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

NCT ID: NCT05029375

Last Updated: 2023-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-28

Study Completion Date

2023-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Spectrum Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two parallel intervention groups differing in parental involvement
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

immediate parental involvement

Parental involvement in training is parallel to children's training

Group Type EXPERIMENTAL

PEERS® for Preschoolers

Intervention Type BEHAVIORAL

P4P is a 16-week manualized social skills treatment program, adapted from an existing empirically supported social skills intervention for young children with autism

delayed parental involvement

Parental involvement in training will be given at the end of the children's training

Group Type EXPERIMENTAL

PEERS® for Preschoolers

Intervention Type BEHAVIORAL

P4P is a 16-week manualized social skills treatment program, adapted from an existing empirically supported social skills intervention for young children with autism

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

P4P

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* severe behavioral problems
Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Israel Science Foundation

OTHER

Sponsor Role collaborator

Bar-Ilan University, Israel

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ofer Golan, Phd

Role: PRINCIPAL_INVESTIGATOR

Bar Ilan Univercity

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bar-Ilan University

Ramat Gan, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Liron Oliver Aronson, M.A

Role: CONTACT

972 03-531-7941

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Liron Oliver Aronson, M.A

Role: primary

9725855508

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

205698

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.