- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02632773
Parent Language Intervention for Autism
July 15, 2021 updated by: Megan Roberts, Northwestern University
The Role of Parent Phenotype in Parent-Mediated Language Interventions for Autism
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Evanston, Illinois, United States, 60208
- Northwestern University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 4 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
Other: Learning Style 1 (Parent)
Mothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group.
|
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.
|
Other: Learning Style 2 (Parent)
Mothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Two months after the start of the study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Two months after the start of the study
|
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
|
Two months after the start of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Megan Y Roberts, PhD, Northwestern University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2015
Primary Completion (Actual)
March 1, 2020
Study Completion (Actual)
March 1, 2020
Study Registration Dates
First Submitted
December 8, 2015
First Submitted That Met QC Criteria
December 16, 2015
First Posted (Estimate)
December 17, 2015
Study Record Updates
Last Update Posted (Actual)
July 16, 2021
Last Update Submitted That Met QC Criteria
July 15, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01DC014709-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Sharing baseline data with the National Database for Autism Research (NDAR) semi-annually.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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