Testing a Novel Parenting Intervention for Children With Autism

Autism Spectrum Disorder Clinical Trial

— PAREint  

Official title:

Developing and Evaluating a Parent-child Intervention for Intellectually Able Children With Autism Spectrum Disorders: A Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04574206
• Other study ID #: GRY190053860
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: October 2022

Study information

• Verified date: September 2020
• Source: City, University of London
• Contact: Gemma Ryan, MSc
• Phone: (+44) 07340109163
• Email: gemma.ryan[@]city.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United Kingdom	City University of London	London	Greater London

Sponsors (1)

Lead Sponsor	Collaborator
City, University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trial recruitment feasibility	The number of participants who dropped out of the trial as a percentage of the total number recruited.	20 weeks post-trial
Primary	Feasibility of training procedures	Percentage of participants who demonstrate 70% or more of intervention behaviours during the training roleplay assessment.	Baseline
Primary	Training enactment	Change to caregiver reminiscing style ratio following training	Change from baseline to 20 weeks post-trial
Primary	Implementation fidelity (actual dosage)	The actual number of intervention behaviours caregivers demonstrate during conversations at post-trial.	20 weeks post-trial
Primary	Implementation fidelity (frequency of intervention delivery)	The mean number of intervention minutes delivered by caregivers	20 weeks post-trial
Primary	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.	20 weeks post-trial
Secondary	Memory test	Change to child scores on the California Verbal Learning Test for Children (CVLT-C)	Change from baseline to 20 weeks post-trial
Secondary	Memory elaborations	Number of child memory elaborations during parent-child conversations	Change from baseline to 20 weeks post-trial
Secondary	Mental state understanding	Change to child scores on the Theory of Mind Battery	Change from baseline to 20 weeks post-trial
Secondary	Self-concept	Change to child scores on the Self-Description Questionnaire	Change from baseline to 20 weeks post-trial