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Group Based Parent Training for Children With Autism and Disruptive Behaviors

Primary Purpose

Autism Spectrum Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
"Parent training for disruptive behaviors" manual (Bearss, Johnson, Handen, Butter, Lecavalier, Smith & Scahill, 2018)
Sponsored by
Hebrew University of Jerusalem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

4 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Formal ASD diagnosis

Exclusion Criteria:

-

Sites / Locations

  • The Hebrew universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Parent mediated intervention (PMI) group

Waitlist control

Individual

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

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)
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.
Home Situations Questionnaire (HSQ) (Barkley & Murphy, 1998)
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.
Social Responsiveness Scale (SRS) (Constantino & Gruber, 2005)
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)
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.

Secondary Outcome Measures

Parenting Stress Index Short Version (PSI-SR) (Abidin, 1990)
A self-report inventory designed to measure the overall level of parenting stress an individual is experiencing and it examine stressors associated specifically with the parental role and do not include stresses associated with other life roles and events. The PSI-SR has strong psychometric properties and has been used in a number of studies of autism and parent training, and was also found valid and reliable when tested on Israeli parents (sharf 1989; Turkel 2002). It contains 36 items, each rated on a five-point Likert scale (1-5), with higher scores indicative of more parenting stress and includes Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI) and Difficult Child (DC) sub-scales.

Full Information

First Posted
September 16, 2019
Last Updated
September 18, 2019
Sponsor
Hebrew University of Jerusalem
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1. Study Identification

Unique Protocol Identification Number
NCT04097457
Brief Title
Group Based Parent Training for Children With Autism and Disruptive Behaviors
Official Title
A Community-implemented, Parent-mediated, Group Intervention for Children With Autism Spectrum Disorder (ASD) and Disruptive Behaviors.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
September 2, 2020 (Anticipated)
Study Completion Date
January 2, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebrew University of Jerusalem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
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. Second, after the reduction in disruptive behaviors there should be an improvement in autism symptomatology. Improvements in behavior will allow the child to benefit more from their environments, leading to social and developmental gains. In the context of the current study, the impact of the intervention on family accommodation is also assessed, hypothesizing that by learning how to analyse and modify behaviors, parents are gaining a broader insight into the impact their own behaviors have on that of their children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parent mediated intervention (PMI) group
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist control
Arm Type
Experimental
Arm Description
Families will be recruited and will fill out measure for 3 months prior to participation and will then join the active intervention
Arm Title
Individual
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
"Parent training for disruptive behaviors" manual (Bearss, Johnson, Handen, Butter, Lecavalier, Smith & Scahill, 2018)
Intervention Description
The intervention is a short term parent training program based on behavioral principles, which can be delivered by trained therapist. The manual includes eleven core sessions, home visit session, follow-up telephone booster sessions and seven supplemental sessions, designed to be delivered individually to parents in an outpatient setting. The protocol will be administered to groups of 3-4 parents, with a quantitative pretest-post test design evaluated at five time points, including a follow up at one month post intervention. The protocol will be administered in various community and educational locations, such as schools and community centers
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
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
Title
Home Situations Questionnaire (HSQ) (Barkley & Murphy, 1998)
Description
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.
Time Frame
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.
Title
Social Responsiveness Scale (SRS) (Constantino & Gruber, 2005)
Description
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)
Time Frame
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.
Title
Adaptive Behavior Assessment System (ABAS-II)
Description
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.
Time Frame
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.
Secondary Outcome Measure Information:
Title
Parenting Stress Index Short Version (PSI-SR) (Abidin, 1990)
Description
A self-report inventory designed to measure the overall level of parenting stress an individual is experiencing and it examine stressors associated specifically with the parental role and do not include stresses associated with other life roles and events. The PSI-SR has strong psychometric properties and has been used in a number of studies of autism and parent training, and was also found valid and reliable when tested on Israeli parents (sharf 1989; Turkel 2002). It contains 36 items, each rated on a five-point Likert scale (1-5), with higher scores indicative of more parenting stress and includes Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI) and Difficult Child (DC) sub-scales.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Formal ASD diagnosis Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eyal Y Cohen, MA
Phone
0525212066
Email
eyal.cohen2@mail.huji.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Judah Koller, PsyD
Email
judah.koller@mail.huji.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judah Koller, PsyD
Organizational Affiliation
Hebrew University in Jerusalem
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hebrew university
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eyal Cohen, MA
Phone
0525212066
Email
eyal.cohen2@mail.huji.ac.il

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22941342
Citation
Bearss K, Johnson C, Handen B, Smith T, Scahill L. A pilot study of parent training in young children with autism spectrum disorders and disruptive behavior. J Autism Dev Disord. 2013 Apr;43(4):829-40. doi: 10.1007/s10803-012-1624-7.
Results Reference
background
PubMed Identifier
25898050
Citation
Bearss K, Johnson C, Smith T, Lecavalier L, Swiezy N, Aman M, McAdam DB, Butter E, Stillitano C, Minshawi N, Sukhodolsky DG, Mruzek DW, Turner K, Neal T, Hallett V, Mulick JA, Green B, Handen B, Deng Y, Dziura J, Scahill L. Effect of parent training vs parent education on behavioral problems in children with autism spectrum disorder: a randomized clinical trial. JAMA. 2015 Apr 21;313(15):1524-33. doi: 10.1001/jama.2015.3150. Erratum In: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.
Results Reference
background
PubMed Identifier
23772233
Citation
Bearss K, Lecavalier L, Minshawi N, Johnson C, Smith T, Handen B, Sukhodolsky D, Aman M, Swiezy N, Butter E, Scahill L. Toward an exportable parent training program for disruptive behaviors in autism spectrum disorders. Neuropsychiatry (London). 2013 Apr;3(2):169-180. doi: 10.2217/npy.13.14.
Results Reference
background
PubMed Identifier
23420407
Citation
Michelson D, Davenport C, Dretzke J, Barlow J, Day C. Do evidence-based interventions work when tested in the "real world?" A systematic review and meta-analysis of parent management training for the treatment of child disruptive behavior. Clin Child Fam Psychol Rev. 2013 Mar;16(1):18-34. doi: 10.1007/s10567-013-0128-0.
Results Reference
background
Links:
URL
https://www.rubinetwork.org/
Description
Protocol

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Group Based Parent Training for Children With Autism and Disruptive Behaviors

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