Parental Insightfulness and the Acquisition of Social Skills in Children With ASD. (ASD)
Primary Purpose
Autism Spectrum Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
PEERS® for Preschoolers
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism, Random Clinical Trial, parental insightfulness
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Autism spectrum disorder
- no cooccurring intellectual impairment
Exclusion Criteria:
- severe behavioral problems
Sites / Locations
- Bar-Ilan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
immediate parental involvement
delayed parental involvement
Arm Description
Parental involvement in training is parallel to children's training
Parental involvement in training will be given at the end of the children's training
Outcomes
Primary Outcome Measures
Behavioral peer interaction measurement
The interaction will be videotaped and microanalytically coded for frequency and duration of child behaviors, using a designated computerized system
Insightfulness 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)
Behavioral peer interaction measurement
The interaction will be videotaped and microanalytically coded for frequency and duration of child behaviors, using a designated computerized system
Insightfulness 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
Secondary Outcome Measures
Social Responsiveness Scale-second edition (Constantino & Gruber, 2012)
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
Social Responsiveness Scale-second edition (Constantino & Gruber, 2012)
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
The Social Skills Improvement System (SSIS; Gresham & Elliott, 2008)
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
The Social Skills Improvement System (SSIS; Gresham & Elliott, 2008)
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
Quality of Play Questionnaire (QPQ; Frankel & Mintz, 2011).
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
Quality of Play Questionnaire (QPQ; Frankel & Mintz, 2011).
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
The Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens & Fonagy, 2017).
Items are rated on a 7-point Likert scale. Minimun value is 1, maximum value is 7. higher scores mean better outcome
The Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens & Fonagy, 2017).
Items are rated on a 7-point Likert scale. Minimun value is 1, maximum value is 7. higher scores mean better outcome
Full Information
NCT ID
NCT05029375
First Posted
August 12, 2021
Last Updated
March 13, 2023
Sponsor
Bar-Ilan University, Israel
Collaborators
Israel Science Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05029375
Brief Title
Parental Insightfulness and the Acquisition of Social Skills in Children With ASD.
Acronym
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bar-Ilan University, Israel
Collaborators
Israel Science Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism, Random Clinical Trial, parental insightfulness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two parallel intervention groups differing in parental involvement
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
immediate parental involvement
Arm Type
Experimental
Arm Description
Parental involvement in training is parallel to children's training
Arm Title
delayed parental involvement
Arm Type
Experimental
Arm Description
Parental involvement in training will be given at the end of the children's training
Intervention Type
Behavioral
Intervention Name(s)
PEERS® for Preschoolers
Other Intervention Name(s)
P4P
Intervention Description
P4P is a 16-week manualized social skills treatment program, adapted from an existing empirically supported social skills intervention for young children with autism
Primary Outcome Measure Information:
Title
Behavioral peer interaction measurement
Description
The interaction will be videotaped and microanalytically coded for frequency and duration of child behaviors, using a designated computerized system
Time Frame
Immediate post intervention assessment
Title
Insightfulness Assessment
Description
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)
Time Frame
Immediate post intervention assessment
Title
Behavioral peer interaction measurement
Description
The interaction will be videotaped and microanalytically coded for frequency and duration of child behaviors, using a designated computerized system
Time Frame
10 weeks post intervention (follow up) assessment
Title
Insightfulness Assessment
Description
IA (InsightfulneIA (Insightfulness Assessment) transcripts are scored on ten 9-point rating scales ss Assessment) transcripts are scored on ten 9-point rating scales
Time Frame
10 weeks post intervention (follow up) assessment
Secondary Outcome Measure Information:
Title
Social Responsiveness Scale-second edition (Constantino & Gruber, 2012)
Description
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
Time Frame
Immediate post intervention assessment
Title
Social Responsiveness Scale-second edition (Constantino & Gruber, 2012)
Description
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
Time Frame
10 weeks post intervention (follow up) assessment
Title
The Social Skills Improvement System (SSIS; Gresham & Elliott, 2008)
Description
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
Time Frame
Immediate post intervention assessment
Title
The Social Skills Improvement System (SSIS; Gresham & Elliott, 2008)
Description
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
Time Frame
10 weeks post intervention (follow up) assessment
Title
Quality of Play Questionnaire (QPQ; Frankel & Mintz, 2011).
Description
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
Time Frame
Immediate post intervention assessment
Title
Quality of Play Questionnaire (QPQ; Frankel & Mintz, 2011).
Description
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
Time Frame
10 weeks post intervention (follow up) assessment
Title
The Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens & Fonagy, 2017).
Description
Items are rated on a 7-point Likert scale. Minimun value is 1, maximum value is 7. higher scores mean better outcome
Time Frame
Immediate post intervention assessment
Title
The Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens & Fonagy, 2017).
Description
Items are rated on a 7-point Likert scale. Minimun value is 1, maximum value is 7. higher scores mean better outcome
Time Frame
10 weeks post intervention (follow up) assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Autism spectrum disorder
no cooccurring intellectual impairment
Exclusion Criteria:
severe behavioral problems
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liron Oliver Aronson, M.A
Phone
972 03-531-7941
Email
liron.oliver@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ofer Golan, Phd
Organizational Affiliation
Bar Ilan Univercity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bar-Ilan University
City
Ramat-Gan
ZIP/Postal Code
5290002
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liron Oliver Aronson, M.A
Phone
9725855508
Email
liron.oliver@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Parental Insightfulness and the Acquisition of Social Skills in Children With ASD.
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