Testing a Novel Parenting Intervention for Children With Autism
NCT ID: NCT04574206
Last Updated: 2021-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2020-12-01
2022-10-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
Elaborative Reminiscence (ER)
Parents will be trained to use elaborative communication techniques in conversations with their child.
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 .
Present Tense Talk (PTT)
Parents will be trained to engage their children in conversations, describing activities as they are actually happening.
Interventions
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Elaborative Reminiscence (ER)
Parents will be trained to use elaborative communication techniques in conversations with their child.
Present Tense Talk (PTT)
Parents will be trained to engage their children in conversations, describing activities as they are actually happening.
Eligibility Criteria
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Inclusion Criteria
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
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
7 Years
11 Years
ALL
No
Sponsors
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City, University of London
OTHER
Responsible Party
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Principal Investigators
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Anna Ramberg
Role: STUDY_DIRECTOR
City, University of London
Locations
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City University of London
London, Greater London, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GRY190053860
Identifier Type: -
Identifier Source: org_study_id
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