Autism Spectrum DisorderASDNCT05029375
Parental Insightfulness and the Acquisition of Social Skills in Children With ASD.
A study testing PEERS® for Preschoolers in people with Autism Spectrum Disorder, run by Bar-Ilan University, Israel at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- PEERS® for Preschoolers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Aug 2021to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinical diagnosis of Autism spectrum disorder
- no cooccurring intellectual impairment
Who cannot join
- severe behavioral problems
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Bar-Ilan University
Ramat Gan, 5290002
Liron Oliver Aronson, M.A, 9725855508, liron.oliver@gmail.com
About this study
Official title: The Role of Parental Insightfulness in Enhancing the Acquisition of Social Skills in Young Children With ASD, Following a Parent Mediated Intervention
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- PEERS® for Preschoolers
- Keywords
- Autism, Random Clinical Trial, parental insightfulness
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEERS® for PreschoolersBehavioural
Also called P4P
P4P is a 16-week manualized social skills treatment program, adapted from an existing empirically supported social skills intervention for young children with autism
| Study group | Role | What they receive |
|---|---|---|
| immediate parental involvement | Experimental | Parental involvement in training is parallel to children's training Receives: Behavioral: PEERS® for Preschoolers |
| delayed parental involvement | Experimental | Parental involvement in training will be given at the end of the children's training Receives: Behavioral: PEERS® for Preschoolers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral peer interaction measurement
The interaction will be videotaped and microanalytically coded for frequency and duration of child behaviors, using a designated computerized system
Measured: 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)
Measured: 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
Measured: 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
Measured: 10 weeks post intervention (follow up) assessment
Secondary outcomes (8)
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
Measured: Immediate post intervention assessment
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
Measured: 10 weeks post intervention (follow up) assessment
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
Measured: Immediate post intervention assessment
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
Measured: 10 weeks post intervention (follow up) assessment
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
Measured: Immediate post intervention assessment
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
Measured: 10 weeks post intervention (follow up) assessment
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
Measured: Immediate post intervention assessment
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
Measured: 10 weeks post intervention (follow up) assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start28 Aug 2021
- Primary completionAug 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two parallel intervention groups differing in parental involvement
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bar-Ilan University, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- Israel Science Foundation
- Responsible party
- Sponsor
- Investigators
- Ofer Golan, Phd, Principal investigator, Bar Ilan Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029375
- Sponsor's protocol ID
- 205698
- Acronym
- ASD
- Status last verified
- Mar 2022
- First submitted
- 12 Aug 2021
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Parental Insightfulness in Enhancing the Acquisition of Social Skills in Young Children With ASD, Following a Parent Mediated Intervention
- ClinicalTrials.gov ID
- NCT05029375
- Acronym / sponsor ID
- ASD / 205698
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism, Random Clinical Trial, parental insightfulness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Bar-Ilan University, IsraelUniversity, hospital or other
- Collaborators
- Israel Science Foundation
- Study start
- 28 Aug 2021 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- two parallel intervention groups differing in parental involvement
| Arm | Type | Receives |
|---|---|---|
| immediate parental involvement | Experimental | Behavioral: PEERS® for PreschoolersParental involvement in training is parallel to children's training |
| delayed parental involvement | Experimental | Behavioral: PEERS® for PreschoolersParental involvement in training will be given at the end of the children's training |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clinical diagnosis of Autism spectrum disorder
- no cooccurring intellectual impairment
Key exclusion criteria (1 listed)
- severe behavioral problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEERS® for PreschoolersAlso: P4PP4P is a 16-week manualized social skills treatment program, adapted from an existing empirically supported social skills intervention for young children with autism | Behavioural | delayed parental involvement, immediate parental involvement |
Primary outcome
Behavioral peer interaction measurement
Time frame: Immediate post intervention assessment
The interaction will be videotaped and microanalytically coded for frequency and duration of child behaviors, using a designated computerized system
Insightfulness Assessment
Time frame: 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)
Behavioral peer interaction measurement
Time frame: 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
Insightfulness Assessment
Time frame: 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
8 secondary outcomes
Social Responsiveness Scale-second edition (Constantino & Gruber, 2012)
Time frame: Immediate post intervention assessment
Social Responsiveness Scale-second edition (Constantino & Gruber, 2012)
Time frame: 10 weeks post intervention (follow up) assessment
The Social Skills Improvement System (SSIS; Gresham & Elliott, 2008)
Time frame: Immediate post intervention assessment
The Social Skills Improvement System (SSIS; Gresham & Elliott, 2008)
Time frame: 10 weeks post intervention (follow up) assessment
Quality of Play Questionnaire (QPQ; Frankel & Mintz, 2011).
Time frame: Immediate post intervention assessment
Quality of Play Questionnaire (QPQ; Frankel & Mintz, 2011).
Time frame: 10 weeks post intervention (follow up) assessment
The Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens & Fonagy, 2017).
Time frame: Immediate post intervention assessment
The Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens & Fonagy, 2017).
Time frame: 10 weeks post intervention (follow up) assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ofer Golan, Phd principal investigator
Bar Ilan Univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEERS® for Preschoolers in people with Autism Spectrum Disorder, run by Bar-Ilan University, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liron Oliver Aronson, M.A (972 03-531-7941, liron.oliver@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral peer interaction measurement (time frame: Immediate post intervention assessment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.