Feb 17.
PubMed 15989932Baltruschat L, Hasselhorn M, Tarbox J, Dixon D R, Najdowski AC, Mullins R D, Gould, ER. Addressing working memory in children with autism through behavioral intervention. Research in Autism Spectrum Disorders. 2011;5(1): 267-76. doi: 10.1016/j.rasd.2010.04.008
Bebko JM, Rhee T, Ncube BL, Dahary H. Effectiveness and Retention of Teaching Memory Strategy Use to Children With Autism Spectrum Disorder. Canadian Journal of School Psychology. 2017;32(3-4): 244-64. doi: 10.1177/0829573517699332
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Working Memory of Children With Autism Through Instruction on Rehearsal Strategy and Reinforcement
- ClinicalTrials.gov ID
- NCT04209452
- Acronym / sponsor ID
- STUDY00010960
- Conditions
- Autism
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Shanghai Xuhui Clover Children Healthy Garden, Jingdezhen Kindkids Autism Rehabilitation and Training Center, Sunshine Special Education Center
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Existing findings suggest that challenges in working memory (WM) of children with autism are common (Habib, Pollick, Melville, \& 2019). The WM malfunction can last across the lifespan and individuals with autism exhibit large WM impairments in both phonological and visuospatial domains (Habib, Harris, Pollick \& Melville, 2019). Despite the well-documented effects of WM impairments, little research has been dedicated to strategies for improving the working memory of children with autism.
Previous research found that individuals who verbally repeat a previously presented stimulus (i.e., rehearsal) tended to perform better than those who do not rehearse (Bebko, Rhee, Ncube, \& Dahary, 2017; Joseph, Steele, Meyer, \& Tager-Flusberg, 2005). In addition, among studies that investigated WM in children with autism, Baltruschat et al (2011a; 2011; 2012) conduct studies using positive reinforcement. Their results reveal that the positive reinforcement appeared to have produced better working memory.
The present study intends to investigate if training children with autism to use rehearsal strategy would improve their working memory. In addition, the investigators are also interested to see if reinforcement is a critical component that may provide additive effects beyond the effects of rehearsal. The investigators intend to randomly assign children to four different conditions: control, rehearsal, reinforcement, and rehearsal + reinforcement conditions. The results of this study should provide empirical evidence for practitioners to improve WM in children with autism.
Detailed description
Prescreening:
The purpose of prescreening is to determine the IQ and functioning level of the participants. The investigators will administrate IQ tests in which the participants will complete a series of tasks such as pointing to images/objects, placing objects, and answer questions upon instruction. The investigators will interview parents regarding their children's levels of functioning as well as their information (e.g., level of education). Additionally, the investigators will also assess the number of digits (digit span) and delay for each participant as the participants may function at different levels. Members of the research team will test a combination of different digit span and delays for each participant to assess how many digits in a sequence (i.e., digit span) they can remember and how long (i.e., delay) they can remember the digit sequence.
Pretest:
A pretest trial starts when a teacher asks a participant to repeat a sequence of numbers and a sequence of nonsense words. The teacher will say one number or one nonsense word at a time, wait for a predetermined interval, and ask the participant to report the numbers or the words in the exact sequence as they hear. The trial ends after the participant recalls correctly or incorrectly, or if the participant does not produce a recall after 5 s. The teacher will not provide any verbal feedback for participants' responses during the pretest. The investigators will conduct pretest for approximately one week. During the pretest, teacher will record exactly what the participant says.
Random assignment:
After pretest, the participants will be randomly assigned to one of four groups: control, rehearsal, reinforcement, and rehearsal + reinforcement groups.
Control group Participants in this group will not receive any intervention during the study.
Rehearsal group Participants in this group will receive rehearsal intervention. The intervention will last approximately 2-3 weeks depending on the participant performance. Sessions will be conducted daily, and each will include 10 trials.
A preference assessment will be conducted to determine the reinforcer before each session. Participants will be asked to choose a reinforcer that they would like to receive during the instruction. In a rehearsal trial, the teacher will verbally present numbers in a sequence. After a number is verbally presented, the teacher will prompt the participant to rehearse (repeat) the number being said as well as all previous numbers. Correct rehearsal will be followed by a reinforcer (e.g., an edible item with verbal praise). Once the participant can independently rehearse the number(s), the prompts for verbal rehearsal will only be provided when he or she does not start providing a rehearsal within 1 s. The reinforcer will then only be given for correct unprompted verbal rehearsal. If the participant does not provide any verbal rehearsals or verbalize incorrect numbers, the instructor will repeat the process and ask the participant to rehearse the numbers again. After the predetermined delay after the correct verbal rehearsal, the participant will be asked to recall the number sequence. No reinforcement or feedback will be provided.
