Clinical trial NCT04574206: Testing a Novel Parenting Intervention for Children With Autism
Official title: Developing and Evaluating a Parent-child Intervention for Intellectually Able Children With Autism Spectrum Disorders: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: City, University of London
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Trial recruitment feasibility
timeFrame: 20 weeks post-trial
measure: Feasibility of training procedures
timeFrame: Baseline
measure: Training enactment
timeFrame: Change from baseline to 20 weeks post-trial
measure: Implementation fidelity (actual dosage)
timeFrame: 20 weeks post-trial
measure: Implementation fidelity (frequency of intervention delivery)
timeFrame: 20 weeks post-trial
measure: Intervention acceptability
timeFrame: 20 weeks post-trial
Secondary outcomes:
measure: Memory test
timeFrame: Change from baseline to 20 weeks post-trial
measure: Memory elaborations
timeFrame: Change from baseline to 20 weeks post-trial
measure: Mental state understanding
timeFrame: Change from baseline to 20 weeks post-trial
measure: Self-concept
timeFrame: Change from baseline to 20 weeks post-trial
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: City University of London
state: Greater London
Study officials:
affiliation: City, University of London
name: Anna Ramberg
role: STUDY_DIRECTOR
References: