NCT05029375

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

August 28, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2022

Enrollment Period

1.9 years

First QC Date

August 12, 2021

Last Update Submit

March 13, 2023

Conditions

Keywords

Autism, Random Clinical Trial, parental insightfulness

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (8)

  • Social Responsiveness Scale-second edition (Constantino & Gruber, 2012)

    Immediate post intervention assessment

  • Social Responsiveness Scale-second edition (Constantino & Gruber, 2012)

    10 weeks post intervention (follow up) assessment

  • The Social Skills Improvement System (SSIS; Gresham & Elliott, 2008)

    Immediate post intervention assessment

  • The Social Skills Improvement System (SSIS; Gresham & Elliott, 2008)

    10 weeks post intervention (follow up) assessment

  • Quality of Play Questionnaire (QPQ; Frankel & Mintz, 2011).

    Immediate post intervention assessment

  • +3 more secondary outcomes

Study Arms (2)

immediate parental involvement

EXPERIMENTAL

Parental involvement in training is parallel to children's training

Behavioral: PEERS® for Preschoolers

delayed parental involvement

EXPERIMENTAL

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

Behavioral: PEERS® for Preschoolers

Interventions

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

Also known as: P4P
delayed parental involvementimmediate parental involvement

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • severe behavioral problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bar-Ilan University

Ramat Gan, 5290002, Israel

RECRUITING

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Ofer Golan, Phd

    Bar Ilan Univercity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liron Oliver Aronson, M.A

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two parallel intervention groups differing in parental involvement
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2021

First Posted

August 31, 2021

Study Start

August 28, 2021

Primary Completion

August 1, 2023

Study Completion

October 1, 2023

Last Updated

March 14, 2023

Record last verified: 2022-03

Locations