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Parent Language Intervention for Autism

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ClinicalTrials.gov Identifier: NCT02632773
Recruitment Status : Recruiting
First Posted : December 17, 2015
Last Update Posted : September 13, 2017
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Megan Roberts, Northwestern University

Brief Summary:
Improving social communication outcomes for children with autism spectrum disorders (ASD) has important public health implications. The proposed research is a randomized controlled trial of 108 children with ASD that examines how specific parent characteristics influence outcomes of two different parent-mediated language interventions. Evaluating effective language intervention strategies for children with ASD supports NIDCD's mission of behavioral research aimed to remediate the disordered process of language development in children with ASD.

Condition or disease Intervention/treatment Phase
Autism Behavioral: Responsive Intervention Behavioral: Directive Intervention Not Applicable

Detailed Description:
High dosage of early intervention is critical to language skill development in young children with autism spectrum disorders (ASD) and including parents is a cost-effective approach to maximize intervention dosage. However, parent-mediated interventions have inconsistent effects on parent and child outcomes. This variability is likely because parents do not have the same training as clinicians and little effort has been spent examining parent characteristics that may influence their ability to implement different types of intervention strategies. Given the known cognitive, personality and language features present among many parents of children with ASD, examining the relationship between learning styles in parents and their implementation of different parent-mediated intervention strategies is an important first step in identifying potential sources of variability in parent-mediated intervention outcomes. The objective of the proposed study is to examine how parent learning style influences parent use of language intervention strategies and subsequent child language skills. The central hypothesis is that the parent learning style will be associated with: (a) differential use of language intervention strategies and (b) child language skills. The specific aims include determining the extent to which: (a) parent learning style and type of parent-mediated intervention are associated with mother use of language intervention strategies and subsequent child language skills, (b) parent learning style moderates the relationship between intervention type and mother use of language intervention strategies, and (c) parent learning style is associated with their use of language intervention strategies and their children's language skills. The proposed study will enroll 108 children with ASD between 24 and 36 months of age and their mothers. Mother-child dyads will be randomly assigned to one of two parent-mediated intervention strategies that are contrasted in their theoretical approach (responsive-developmental, directive-behavioral). Mother-child dyads will be assessed before randomization (pre-test), after intervention (post-test) and 3 months after the end of intervention to monitor maintenance. Children in both groups will receive 8 weekly intervention sessions at home using the same experimental procedures. The proposed research is significant because it will be the first examination of the impact of parent learning style on both parent and child outcomes of two different parent-mediated intervention strategies (directive, responsive). Understanding the effects of parent learning style on parent use of intervention strategies and subsequent child language skills is a key step in customizing parent-mediated interventions based on parent characteristics. The long-term positive effect of the proposed research is to improve language outcomes of interventions for children with autism by tailoring parent-mediated interventions that capitalize on parental strengths.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Parent Phenotype in Parent-Mediated Language Interventions for Autism
Study Start Date : August 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: Parent Learning Style 1
Mothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group.
Behavioral: Responsive Intervention
Mothers assigned to the responsive experimental condition will learn how to talk about what is in their child's focus of attention and to respond to all child communicative attempts by either: (a) assigning a presumed meaning to preverbal communication or vocalizations or (b) by repeating the child's verbal communication and adding words.

Experimental: Parent Learning Style 2
Mothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group.
Behavioral: Responsive Intervention
Mothers assigned to the responsive experimental condition will learn how to talk about what is in their child's focus of attention and to respond to all child communicative attempts by either: (a) assigning a presumed meaning to preverbal communication or vocalizations or (b) by repeating the child's verbal communication and adding words.

Learning Style 1 (Parent)
Mothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group.
Behavioral: Directive Intervention
Mothers assigned to the directive experimental condition will learn how to: (a) set up a prompting trial through management of toys or by responding to a child request, (b) recruit the child's attention, (c) provide a discriminative stimulus (cue), (d) wait for the child's response for 5 seconds, (e) reinforce the child for correct production of the target or provide additional prompts after incorrect productions. Parents will perform one prompting trial per minute for a total of 20 trials per parent session.

Learning Style 2 (Parent)
Mothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group.
Behavioral: Directive Intervention
Mothers assigned to the directive experimental condition will learn how to: (a) set up a prompting trial through management of toys or by responding to a child request, (b) recruit the child's attention, (c) provide a discriminative stimulus (cue), (d) wait for the child's response for 5 seconds, (e) reinforce the child for correct production of the target or provide additional prompts after incorrect productions. Parents will perform one prompting trial per minute for a total of 20 trials per parent session.




Primary Outcome Measures :
  1. Parent Use of Language Support Strategies (Mother-child interaction) [ Time Frame: Two months after the start of the study ]
    Mother use of intervention strategies will be measured by transcribing and coding mother behaviors during parent-child interactions.


Secondary Outcome Measures :
  1. Expressive vocabulary of the child as measured by transcribing and coding a 20 minute video of a therapist-child interaction in the clinic with a standard set of age-appropriate toys. [ Time Frame: Two months after the start of the study ]
    20 minute video of a therapist-child interaction in the clinic with a standard set of age-appropriate toys.

  2. MacArthur-Bates Communicative Development Inventory (MCDI) (Child) [ Time Frame: Two months after the start of the study ]
    Parent report of child's expressive vocabulary and prelinguistic communication skills



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Ages Eligible for Study:   18 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Child inclusion criteria include:

  • diagnosis of ASD based on ADOS
  • chronological age of less than 48 months
  • a parent who is willing to learn intervention strategies
  • English as the primary language spoken in the home

Parent Inclusion Criteria Include:

- Mother

Exclusion Criteria:

  • Children or parents with additional impairments (e.g., blindness, deafness, genetic syndromes) will be excluded from the study.
  • Fathers or caregivers other than the child's Mother will be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632773


Contacts
Contact: Megan Y Roberts, PhD 847-491-3183 megan.y.roberts@northwestern.edu
Contact: Laura J Sudec, MSW 847-491-3183 ei@northwestern.edu

Locations
United States, Colorado
Northwestern University Not yet recruiting
Denver, Colorado, United States, 80012
Contact: Megan Y Roberts, PhD    847-491-3183    megan.y.roberts@northwestern.edu   
Contact: Laura J Sudec, MSW    847-491-3183    ei@northwestern.edu   
United States, Illinois
Northwestern University Recruiting
Evanston, Illinois, United States, 60208
Contact: Megan Y Roberts, PhD    847-491-3183    megan.y.roberts@northwestern.edu   
Contact: Laura J Sudec, MSW    847-491-3183    ei@northwestern.edu   
Principal Investigator: Megan Y Roberts, PhD         
Sponsors and Collaborators
Northwestern University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Megan Y Roberts, PhD Northwestern University

Publications:
Responsible Party: Megan Roberts, Jane Steiner Hoffman and Michael Hoffman Assistant Professor of Communication Sciences and Disorders, Northwestern University
ClinicalTrials.gov Identifier: NCT02632773     History of Changes
Other Study ID Numbers: 1R01DC014709-01 ( U.S. NIH Grant/Contract )
1R01DC014709-01 ( U.S. NIH Grant/Contract )
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Sharing baseline data with the National Database for Autism Research (NDAR) semi-annually.

Keywords provided by Megan Roberts, Northwestern University:
Language Intervention
Parent-Mediated Intervention

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders