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临床试验/NCT04574206
NCT04574206Unknown不适用

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

City, University of London2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Feasibility of training procedures

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
7 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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

结局指标

主要结局

Feasibility of training procedures

时间窗: Baseline

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

Training enactment

时间窗: Change from baseline to 20 weeks post-trial

Change to caregiver reminiscing style ratio following training

Intervention acceptability

时间窗: 20 weeks post-trial

A qualitative analysis (guided by the Theoretical Framework of Acceptability) of post-trial caregiver interviews to determine caregiver acceptability of the ER intervention.

Implementation fidelity (actual dosage)

时间窗: 20 weeks post-trial

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

Trial recruitment feasibility

时间窗: 20 weeks post-trial

The number of participants who dropped out of the trial as a percentage of the total number recruited.

Implementation fidelity (frequency of intervention delivery)

时间窗: 20 weeks post-trial

The mean number of intervention minutes delivered by caregivers

次要结局

  • Mental state understanding(Change from baseline to 20 weeks post-trial)
  • Self-concept(Change from baseline to 20 weeks post-trial)
  • Memory test(Change from baseline to 20 weeks post-trial)
  • Memory elaborations(Change from baseline to 20 weeks post-trial)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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