Autism Spectrum DisorderPAREintNCT04574206
Testing a Novel Parenting Intervention for Children With Autism
A study testing Elaborative Reminiscence (ER) and Present Tense Talk (PTT) in people with Autism Spectrum Disorder, run by City, University of London at 1 site in United Kingdom.
Trial summary
This study will investigate the acceptability and preliminary effectiveness of training parents to use a structured communication intervention that is aimed towards helping children with autism spectrum disorder (ASD). Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Elaborative Reminiscence (ER) and Present Tense Talk (PTT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2020to Oct 2022
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Caregivers and children:
- Must have access to a digital device capable of receiving video calls (e.g. smartphone, tablet or computer) and internet
- Must primarily speak in English, as assessed with a pre-screening survey question.
- Children only:
- Aged 7-11 years
- Diagnostic status i) Documented clinical diagnosis of ASD provided by caregivers or schools (e.g. a diagnostic report), OR ii) Meeting cut off for autism on the Social Communication Questionnaire (i.e. Score above or equal to 15 on SCQ)
- Intelligence within the average range or above as measured by the Raven's Coloured Progressive Matrices (ie minimum IQ within 2 SD below the mean).
- Developmental and linguistic levels within the average range as measured by the Vineland Adaptive Behaviour Scales (VABS-3) and the British Picture Vocabulary Scale (BPVS).
Who cannot join
- Caregivers and children:
- 3) Must not currently be receiving care or treatment for a mental or psychiatric condition 4) Must not be currently taking part in another research study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
City University of London
London, Greater London, EC1V 0HB
Gemma Ryan, MSc, (+44) 07340109163, gemma.ryan@city.ac.uk
Martin Cartwright, PhD, (+44) 02070400879, martin.cartwright.1@city.ac.uk
About this study
Official title: Developing and Evaluating a Parent-child Intervention for Intellectually Able Children With Autism Spectrum Disorders: A Feasibility Study
This study will investigate the acceptability and preliminary effectiveness of training parents to use a structured communication intervention that is aimed towards helping children with autism spectrum disorder (ASD).
This intervention has demonstrated benefits for non-autistic children in known areas of difficulty found with autistic individuals. There are currently few evidence-based interventions for school-aged children with ASD who have no other language or intellectual disabilities and are educated in mainstream schools. We will evaluate the benefits of training parents to use a freely available communication technique designed to tackle underlying psychological processes crucial to later development.
Read the detailed description
Over recent years a growing body of research has reported significant, beneficial effects of using an "elaborative reminiscence" (ER) intervention on a range of typically-developing child outcomes including memory language skills, emotional understanding and understanding of mind. A recently published 9- year follow-up study further indicates that these benefits are longstanding. This has prompted speculation that ER could be a beneficial intervention for children with neurodevelopmental disorders who have known difficulties in these areas. To date, no studies have assessed the benefits of using ER as an intervention for ASD.
This study aims to evaluate the feasibility, acceptability and preliminary effectiveness of training parents to use ER as an intervention for high-functioning children with ASD. This study will use a two-arm, parallel-group, randomised controlled design to compare a parent-delivered ER intervention against a control intervention (present tense talk).
Fifty parent-child dyads (comprising children with ASD and IQ >70) will be recruited from mainstream schools, specialist unit/ schools, or relevant organisations (25 dyads per trial arm). Primary outcomes will be NIHR-recognised quantitative indicators of feasibility and acceptability for the ER condition.This will include (yet is not limited to) exploring the feasibility of methods of recruiting participants, feasibility of administering outcome assessments at baseline and follow-up, feasibility of delivering the training for ER and PTT remotely (i.e. through video conferencing), the feasibility of parents delivering ER or PTT in their home setting, and the acceptability of ER to parents. Parent acceptability of ER will be assessed using a daily logbook questionnaire and post-trial interviews, based on the Theoretical Framework of Acceptability.
Secondary outcomes will be measures of clinical and functional outcomes for both experimental conditions. Descriptive measures of general intelligence, vocabulary and developmental level will be administered at baseline for both experimental conditions (ER and PTT) and used to describe the participant sample. Outcome measures for child memory, mental state understanding, and self-concept will be administered at baseline and again after 20 weeks to assess change or response to the interventions. Differences in parent reminiscing style from baseline to post-trial will be assessed for all participants to assess the success of intervention training.
On completion of follow-up outcome assessments, parents in the ER condition will be invited to participate in a single qualitative interview to evaluate the acceptability of the ER intervention and study procedures. Interviews will be based on the Theoretical Framework of Acceptability and the Necessity-Concerns Framework.
Descriptive statistics will be taken for indicators of intervention feasibility and acceptability.Comparisons between the two trial arms will be made using inferential statistical analysis for multiple outcomes, whilst adjusting for covariates.
In response to the present Covid-19 situation, this study will take place remotely. All interaction with participants (recruitment and data collection and participant testing) will use video software (e.g. Zoom, AdobeConnect, MS Teams), or online surveys (e.g. Qualtrics). Data analysis will either take place in the Autism Research Unit laboratory, located at City University of London, or remotely via a secure network.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Elaborative Reminiscence (ER), Present Tense Talk (PTT)
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elaborative Reminiscence (ER)Behavioural
Parents will be trained to use elaborative communication techniques in conversations with their child.
Present Tense Talk (PTT)Behavioural
Parents will be trained to engage their children in conversations, describing activities as they are actually happening.
| Study group | Role | What they receive |
|---|---|---|
| Elaborative Reminiscence (ER) | Experimental | ER is a communication strategy used between a caregiver and child to support children's cognitive and emotional development. ER involves a caregiver and child jointly reminiscing about a past event that they personally experienced, to co-create a coherent narrative that describes the event from both their perspectives. ER consists of two crucial elements, the use of elaborative language (e.g. open ended questions, contributing new information to the conversation) and specific talk focused on recollections of the past as opposed to observations of the present. Receives: Behavioral: Elaborative Reminiscence (ER) |
| Present Tense Talk (PTT) | Sham comparator | PTT is an active control intervention, designed to ensure that caregivers/ guardians in this group spend a similar amount of time engaging in conversation with their children but do not use elaborative reminiscing language. The focus will be on describing activities as they are happening in real time; PTT caregivers will be asked to avoid reference future or past events . Receives: Behavioral: Present Tense Talk (PTT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial recruitment feasibility
The number of participants who dropped out of the trial as a percentage of the total number recruited.
Measured: 20 weeks post-trial
Feasibility of training procedures
Percentage of participants who demonstrate 70% or more of intervention behaviours during the training roleplay assessment.
Measured: Baseline
Training enactment
Change to caregiver reminiscing style ratio following training
Measured: Change from baseline to 20 weeks post-trial
Implementation fidelity (actual dosage)
The actual number of intervention behaviours caregivers demonstrate during conversations at post-trial.
Measured: 20 weeks post-trial
Implementation fidelity (frequency of intervention delivery)
The mean number of intervention minutes delivered by caregivers
Measured: 20 weeks post-trial
Intervention acceptability
A qualitative analysis (guided by the Theoretical Framework of Acceptability) of post-trial caregiver interviews to determine caregiver acceptability of the ER intervention.
Measured: 20 weeks post-trial
Secondary outcomes (4)
Memory test
Change to child scores on the California Verbal Learning Test for Children (CVLT-C)
Measured: Change from baseline to 20 weeks post-trial
Memory elaborations
Number of child memory elaborations during parent-child conversations
Measured: Change from baseline to 20 weeks post-trial
Mental state understanding
Change to child scores on the Theory of Mind Battery
Measured: Change from baseline to 20 weeks post-trial
Self-concept
Change to child scores on the Self-Description Questionnaire
Measured: Change from baseline to 20 weeks post-trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Dec 2020
- Primary completionAug 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, randomised pilot study to compare a caregiver-delivered elaborative reminiscence intervention against a control intervention for children with autism spectrum disorder, aged 7-11 years. Randomisation will occur at the participant level and participants will be allocated to the trial arms using a 1:1 ratio.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Ramberg, Study director, City, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574206
- Sponsor's protocol ID
- GRY190053860
- Acronym
- PAREint
- Status last verified
- Sep 2020
- First submitted
- 21 Sep 2020
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As this is a PhD research study, no plan nor ethical approval has yet been obtained to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Evaluating a Parent-child Intervention for Intellectually Able Children With Autism Spectrum Disorders: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04574206
- Acronym / sponsor ID
- PAREint / GRY190053860
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- City, University of LondonUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 5 Oct 2020 (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.
This study will investigate the acceptability and preliminary effectiveness of training parents to use a structured communication intervention that is aimed towards helping children with autism spectrum disorder (ASD).
This intervention has demonstrated benefits for non-autistic children in known areas of difficulty found with autistic individuals. There are currently few evidence-based interventions for school-aged children with ASD who have no other language or intellectual disabilities and are educated in mainstream schools. We will evaluate the benefits of training parents to use a freely available communication technique designed to tackle underlying psychological processes crucial to later development.
Detailed description
Over recent years a growing body of research has reported significant, beneficial effects of using an "elaborative reminiscence" (ER) intervention on a range of typically-developing child outcomes including memory language skills, emotional understanding and understanding of mind. A recently published 9- year follow-up study further indicates that these benefits are longstanding. This has prompted speculation that ER could be a beneficial intervention for children with neurodevelopmental disorders who have known difficulties in these areas. To date, no studies have assessed the benefits of using ER as an intervention for ASD.
This study aims to evaluate the feasibility, acceptability and preliminary effectiveness of training parents to use ER as an intervention for high-functioning children with ASD. This study will use a two-arm, parallel-group, randomised controlled design to compare a parent-delivered ER intervention against a control intervention (present tense talk).
Fifty parent-child dyads (comprising children with ASD and IQ >70) will be recruited from mainstream schools, specialist unit/ schools, or relevant organisations (25 dyads per trial arm). Primary outcomes will be NIHR-recognised quantitative indicators of feasibility and acceptability for the ER condition.This will include (yet is not limited to) exploring the feasibility of methods of recruiting participants, feasibility of administering outcome assessments at baseline and follow-up, feasibility of delivering the training for ER and PTT remotely (i.e. through video conferencing), the feasibility of parents delivering ER or PTT in their home setting, and the acceptability of ER to parents. Parent acceptability of ER will be assessed using a daily logbook questionnaire and post-trial interviews, based on the Theoretical Framework of Acceptability.
Secondary outcomes will be measures of clinical and functional outcomes for both experimental conditions. Descriptive measures of general intelligence, vocabulary and developmental level will be administered at baseline for both experimental conditions (ER and PTT) and used to describe the participant sample. Outcome measures for child memory, mental state understanding, and self-concept will be administered at baseline and again after 20 weeks to assess change or response to the interventions. Differences in parent reminiscing style from baseline to post-trial will be assessed for all participants to assess the success of intervention training.
On completion of follow-up outcome assessments, parents in the ER condition will be invited to participate in a single qualitative interview to evaluate the acceptability of the ER intervention and study procedures. Interviews will be based on the Theoretical Framework of Acceptability and the Necessity-Concerns Framework.
Descriptive statistics will be taken for indicators of intervention feasibility and acceptability.Comparisons between the two trial arms will be made using inferential statistical analysis for multiple outcomes, whilst adjusting for covariates.
