Clinical trial NCT05029375: Parental Insightfulness and the Acquisition of Social Skills in Children With ASD.
Official title: The Role of Parental Insightfulness in Enhancing the Acquisition of Social Skills in Young Children With ASD, Following a Parent Mediated Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism, Random Clinical Trial, parental insightfulness
Lead sponsor: Bar-Ilan University, Israel
Sponsor class: OTHER
Collaborators: name: Israel Science Foundation
First posted: 2021-08-31
Enrollment: 85
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two parallel intervention groups differing in parental involvement
Primary purpose: TREATMENT

Brief summary: Parental Insightfulness (PI), promotes the development of the child's socio-emotional competence and her ability to have productive and sustaining relationships. PI is even more central in the case of young children with ASD, who struggle to socially communicate their needs and their mental and emotional states. PI's effects on the child's peer-interaction have not been tested and Since parents play a central role in intervention programs for their children with ASD, examining modifiable parent factors as mediators and moderators of treatment effectiveness could contribute to this line of research. The proposed study aims to test how pre intervention PI and intervention-related changes in PI affect parents' ability to support their children in the acquisition of peer-interaction skills. Using the PEERS for Preschoolers (P4P) program, the study will examine the effect of PI and parental involvement in a social skills intervention on children's acquisition and maintenance of social skills.

Detailed description: Parental Insightfulness (PI), the ability to see things from the child's point of view and to think about the motives that underlie the child's behavior, promotes the development of the child's socio-emotional competence and her ability to have productive and sustaining relationships. PI may be even more central in the case of young children with Autism Spectrum Disorder (ASD), who struggle to socially communicate their needs and their mental and emotional states. Previous research showed PI predicts adaptive child functioning and demonstrated the merit of PI both as a moderator and as a mediator of treatment outcomes in interventions that aim to promote PI and parent-child interaction. However, PI's effects on the child's peer-interaction have not been tested. Intervention research in ASD has evolved from the examination of treatment effectiveness to the pursuit of treatment mediators and moderators, that could be utilized for treatment individualization. Since parents play a central role in intervention programs for their children with ASD, examining modifiable parent factors as mediators and moderators of treatment effectiveness could contribute to this line of research. The proposed study aims to test how pre intervention PI and intervention-related changes in PI affect parents' ability to support their children in the acquisition of peer-interaction skills. Using the PEERS for Preschoolers (P4P) program, a parent assisted social skills training program for young children with ASD, the study will examine the effect of PI and parental involvement in a social skills intervention on children's acquisition and maintenance of social skills.

These aims will be tested in the following ways: 1) A randomized controlled trial will compare the effects of the parent-mediated P4P program to those of a P4P program with minimal parent involvement (P4P-mpi) on the outcome and the maintenance of gains in child social skills and on PI. 2) an examination of the role of pretreatment PI as a moderator of children's intervention-related social skills gains and their maintenance, and 3) an examination of the role of treatment related change in PI as a mediator of children's intervention-related social skills gains and their maintenance.

The trial will include 80 young children with ASD, aged 4-7, and their parents, who will be randomized into a P4P treatment group and a P4P-mpi control group. Participants will be tested pre- and post- a 16-week intervention period, as well as 10 weeks later, for follow up. Measures will include a behavioral microanalytic assessment of a peer play interaction and parental insightfulness assessment, a parental reflective functioning questionnaire, and social skills questionnaires filled out by parents and teachers. This study may promote the yet limited research on parent-mediated social skills interventions in young children with ASD and shed light on the role of parental insightfulness in children's treatment-related outcomes.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Autism spectrum disorder
* no cooccurring intellectual impairment

Exclusion Criteria:

* severe behavioral problems

Primary outcomes:
measure: Behavioral peer interaction measurement
timeFrame: Immediate post intervention assessment
measure: Insightfulness Assessment
timeFrame: Immediate post intervention assessment
measure: Behavioral peer interaction measurement
timeFrame: 10 weeks post intervention (follow up) assessment
measure: Insightfulness Assessment
timeFrame: 10 weeks post intervention (follow up) assessment
Secondary outcomes:
measure: Social Responsiveness Scale-second edition (Constantino & Gruber, 2012)
timeFrame: Immediate post intervention assessment
measure: Social Responsiveness Scale-second edition (Constantino & Gruber, 2012)
timeFrame: 10 weeks post intervention (follow up) assessment
measure: The Social Skills Improvement System (SSIS; Gresham & Elliott, 2008)
timeFrame: Immediate post intervention assessment
measure: The Social Skills Improvement System (SSIS; Gresham & Elliott, 2008)
timeFrame: 10 weeks post intervention (follow up) assessment
measure: Quality of Play Questionnaire (QPQ; Frankel & Mintz, 2011).
timeFrame: Immediate post intervention assessment
measure: Quality of Play Questionnaire (QPQ; Frankel & Mintz, 2011).
timeFrame: 10 weeks post intervention (follow up) assessment
measure: The Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens & Fonagy, 2017).
timeFrame: Immediate post intervention assessment
measure: The Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens & Fonagy, 2017).
timeFrame: 10 weeks post intervention (follow up) assessment
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Bar-Ilan University
Study officials:
affiliation: Bar Ilan Univercity
name: Ofer Golan, Phd
role: PRINCIPAL_INVESTIGATOR
References: