ClinicalTrials.gg
Status unknownNCT04574206PAREintUpdated Jan 28, 2021

Testing a Novel Parenting Intervention for Children With Autism

An interventional study of Elaborative Reminiscence (ER) and Present Tense Talk (PTT) in Autism Spectrum Disorder, sponsored by City, University of London. Status unknown at 1 site in United Kingdom. Open to participants aged 7 Years to 11 Years. Per ClinicalTrials.gov, last updated 2021-01-28.

Sponsored by City, University of London · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
7 Years to 11 Years
Sex
All
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Study 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).

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.

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Conditions studied

  • Autism Spectrum Disorder
03

In context

Autism Spectrum Disorder

1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.

This study's planned enrollment of 50 is close to the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

City, University of London is the lead sponsor of 25 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Caregivers and children:

  1. Must have access to a digital device capable of receiving video calls (e.g. smartphone, tablet or computer) and internet
  2. Must primarily speak in English, as assessed with a pre-screening survey question.

Children only:

  1. Aged 7-11 years
  2. 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)
  3. 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).
  4. 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).

Exclusion criteria

Exclusion Criteria:

Caregivers and children:

  1. 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Elaborative Reminiscence (ER)

  • Sham comparator
    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 .

    Behavioral: Present Tense Talk (PTT)

Interventions

  • BehavioralElaborative Reminiscence (ER)

    Parents will be trained to use elaborative communication techniques in conversations with their child.

  • BehavioralPresent Tense Talk (PTT)

    Parents will be trained to engage their children in conversations, describing activities as they are actually happening.

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What researchers measure

Primary outcomes

  1. Trial recruitment feasibility

    The number of participants who dropped out of the trial as a percentage of the total number recruited.

    Time frame: 20 weeks post-trial

  2. Feasibility of training procedures

    Percentage of participants who demonstrate 70% or more of intervention behaviours during the training roleplay assessment.

    Time frame: Baseline

  3. Training enactment

    Change to caregiver reminiscing style ratio following training

    Time frame: Change from baseline to 20 weeks post-trial

  4. Implementation fidelity (actual dosage)

    The actual number of intervention behaviours caregivers demonstrate during conversations at post-trial.

    Time frame: 20 weeks post-trial

  5. Implementation fidelity (frequency of intervention delivery)

    The mean number of intervention minutes delivered by caregivers

    Time frame: 20 weeks post-trial

  6. 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.

    Time frame: 20 weeks post-trial

Secondary outcomes

  1. Memory test

    Change to child scores on the California Verbal Learning Test for Children (CVLT-C)

    Time frame: Change from baseline to 20 weeks post-trial

  2. Memory elaborations

    Number of child memory elaborations during parent-child conversations

    Time frame: Change from baseline to 20 weeks post-trial

  3. Mental state understanding

    Change to child scores on the Theory of Mind Battery

    Time frame: Change from baseline to 20 weeks post-trial

  4. Self-concept

    Change to child scores on the Self-Description Questionnaire

    Time frame: Change from baseline to 20 weeks post-trial

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No — As this is a PhD research study, no plan nor ethical approval has yet been obtained to make IPD available to other researchers.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2020 (actual). Primary completion is estimated for Aug 2022, 20 months after the start.

Of 800 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 20 months is below that.

Counting every sponsor, half of 823 studies reached it within 25 months; a quarter within 12 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2020
First posted
Oct 5, 2020
StartActual
Dec 1, 2020
Primary completionEst.
Aug 2022
CompletionEst.
Oct 2022
Last update
Jan 28, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04574206
Lead sponsor
City, University of London
Responsible party
Sponsor
First posted
Oct 5, 2020
Start date
Dec 1, 2020
Primary completion
Aug 2022 (estimated)
Completion
Oct 2022 (estimated)
Last update
Jan 28, 2021

Study contacts

Gemma Ryan, MSc
Contact
gemma.ryan@city.ac.uk
(+44) 07340109163
Martin Cartwright, PhD
Contact
martin.cartwright.1@city.ac.uk
(+44) 02070400879
Anna Ramberg
study director · City, University of London

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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