Group Based Parent Training for Children With Autism and Disruptive Behaviors

NCT04097457 | Unknown

• 1 other identifier: GroupPT ASD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (4)

• 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.

  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

• 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.

  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.

• 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)

  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.

• 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.

  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 Outcomes (1)

• 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.

Study Arms (3)

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.

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

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

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

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.

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

Interventions

"Parent training for disruptive behaviors" manual (Bearss, Johnson, Handen, Butter, Lecavalier, Smith & Scahill, 2018) BEHAVIORAL

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

Individual; Parent mediated intervention (PMI) group; Waitlist control

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Formal ASD diagnosis

Sponsors & Collaborators

• Hebrew University of Jerusalem: lead

Study Sites (1)

The Hebrew university

Jerusalem, Israel

RECRUITING

Related Publications (4)

• 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.

  PMID: 22941342 BACKGROUND

• 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.

  PMID: 25898050 BACKGROUND

• 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.

  PMID: 23772233 BACKGROUND

• 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.

  PMID: 23420407 BACKGROUND

Related Links

• Protocol

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Butter

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats; Fats; Lipids; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Judah Koller, PsyD

  Hebrew University in Jerusalem

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eyal Y Cohen, MA

CONTACT

0525212066; eyal.cohen2@mail.huji.ac.il

Judah Koller, PsyD

CONTACT

judah.koller@mail.huji.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study coordinator

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 20, 2019
• Study Start: October 2, 2017
• Primary Completion: September 2, 2020
• Study Completion: January 2, 2021
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)