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

Sponsor
Bar-Ilan University, Israel (Other)
Overall Status
Recruiting
CT.gov ID
NCT05029375
Collaborator
Israel Science Foundation (Other)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: PEERS® for Preschoolers
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
two parallel intervention groups differing in parental involvementtwo parallel intervention groups differing in parental involvement
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Role of Parental Insightfulness in Enhancing the Acquisition of Social Skills in Young Children With ASD, Following a Parent Mediated Intervention
Anticipated Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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
  • Outcome Measures

    Primary Outcome Measures

    1. Behavioral peer interaction measurement [Immediate post intervention assessment]

      The interaction will be videotaped and microanalytically coded for frequency and duration of child behaviors, using a designated computerized system

    2. Insightfulness Assessment [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)

    3. Behavioral peer interaction measurement [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

    4. Insightfulness Assessment [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

    Secondary Outcome Measures

    1. Social Responsiveness Scale-second edition (Constantino & Gruber, 2012) [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

    2. Social Responsiveness Scale-second edition (Constantino & Gruber, 2012) [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

    3. The Social Skills Improvement System (SSIS; Gresham & Elliott, 2008) [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

    4. The Social Skills Improvement System (SSIS; Gresham & Elliott, 2008) [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

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

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

    7. The Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens & Fonagy, 2017). [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

    8. The Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens & Fonagy, 2017). [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 8 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Clinical diagnosis of Autism spectrum disorder

    • no cooccurring intellectual impairment

    Exclusion Criteria:
    • severe behavioral problems

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bar-Ilan University Ramat-Gan Israel 5290002

    Sponsors and Collaborators

    • Bar-Ilan University, Israel
    • Israel Science Foundation

    Investigators

    • Principal Investigator: Ofer Golan, Phd, Bar Ilan Univercity

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bar-Ilan University, Israel
    ClinicalTrials.gov Identifier:
    NCT05029375
    Other Study ID Numbers:
    • 205698
    First Posted:
    Aug 31, 2021
    Last Update Posted:
    Aug 31, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bar-Ilan University, Israel
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 31, 2021