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

Autism Spectrum Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05029375
• Other study ID #: 205698
• Status: Recruiting
• Phase: N/A
• Start date: August 28, 2021
• Est. completion date: October 2023

Study information

• Verified date: March 2022
• Source: Bar-Ilan University, Israel
• Contact: Liron Oliver Aronson, M.A
• Phone: 972 03-531-7941
• Email: liron.oliver[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: October 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• severe behavioral problems

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

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

Locations

Country	Name	City	State
Israel	Bar-Ilan University	Ramat-Gan

Sponsors (2)

Lead Sponsor	Collaborator
Bar-Ilan University, Israel	Israel Science Foundation

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral peer interaction measurement	The interaction will be videotaped and microanalytically coded for frequency and duration of child behaviors, using a designated computerized system	Immediate post intervention assessment
Primary	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)	Immediate post intervention assessment
Primary	Behavioral peer interaction measurement	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
Primary	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	10 weeks post intervention (follow up) assessment
Secondary	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	Immediate post intervention assessment
Secondary	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	10 weeks post intervention (follow up) assessment
Secondary	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	Immediate post intervention assessment
Secondary	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	10 weeks post intervention (follow up) assessment
Secondary	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	Immediate post intervention assessment
Secondary	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	10 weeks post intervention (follow up) assessment
Secondary	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	Immediate post intervention assessment
Secondary	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	10 weeks post intervention (follow up) assessment