Reinforcement group A preference assessment will be conducted to determine the reinforcer before each session. Participants will be asked to choose a reinforcer that they would like to receive during the instruction. Before each trial, the teacher will verbally instruct the participant to try to remember the numbers and that the reinforcer will be delivered upon the correct recall. In each trial, the teacher will verbally present numbers in a sequence. After a while, the teacher will ask the participant to repeat the numbers in the sequence. If the participant correctly repeats the numbers, the reinforcer will be given. If the numbers are repeated incorrectly, the reinforcement will not be given. No other instruction will be given (e.g., on rehearsal strategy).
Rehearsal + reinforcement group The participants in this group will receive rehearsal intervention and reinforcement in the same manner as the participants in the rehearsal group as well as in the reinforcement group.
Posttest:
Posttest procedure and data collection will be the same as those during pretest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention will be provided for participants enrolled in the control group. |
| Rehearsal | Experimental | Behavioral: Rehearsal strategyParticipants will receive instruction on rehearsal strategy. |
| Reinforcement | Experimental | Behavioral: ReinforcementParticipants will receive reinforcement for correct recall. |
| Rehearsal + Reinforcement | Experimental | Behavioral: Rehearsal strategy and reinforcementThe participants in this group will receive instruction on rehearsal strategy and reinforcement for correct recall. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- have a diagnosis of autism
- have an echoic repertoire
Key exclusion criteria (1 listed)
- problem behavior or noncompliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehearsal strategyTeaching children to cumulatively rehearse numbers as they are being said. | Behavioural | Rehearsal |
| ReinforcementProviding reinforcement for correct recall after a delay. | Behavioural | Reinforcement |
| Rehearsal strategy and reinforcementTeaching children to cumulatively rehearse numbers as they are being said, AND providing reinforcement for correct recall after a delay. | Behavioural | Rehearsal + Reinforcement |
Primary outcome
Change in percent recall
Time frame: Before, during, and up to 2 weeks after intervention.
Participants will hear a sequence of digits or words (range from 1 to 9 stimuli) and then will be asked to recall the serial order after a delay (e.g., 9, 12, or 15 s). Percent correct recall of serial order will be calculated for all sequences as well as for each sequence size and delay. Change of percent recall from before, during, and after the intervention will be measured.
1 secondary outcome
Change in percent strategy used.
Time frame: During the intervention, and up to 2 weeks after intervention.
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Background: PubMed 31039192Habib A, Harris L, Pollick F, Melville C. A meta-analysis of working memory in individuals with autism spectrum disorders. PLoS One. 2019 Apr 30;14(4):e0216198. doi: 10.1371/journal.pone.0216198. eCollection 2019.
- Background: PubMed 15989932Joseph RM, Steele SD, Meyer E, Tager-Flusberg H. Self-ordered pointing in children with autism: failure to use verbal mediation in the service of working memory? Neuropsychologia. 2005;43(10):1400-11. doi: 10.1016/j.neuropsychologia.2005.01.010. Epub 2005 Feb 17.
- BackgroundBaltruschat L, Hasselhorn M, Tarbox J, Dixon D R, Najdowski AC, Mullins R D, Gould, ER. Addressing working memory in children with autism through behavioral intervention. Research in Autism Spectrum Disorders. 2011;5(1): 267-76. doi: 10.1016/j.rasd.2010.04.008
- BackgroundBebko JM, Rhee T, Ncube BL, Dahary H. Effectiveness and Retention of Teaching Memory Strategy Use to Children With Autism Spectrum Disorder. Canadian Journal of School Psychology. 2017;32(3-4): 244-64. doi: 10.1177/0829573517699332
- Individual participant dataSharing planned: No
Related trials for Autism
Recruiting
Effectiveness of Clown Therapy in Facilitating Dental Visits for Children With Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
RecruitingObservational study
Sensory Profile of People With High Intellectual Potential (HIP)
High Intellectual Potential
Recruiting
Cerebellar Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder: Raynor Cerebellum Project
Autism Spectrum Disorder
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Not yet recruiting
Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents
Sleep, Autism Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chengan Yuan, PhD principal investigator
Arizona State University
Erin Rotheram-Fuller, PhD principal investigator
Arizona State University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehearsal strategy, Reinforcement and Rehearsal strategy and reinforcement in people with Autism, run by Arizona State University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percent recall (time frame: Before, during, and up to 2 weeks after intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04209452, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.