Parental Insightfulness and the Acquisition of Social Skills in Children With ASD. (ASD)

March 13, 2023 updated by: Bar-Ilan University, Israel

The Role of Parental Insightfulness in Enhancing the Acquisition of Social Skills in Young Children With ASD, Following a Parent Mediated Intervention

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.

Study Overview

Status

Recruiting

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.

Study Type

Interventional

Enrollment (Anticipated)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Ramat-Gan, Israel, 5290002
        • Recruiting
        • Bar-Ilan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • severe behavioral problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: immediate parental involvement
Parental involvement in training is parallel to children's training
P4P is a 16-week manualized social skills treatment program, adapted from an existing empirically supported social skills intervention for young children with autism
Other Names:
  • P4P
Experimental: delayed parental involvement
Parental involvement in training will be given at the end of the children's training
P4P is a 16-week manualized social skills treatment program, adapted from an existing empirically supported social skills intervention for young children with autism
Other Names:
  • P4P

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral peer interaction measurement
Time Frame: Immediate post intervention assessment
The interaction will be videotaped and microanalytically coded for frequency and duration of child behaviors, using a designated computerized system
Immediate post intervention assessment
Insightfulness Assessment
Time Frame: Immediate post intervention assessment
IA (Insightfulness Assessment) transcripts are scored on ten 9-point rating scales The IA (Insightfulness Assessment) provides a classification of the parent's insightfulness as either established (i.e., positively insightful) or emerging (i.e., non-insightful)
Immediate post intervention assessment
Behavioral peer interaction measurement
Time Frame: 10 weeks post intervention (follow up) assessment
The interaction will be videotaped and microanalytically coded for frequency and duration of child behaviors, using a designated computerized system
10 weeks post intervention (follow up) assessment
Insightfulness Assessment
Time Frame: 10 weeks post intervention (follow up) assessment
IA (InsightfulneIA (Insightfulness Assessment) transcripts are scored on ten 9-point rating scales ss Assessment) transcripts are scored on ten 9-point rating scales
10 weeks post intervention (follow up) assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Responsiveness Scale-second edition (Constantino & Gruber, 2012)
Time Frame: Immediate post intervention assessment
T scores can be computed for each subscale as well as for the total questionnaire, and for a social communication index. Minimun value is 1, maximum value is 4. higher scores mean worse outcome
Immediate post intervention assessment
Social Responsiveness Scale-second edition (Constantino & Gruber, 2012)
Time Frame: 10 weeks post intervention (follow up) assessment
T scores can be computed for each subscale as well as for the total questionnaire, and for a social communication index. Minimun value is 1, maximum value is 4. higher scores mean worse outcome
10 weeks post intervention (follow up) assessment
The Social Skills Improvement System (SSIS; Gresham & Elliott, 2008)
Time Frame: Immediate post intervention assessment
Two standard composite scales can be computed for Social Skills and Behavior Problems. Minimun value is 1, maximum value is 4. higher scores mean better outcome
Immediate post intervention assessment
The Social Skills Improvement System (SSIS; Gresham & Elliott, 2008)
Time Frame: 10 weeks post intervention (follow up) assessment
Two standard composite scales can be computed for Social Skills and Behavior Problems. Minimun value is 1, maximum value is 4. higher scores mean better outcome
10 weeks post intervention (follow up) assessment
Quality of Play Questionnaire (QPQ; Frankel & Mintz, 2011).
Time Frame: Immediate post intervention assessment
An Engagement Scale measures the extent that the child engaged in talk and physical interaction with the peer, and a Conflict Scale measures the degree of conflict between peers during the last play date. Minimun value is 0, maximum value is 3. higher scores mean better outcome
Immediate post intervention assessment
Quality of Play Questionnaire (QPQ; Frankel & Mintz, 2011).
Time Frame: 10 weeks post intervention (follow up) assessment
An Engagement Scale measures the extent that the child engaged in talk and physical interaction with the peer, and a Conflict Scale measures the degree of conflict between peers during the last play date. Minimun value is 0, maximum value is 3. higher scores mean better outcome
10 weeks post intervention (follow up) assessment
The Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens & Fonagy, 2017).
Time Frame: Immediate post intervention assessment
Items are rated on a 7-point Likert scale. Minimun value is 1, maximum value is 7. higher scores mean better outcome
Immediate post intervention assessment
The Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens & Fonagy, 2017).
Time Frame: 10 weeks post intervention (follow up) assessment
Items are rated on a 7-point Likert scale. Minimun value is 1, maximum value is 7. higher scores mean better outcome
10 weeks post intervention (follow up) assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ofer Golan, Phd, Bar Ilan Univercity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2021

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

August 12, 2021

First Submitted That Met QC Criteria

August 25, 2021

First Posted (Actual)

August 31, 2021

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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