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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 : August 21, 2019
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Megan Roberts, Northwestern University

Tracking Information
First Submitted Date  ICMJE December 8, 2015
First Posted Date  ICMJE December 17, 2015
Last Update Posted Date August 21, 2019
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02632773 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2015)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Parent Language Intervention for Autism
Official Title  ICMJE The Role of Parent Phenotype in Parent-Mediated Language Interventions for Autism
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autism
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Parent Learning Style 1
    Mothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group.
    Intervention: Behavioral: Responsive Intervention
  • Experimental: Parent Learning Style 2
    Mothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group.
    Intervention: Behavioral: Responsive Intervention
  • Learning Style 1 (Parent)
    Mothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group.
    Intervention: Behavioral: Directive Intervention
  • Learning Style 2 (Parent)
    Mothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group.
    Intervention: Behavioral: Directive Intervention
Publications * Roberts MY, Kaiser AP. Early intervention for toddlers with language delays: a randomized controlled trial. Pediatrics. 2015 Apr;135(4):686-93. doi: 10.1542/peds.2014-2134. Epub 2015 Mar 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 16, 2015)
108
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Months to 48 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Megan Y Roberts, PhD 847-491-3183 megan.y.roberts@northwestern.edu
Contact: Laura J Sudec, MSW 847-491-3183 ei@northwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02632773
Other Study ID Numbers  ICMJE 1R01DC014709-01( U.S. NIH Grant/Contract )
1R01DC014709-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Sharing baseline data with the National Database for Autism Research (NDAR) semi-annually.
Responsible Party Megan Roberts, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators  ICMJE
Principal Investigator: Megan Y Roberts, PhD Northwestern University
PRS Account Northwestern University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP