Clinical trial NCT04097457: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Formal ASD diagnosis

Exclusion Criteria:

-

Primary outcomes:
measure: 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)
timeFrame: 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
measure: Home Situations Questionnaire (HSQ) (Barkley & Murphy, 1998)
timeFrame: 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.
measure: Social Responsiveness Scale (SRS) (Constantino & Gruber, 2005)
timeFrame: 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.
measure: Adaptive Behavior Assessment System (ABAS-II)
timeFrame: 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:
measure: Parenting Stress Index Short Version (PSI-SR) (Abidin, 1990)
timeFrame: 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.
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: The Hebrew university
Study officials:
affiliation: Hebrew University in Jerusalem
name: Judah Koller, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.