Parent-implemented Intervention for Children With ASD: Effect on Social Communication and Brain Activation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change from baseline in the score of a semi-structured social imitation task
研究概览
简要总结
This randomised-controlled trial will assess the effect of an early intervention on the social-communicative abilities and brain activity of preschoolers with autism spectrum disorder (ASD). The children´s social-communicative abilities and the related brain activity will be evaluated at three time points: before the start of the intervention (pre-intervention), immediately after its conclusion (post-intervention) and several weeks after its conclusion (follow-up).
详细描述
Previous research has shown that parent-implemented interventions are effective in improving the social skills of children with autism spectrum disorder (ASD). The aim of the present project is to investigate the brain activity changes that are at the basis of the changes observed in the children's behaviour. More specifically, the investigators will assess the effect of Project ImPACT, a parent-implemented intervention, which teaches parents techniques to stimulate the social-communicative abilities of their children.
The intervention is suitable for preschoolers with a diagnosis of ASD and consists of 18 sessions of maximum 2 hours each, one session per week, delivered by trained therapists of the home guidance services in Flanders. Children with a diagnosis of ASD (or children who are suspected of ASD) between 1,5 and 4 years old and their parents will participate in the study. They will be randomly assigned to the ImPACT intervention or treatment as usual. The investigators will assess the effect of the intervention on the children's social-communicative abilities, and on the neural and biological correlates of these abilities.
The families will be invited to come to the Faculty of Psychology and Pedagogical Sciences at three time points: before the start of the intervention, immediately after the end of the intervention (which is expected to last 18 weeks) and 12 weeks after the end of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigators who are involved in the testing sessions and data analysis are blind to group assignment. An investigator which is not directly involved in participant testing or data analysis takes care of the randomisation, and coordinates it with the home guidance centers that administer the intervention.
入排标准
- 年龄范围
- 18 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical or working diagnosis of ASD
排除标准
- 未提供
研究组 & 干预措施
TAU
Treatment as usual (TAU) will be provided at the typical frequency, which is every 2-3 weeks. TAU can include targeting eating and sleeping problems, adaptive skills, or other goals. TAU will not include forms of intervention explicitly targeting social communicative skills. However, limited guidance on social communication development can be given if explicitly asked by parents.
干预措施: TAU (Other)
ImPACT
Project ImPACT will be provided in 18 weekly intervention sessions, during which parents will learn how to stimulate their children's social imitation, social engagement, language and play skills. First, parents are taught techniques that promote interaction with the child (one technique per session, through demonstration and coaching). In the second half of the intervention, parents are taught direct teaching techniques, e.g., to promote language or play, again by means of demonstration and coaching. After completion of the program, families will receive guidance every 2-3 weeks for an additional 12 weeks, during which the support will generally not focus on social-communicative abilities, although ImPACT follow-up sessions might be given if necessary.
干预措施: ImPACT (Other)
结局指标
主要结局
Change from baseline in the score of a semi-structured social imitation task
时间窗: outcome at 18 weeks from start of intervention (post-test)
Unpublished task developed by B. Ingersoll, author of the ImPACT intervention programme. Semi-structured observation of interaction with experimenter. Only the object scale is in use. The score ranges from 0 to 20, with higher scores corresponding to higher social imitation rates. Score increase is a positive outcome.
Change from baseline in the score of the Brief Observation of Social Communication Change (BOSCC)
时间窗: outcome at 18 weeks from start of intervention (post-test)
Semi-structured observation of interaction with parent and experimenter to assess social communication. The test contains 9 items that are meant to capture the quality of a child's social interaction, for which the total scores ranges from 0 to 45, and 3 items describing restricted a repetitive behaviour, which is also part of the ASD symptomatology, the total score of which ranges from 0 to 15. Three additional items are coded to add information on symptoms that might be present although they are not specifically part of the ASD syndrome, and refer to activity level, disruptive behaviour, and anxious behaviours. The BOSCC total score consists in the sum of the total score obtained in the first twelve items (ASD specific symptoms), and ranges from 0 to 60, with the three extra items added separately to integrate information. In the total and subscale scores, higher scores correspond to more severe symptoms. A decrease in the total score is thus considered a positive outcome.
Change from post-test in the score of the Brief Observation of Social Communication Change (BOSCC).
时间窗: follow-up at 12 weeks from end of intervention
Semi-structured observation of interaction with parent and experimenter to assess social communication. The test contains 9 items that are meant to capture the quality of a child's social interaction, for which the total scores ranges from 0 to 45, and 3 items describing restricted a repetitive behaviour, which is also part of the ASD symptomatology, the total score of which ranges from 0 to 15. Three additional items are coded to add information on symptoms that might be present although they are not specifically part of the ASD syndrome, and refer to activity level, disruptive behaviour, and anxious behaviours. The BOSCC total score consists in the sum of the total score obtained in the first twelve items (ASD specific symptoms), and ranges from 0 to 60, with the three extra items added separately to integrate information. In the total and subscale scores, higher scores correspond to more severe symptoms. Score stability (after decrease at outcome) or decrease is a positive outcome.
