跳至主要内容
临床试验/NCT04097457
NCT04097457Unknown不适用

A Community-implemented, Parent-mediated, Group Intervention for Children With Autism Spectrum Disorder (ASD) and Disruptive Behaviors.

Hebrew University of Jerusalem1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年10月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Home Situations Questionnaire (HSQ) (Barkley & Murphy, 1998)

研究概览

简要总结

The goal of the study is to providing parents of children diagnosed with autism spectrum disorders (ASD) and disruptive behaviors essential skills to manage their children's behaviors using an evidence based parent training protocol. Beyond the feasibility of delivering an evidence based intervention in groups and with community partners, primary and secondary outcomes in both the children and the parents who participated in the study are assessed during and after the intervention process

详细描述

the investigators will deliver parent-mediated, community-implemented, group intervention for parents of young children with autism and disruptive behavior. The intervention is 11-12 weeks and will take place in community settings such as special education schools and community centers.

Within these meetings parents will be given the skills to understand their child's behavior and work to modify those that are clinically disruptive to the child and their environment.

Groups will be facilitated by student therapists under direct weekly supervision of a Board Certified Behavior Analyst (BCBA). Data will be collected before, after, and throughout the intervention, primarily by parent-report with one teacher-report measure and two (pre/post) filmed parent-child interactions.

The primary desired outcome is a measurable decrease in the child's disruptive behaviors and an increase in their adaptive behaviors. Although the intervention specifically targets disruptive behavior, we expect to see consequent improvement in a number of linked domains. These represent desired secondary outcomes.

First, as a result of receiving concrete skills and seeing improvement in their child's behavior, as well as due to participation in the group with other families, a reduction in parental stress and an increase in their perceived self-efficacy should occur, as well as a reduction in the stress of the non-participating parent.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Formal ASD diagnosis

排除标准

  • 未提供

研究组 & 干预措施

Parent mediated intervention (PMI) group

Experimental

A short term parent training protocol based on behavioral principles, which is delivered by trained therapists. The protocol includes eleven core sessions, a home visit session, follow-up telephone booster sessions and seven supplemental sessions, designed to be delivered to parents in an outpatient and home settings. The protocol is administered to groups of 4 families.

干预措施: "Parent training for disruptive behaviors" manual (Bearss, Johnson, Handen, Butter, Lecavalier, Smith & Scahill, 2018) (Behavioral)

Waitlist control

Experimental

Families will be recruited and will fill out measure for 3 months prior to participation and will then join the active intervention

干预措施: "Parent training for disruptive behaviors" manual (Bearss, Johnson, Handen, Butter, Lecavalier, Smith & Scahill, 2018) (Behavioral)

Individual

Experimental

A short term parent training protocol based on behavioral principles, which is delivered by trained therapists. The protocol includes eleven core sessions, a home visit session, follow-up telephone booster sessions and seven supplemental sessions, designed to be delivered to parents in an outpatient and home settings. In this arm the protocol is administered individually to families.

干预措施: "Parent training for disruptive behaviors" manual (Bearss, Johnson, Handen, Butter, Lecavalier, Smith & Scahill, 2018) (Behavioral)

结局指标

主要结局

Home Situations Questionnaire (HSQ) (Barkley & Murphy, 1998)

时间窗: Administered to parents at baseline, 12 weeks and at 20 weeks.The measure will be administered at different time points in order to follow changes in compliance levels of the participants.

A caregiver-rated scale for child noncompliance across 24 everyday situations. Each item is rated as a problem: ''yes'' or ''no''; ''yes'' items are then scored from 1 (mild) to 9 (severe), on two subscales: 'Demand-Specific' and 'Socially Inflexible' (Chowdhury et al. 2010). The total severity score is divided by 24 to obtain a per item mean.

The aberrant behavior checklist: a behavior rating scale for the assessment of treatment effects (Aman, M. G., Singh, N. N., Stewart, A. W., & Field, C. J.,1985)

时间窗: Administered to parents and teachers at baseline, 4 weeks, 8 weeks, 12 weeks (end-point), 16 weeks and 20 weeks (follow-up). The measure will be administered at different time points to follow changes in severe disruptive behaviors of the participants

A caregiver and teacher report measure of disruptive behaviors including 58 items, each rated on a four-point Likert scale (0-3), with higher scores indicative of more severe problem behavior. Includes five subscales: Irritability (tantrums, aggression and self-injury, 15 items); Social Withdrawal (16 items); Stereotypic Behavior (7 items); Hyperactivity (16 items); and Inappropriate Speech (4 items). In children with ASD, the ABC subscales demonstrate adequate internal consistencies (α=.77-.94) and convergent validity (Kaat, Lecavalier, \& Aman, 2014). The measure will be administered at different time points on order to follow changes in the disruptive behaviors of the participants.

Social Responsiveness Scale (SRS) (Constantino & Gruber, 2005)

时间窗: Administered to parents at baseline, 12 weeks and at 20 weeks. The measure will be administered at different time points in order to follow changes in social-related behaviors of the participants.

A caregiver - and teacher-report measure of child social competence with 65 items, each rated on a four-point Likert scale (1-4), with higher scores indicative of more problematic social-related behaviors, in the domains of social awareness, social cognition, social communication, social motivation, and autistic mannerisms (e.g., restricted or repetitive behaviors). All subscales have acceptable internal consistency (α = .77-.92) and test-retest reliability (Constantino et al., 2003)

Adaptive Behavior Assessment System (ABAS-II)

时间窗: administered to participating parents at baseline, 12 weeks and at 20 weeks. The measure will be administered at different time points in order to follow changes related to adaptive behaviors of the participants.

A comprehensive evaluation tool, covering the ten adaptive behavior deficit areas defined by the DSM-5 (APA, 2013), and it is recommended for use as part of the standard ASD diagnostic evaluation process, by the Ministry of Health in Israel. The ABAS-II provides standard scores on the following core domains: Communication; Use of Community Resources; Academic Functional Skills; Daily Living Skills; Health and Security; Leisure; Self-Help; Self-Direction; Socialization and Occupation, as well as a General Adaptive Behavior Composite Score (GAC). Items are rated on a four-point Likert scale (0-3), with higher scores indicative of higher adaptive functioning.

次要结局

  • Parenting Stress Index Short Version (PSI-SR) (Abidin, 1990)(administered to all participating and non-participating parents at baseline, 12 weeks and at 20 weeks.The measure will be administered at different time points in order to follow changes in stress levels of parent participants.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eyal Cohen

Study coordinator

Hebrew University of Jerusalem

研究点 (1)

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