NCT03354923

Brief Summary

Early adolescence marks a significant development in teens' social abilities, shifting from play to conversation-based activities, and having stronger and more intimate friendships. Parents contribute to this shift by practicing reciprocal social interaction with their teens. For teens with Autism Spectrum Disorder (ASD) this shift in their peers' social abilities extends their characteristic social deficits even further. Social skills deficits in individuals with ASD are associated with poor adaptive functioning and increased psychopathology. Parents play a pivotal role in caring for and tutoring their children with ASD into adulthood. However, the effect parent-teen reciprocity has on the social skills of adolescents with ASD has not been tested. Furthermore, whereas parent-child reciprocity predicted intervention outcome in young children with ASD, no study has examined this effect in teens with ASD. The proposed study aims to test these questions using the Program for the Education and Enrichment of Relational Skills (PEERS), an evidence-based parent-assisted social skills training program for teens with ASD.

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2017

Completed
10 months until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

2.6 years

First QC Date

January 29, 2017

Last Update Submit

February 25, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change from baseline Parent-Adolescent reciprocity paradigm at 4 and 8 months

    This paradigm is designed to test dyadic reciprocity between a parent and an adolescent. Adolescents will be observed in three 10-minute discussions (one positive, one support giving and one negative) with the parent who serves as their PEERS coach: In the positive discussion, parent and teen will be asked to plan a fun outing together. In the support giving the parent and child take turns and each tells the other something sad/disappointing that happened to him/her outside the relationship (with friends, boss, etc.) and the other gives support. After five minutes partners change roles. In the negative discussion they will be asked about a common conflict between them and negotiate it. The three discussions will be videotaped and coded using the Coding Interactive Behavior manual (Feldman, 1998). The CIB is a global rating system for social interactions that includes 52 codes rated on a scale of 1 to 5 which are aggregated into several composites

    Day 0, 4 months and 8 months

  • Change from baseline Contextual Assessment of Social Skills at 4 and 8 months

    The CASS is a live role-play assessment of conversational skills developed for adolescents with high-functioning ASD. Conversational skills are assessed via behavioral coding of two semi-structured role-plays (with an interested companion and with a bored companion) and scores on a conversation rating scale. Behaviors coded during the role plays include asking questions, topic changes, vocal expressiveness, gestures, positive affect, posture, kinesics arousal, social anxiety, involvement in the conversation, quality of rapport, and an overall score. Psychometric properties of the CASS are good, with mean internal consistency of .83 and mean inter-rater reliability of .68. The CASS was reported as a sensitive measure of change in an evaluation of a social skills program for young adults with ASD (White, Scarpa, Conner, Maddox, \& Bonete, 2014).

    Day 0, 4 months and 8 months

Secondary Outcomes (11)

  • Change from baseline Social Responsiveness Scale at 4 and 8 months

    Day 0, 4 months and 8 months

  • Change from baseline The Social Skills Improvement System at 4 and 8 months

    Day 0, 4 months and 8 months

  • Change from baseline Friendship Qualities Scale

    Day 0, 4 months and 8 months

  • Change from baseline Quality of Play Questionnaire at 4 and 8 months

    Day 0, 4 months and 8 months

  • Change from baseline Test of Adolescent Social Skills Knowledge at 4 and 8 months

    Day 0, 4 months and 8 months

  • +6 more secondary outcomes

Study Arms (2)

immediate intervention group

EXPERIMENTAL

Immediate PEERS intervention

Behavioral: PEERS intervention

delayed intervention

OTHER

delayed PEERS intervention to begin after experimental group

Behavioral: PEERS intervention

Interventions

PEERS is a 14-week manualized social skills treatment program that targets the friendship skills of adolescents with ASD. In the Israeli adaptation of PEERS, two meeting were extended. An adolescents group will be held concurrently with the parents group in different rooms. Both groups will begin the session with homework review, followed by a didactic social skills lesson, utilizing the teaching methods of modeling and role-playing. In order to practice the newly learned social skills,a behavioral rehearsal interaction will be assigned in the adolescents group. Finally,Socialization homework assignments designed to address further mastery and generalization of newly learned skills within the natural social environment will be assigned too.

delayed interventionimmediate intervention group

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Capable and willing to provide informed assent
  • Diagnosed with ASD (high functioning)
  • IQ \> 80

You may not qualify if:

  • Intellectual Disability
  • History of significant head injury or neurological illness
  • Current diagnosis of substance dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bar Ilan University

Ramat Gan, 5290002, Israel

Location

Related Publications (51)

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    BACKGROUND
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    RESULT
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    RESULT
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    RESULT
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    RESULT
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    RESULT
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  • Laugeson, E. A., & Frankel, F. (unpublished). Test of adolescent social skills knowledge-revised. (Available from UCLA Parenting and Children's Friendship Program, 300 Medical Plaza, Los Angeles, CA 90095, USA).

    RESULT

MeSH Terms

Conditions

Social Skills

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Irit Mor, MD

    Association for Children at Risk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Ofer Golan

Study Record Dates

First Submitted

January 29, 2017

First Posted

November 28, 2017

Study Start

January 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2019

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations