Testing a Novel Parenting Intervention for Children With Autism

NCT04574206 | Unknown

• 1 other identifier: GRY190053860
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (6)

• 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

• Feasibility of training procedures

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

  Baseline

• Training enactment

  Change to caregiver reminiscing style ratio following training

  Change from baseline to 20 weeks post-trial

• Implementation fidelity (actual dosage)

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

  20 weeks post-trial

• Implementation fidelity (frequency of intervention delivery)

  The mean number of intervention minutes delivered by caregivers

  20 weeks post-trial

• 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 Outcomes (4)

• Memory test

  Change from baseline to 20 weeks post-trial

• Memory elaborations

  Change from baseline to 20 weeks post-trial

• Mental state understanding

  Change from baseline to 20 weeks post-trial

• Self-concept

  Change from baseline to 20 weeks post-trial

Study Arms (2)

Elaborative Reminiscence (ER)

EXPERIMENTAL

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)

Present Tense Talk (PTT)

SHAM COMPARATOR

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

Elaborative Reminiscence (ER) BEHAVIORAL

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

Elaborative Reminiscence (ER)

Present Tense Talk (PTT) BEHAVIORAL

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

Present Tense Talk (PTT)

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Caregivers and children:
• \) 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

Sponsors & Collaborators

• City, University of London: lead

Study Sites (1)

City University of London

London, Greater London, EC1V 0HB, United Kingdom

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Anna Ramberg

  City, University of London

  STUDY DIRECTOR

Central Study Contacts

Gemma Ryan, MSc

CONTACT

(+44) 07340109163; gemma.ryan@city.ac.uk

Martin Cartwright, PhD

CONTACT

(+44) 02070400879; martin.cartwright.1@city.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 5, 2020
• Study Start: December 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: October 1, 2022
• Last Updated: January 28, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)