Change from post-test in electrophysiological event-related potentials in response to voice and non-voice sounds (N1, N2 and P3 effects), measured with EEG
时间窗: follow-up at 12 weeks from end of intervention
EEG activity recorded while children watch silent movies and passively listen to voice and non-voice sounds (passive oddball paradigm).
Change from post-test in haemodynamic response function (oxyhaemoglobin and deoxyhaemoglobin concentration in the cerebral cortex) evoked by social attention cues, measured with NIRS (near infrared spectroscopy)
时间窗: follow-up at 12 weeks from end of intervention
Oxy- and deoxyhaemoglobin concentration measured during a task in which an experimenter establishes social and non-social attention conditions while children watch fragments of age-appropriate cartoons.
Change from post-test in the score of the Early Social Communication Scales (ESCS)
时间窗: follow-up at 12 weeks from end of intervention
Structured observation of interaction with experimenter assessing joint attention. The measure includes continuous measurement of initiation of joint attention (IJA) and behavioural requests (IBR). The measurement of response to joint attention (RJA) is constrained by the numbered of joint attention bids offered by the administer, which is 14 in total. The IJA, IBR, and RJA subsections are considered separately, and the three scores are not combined. Stability (after increase at outcome) or increase in the IJA and RJA scores is interpreted as an improvement. A decrease in IBR, if combined with an increase of IJA, is generally also interpreted as a qualitative improvement of a child's social initiatives.
Change from baseline in the score of the Early Social Communication Scales (ESCS)
时间窗: outcome at 18 weeks from start of intervention (post-test)
Structured observation of interaction with experimenter assessing joint attention. The measure includes continuous measurement of initiation of joint attention (IJA) and behavioural requests (IBR). The measurement of response to joint attention (RJA) is constrained by the numbered of joint attention bids offered by the administer, which is 14 in total. The IJA, IBR, and RJA subsections are considered separately, and the three scores are not combined. An increase in the IJA and RJA scores is interpreted as an improvement. A decrease in IBR, if combined with an increase of IJA, is generally also interpreted as a qualitative improvement of a child's social initiatives.
Change from baseline in electrophysiological event-related potentials in response to voice and non-voice sounds (N1, N2 and P3 effects), measured with EEG
时间窗: outcome at 18 weeks from start of intervention (post-test)
EEG activity will be recorded while children watch silent movies and passively listen to voice and non-voice sounds (passive oddball paradigm).
Change from baseline in haemodynamic response function (oxyhaemoglobin and deoxyhaemoglobin concentration in the cerebral cortex) evoked by social attention cues, measured with NIRS (near infrared spectroscopy)
时间窗: outcome at 18 weeks from start of intervention (post-test)
Oxy- and deoxyhaemoglobin concentration measured during a task in which an experimenter establishes social and non-social attention conditions while children watch fragments of age-appropriate cartoons.
Change from post-test in the score of a semi-structured social imitation task
时间窗: follow-up at 12 weeks from end of intervention
Unpublished task developed by B. Ingersoll, author of the ImPACT intervention programme. Semi-structured observation of interaction with experimenter. Only the object scale is in use. The score ranges from 0 to 20, with higher scores corresponding to higher social imitation rates. Score stability (after increase at outcome) or increase is a positive outcome.
次要结局
- Change from baseline in the score of the Mullen Scales of Early Learning (M-SEL)(follow-up at 30 weeks from beginning of intervention)
- Change from baseline in the score of the Autism Diagnostic Observational Scale - 2 (ADOS-2)(follow-up at 30 weeks from beginning of intervention)
- Change from baseline in the score of the Vineland screener questionnaire (0-6 years).(outcome at 18 weeks from start of intervention (post-test))
- Change from baseline in the score of the Nijmeegse Ouderlijke Stress Index(outcome at 18 weeks from start of intervention (post-test))
- Change from post-test in the score of the Nijmeegse Ouderlijke Stress Index(follow-up at 12 weeks from end of intervention)
- Change from baseline in the score of the Dutch adaptation of the MacArthur Communicative Development Inventories (NCDI - short form)(outcome at 18 weeks from start of intervention (post-test))
- Change from post-test in the score of the Vineland screener questionnaire (0-6 years).(follow-up at 12 weeks from end of intervention)
- Change from post-test in the score of the Dutch adaptation of the MacArthur Communicative Development Inventories (NCDI - short form)(follow-up at 12 weeks from end of intervention)