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Testing a Novel Parenting Intervention for Children With Autism (PAREint)

Primary Purpose

Autism Spectrum Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Elaborative Reminiscence (ER)
Present Tense Talk (PTT)
Sponsored by
City, University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorder

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

  • City University of LondonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Elaborative Reminiscence (ER)

Present Tense Talk (PTT)

Arm Description

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.

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 .

Outcomes

Primary Outcome Measures

Trial recruitment feasibility
The number of participants who dropped out of the trial as a percentage of the total number recruited.
Feasibility of training procedures
Percentage of participants who demonstrate 70% or more of intervention behaviours during the training roleplay assessment.
Training enactment
Change to caregiver reminiscing style ratio following training
Implementation fidelity (actual dosage)
The actual number of intervention behaviours caregivers demonstrate during conversations at post-trial.
Implementation fidelity (frequency of intervention delivery)
The mean number of intervention minutes delivered by caregivers
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.

Secondary Outcome Measures

Memory test
Change to child scores on the California Verbal Learning Test for Children (CVLT-C)
Memory elaborations
Number of child memory elaborations during parent-child conversations
Mental state understanding
Change to child scores on the Theory of Mind Battery
Self-concept
Change to child scores on the Self-Description Questionnaire

Full Information

First Posted
September 21, 2020
Last Updated
January 27, 2021
Sponsor
City, University of London
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1. Study Identification

Unique Protocol Identification Number
NCT04574206
Brief Title
Testing a Novel Parenting Intervention for Children With Autism
Acronym
PAREint
Official Title
Developing and Evaluating a Parent-child Intervention for Intellectually Able Children With Autism Spectrum Disorders: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City, University of London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
The study will be single-blinded at the participant level, however if further funding is obtained then the study will be double-blinded to include blinding at the researcher level.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Elaborative Reminiscence (ER)
Arm Type
Experimental
Arm Description
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.
Arm Title
Present Tense Talk (PTT)
Arm Type
Sham Comparator
Arm Description
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 .
Intervention Type
Behavioral
Intervention Name(s)
Elaborative Reminiscence (ER)
Intervention Description
Parents will be trained to use elaborative communication techniques in conversations with their child.
Intervention Type
Behavioral
Intervention Name(s)
Present Tense Talk (PTT)
Intervention Description
Parents will be trained to engage their children in conversations, describing activities as they are actually happening.
Primary Outcome Measure Information:
Title
Trial recruitment feasibility
Description
The number of participants who dropped out of the trial as a percentage of the total number recruited.
Time Frame
20 weeks post-trial
Title
Feasibility of training procedures
Description
Percentage of participants who demonstrate 70% or more of intervention behaviours during the training roleplay assessment.
Time Frame
Baseline
Title
Training enactment
Description
Change to caregiver reminiscing style ratio following training
Time Frame
Change from baseline to 20 weeks post-trial
Title
Implementation fidelity (actual dosage)
Description
The actual number of intervention behaviours caregivers demonstrate during conversations at post-trial.
Time Frame
20 weeks post-trial
Title
Implementation fidelity (frequency of intervention delivery)
Description
The mean number of intervention minutes delivered by caregivers
Time Frame
20 weeks post-trial
Title
Intervention acceptability
Description
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 Outcome Measure Information:
Title
Memory test
Description
Change to child scores on the California Verbal Learning Test for Children (CVLT-C)
Time Frame
Change from baseline to 20 weeks post-trial
Title
Memory elaborations
Description
Number of child memory elaborations during parent-child conversations
Time Frame
Change from baseline to 20 weeks post-trial
Title
Mental state understanding
Description
Change to child scores on the Theory of Mind Battery
Time Frame
Change from baseline to 20 weeks post-trial
Title
Self-concept
Description
Change to child scores on the Self-Description Questionnaire
Time Frame
Change from baseline to 20 weeks post-trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gemma Ryan, MSc
Phone
(+44) 07340109163
Email
gemma.ryan@city.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Cartwright, PhD
Phone
(+44) 02070400879
Email
martin.cartwright.1@city.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Ramberg
Organizational Affiliation
City, University of London
Official's Role
Study Director
Facility Information:
Facility Name
City University of London
City
London
State/Province
Greater London
ZIP/Postal Code
EC1V 0HB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gemma Ryan, MSc
Phone
(+44) 07340109163
Email
gemma.ryan@city.ac.uk
First Name & Middle Initial & Last Name & Degree
Martin Cartwright, PhD
Phone
(+44) 02070400879
Email
martin.cartwright.1@city.ac.uk

12. IPD Sharing Statement

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

Learn more about this trial

Testing a Novel Parenting Intervention for Children With Autism

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