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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Israel
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: immediate parental involvement
Parental involvement in training is parallel to children's training
Behavioral: PEERS® for Preschoolers
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
Behavioral: PEERS® for Preschoolers
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bar-Ilan University, Israel

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Israel Science Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 205698

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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