In response to the present Covid-19 situation, this study will take place remotely. All interaction with participants (recruitment and data collection and participant testing) will use video software (e.g. Zoom, AdobeConnect, MS Teams), or online surveys (e.g. Qualtrics). Data analysis will either take place in the Autism Research Unit laboratory, located at City University of London, or remotely via a secure network.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a two-arm, randomised pilot study to compare a caregiver-delivered elaborative reminiscence intervention against a control intervention for children with autism spectrum disorder, aged 7-11 years. Randomisation will occur at the participant level and participants will be allocated to the trial arms using a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Elaborative Reminiscence (ER) | Experimental | Behavioral: Elaborative Reminiscence (ER)ER is a communication strategy used between a caregiver and child to support children's cognitive and emotional development. ER involves a caregiver and child jointly reminiscing about a past event that they personally experienced, to co-create a coherent narrative that describes the event from both their perspectives. ER consists of two crucial elements, the use of elaborative language (e.g. open ended questions, contributing new information to the conversation) and specific talk focused on recollections of the past as opposed to observations of the present. |
| Present Tense Talk (PTT) | Sham comparator | Behavioral: Present Tense Talk (PTT)PTT is an active control intervention, designed to ensure that caregivers/ guardians in this group spend a similar amount of time engaging in conversation with their children but do not use elaborative reminiscing language. The focus will be on describing activities as they are happening in real time; PTT caregivers will be asked to avoid reference future or past events . |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Must have access to a digital device capable of receiving video calls (e.g. smartphone, tablet or computer) and internet
- Must primarily speak in English, as assessed with a pre-screening survey question.
- Aged 7-11 years
- Diagnostic status i) Documented clinical diagnosis of ASD provided by caregivers or schools (e.g. a diagnostic report), OR ii) Meeting cut off for autism on the Social Communication Questionnaire (i.e. Score above or equal to 15 on SCQ)
- Intelligence within the average range or above as measured by the Raven's Coloured Progressive Matrices (ie minimum IQ within 2 SD below the mean).
Key exclusion criteria (2 listed)
- 3) Must not currently be receiving care or treatment for a mental or psychiatric condition 4) Must not be currently taking part in another research study
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 |
|---|---|---|
| Elaborative Reminiscence (ER)Parents will be trained to use elaborative communication techniques in conversations with their child. | Behavioural | Elaborative Reminiscence (ER) |
| Present Tense Talk (PTT)Parents will be trained to engage their children in conversations, describing activities as they are actually happening. | Behavioural | Present Tense Talk (PTT) |
Primary outcome
Trial recruitment feasibility
Time frame: 20 weeks post-trial
The number of participants who dropped out of the trial as a percentage of the total number recruited.
Feasibility of training procedures
Time frame: Baseline
Percentage of participants who demonstrate 70% or more of intervention behaviours during the training roleplay assessment.
Training enactment
Time frame: Change from baseline to 20 weeks post-trial
Change to caregiver reminiscing style ratio following training
Implementation fidelity (actual dosage)
Time frame: 20 weeks post-trial
The actual number of intervention behaviours caregivers demonstrate during conversations at post-trial.
Implementation fidelity (frequency of intervention delivery)
Time frame: 20 weeks post-trial
The mean number of intervention minutes delivered by caregivers
Intervention acceptability
Time frame: 20 weeks post-trial
A qualitative analysis (guided by the Theoretical Framework of Acceptability) of post-trial caregiver interviews to determine caregiver acceptability of the ER intervention.
4 secondary outcomes
Memory test
Time frame: Change from baseline to 20 weeks post-trial
Memory elaborations
Time frame: Change from baseline to 20 weeks post-trial
Mental state understanding
Time frame: Change from baseline to 20 weeks post-trial
Self-concept
Time frame: Change from baseline to 20 weeks post-trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: No. As this is a PhD research study, no plan nor ethical approval has yet been obtained to make IPD available to other researchers.
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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.
Anna Ramberg study director
City, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elaborative Reminiscence (ER) and Present Tense Talk (PTT) in people with Autism Spectrum Disorder, run by City, University of London at 1 site in United Kingdom.
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 8 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gemma Ryan, MSc ((+44) 07340109163, gemma.ryan@city.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trial recruitment feasibility (time frame: 20 weeks post-trial). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2021.