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Parent Language Intervention for Autism

Primary Purpose

Autism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Responsive Intervention
Directive Intervention
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring Language Intervention, Parent-Mediated Intervention

Eligibility Criteria

18 Months - 48 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Other

Other

Arm Label

Parent Learning Style 1

Parent Learning Style 2

Learning Style 1 (Parent)

Learning Style 2 (Parent)

Arm Description

Mothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group.

Mothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group.

Mothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group.

Mothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group.

Outcomes

Primary Outcome Measures

Parent Use of Language Support Strategies (Mother-child interaction)
Mother use of intervention strategies will be measured by transcribing and coding mother behaviors during parent-child interactions.

Secondary Outcome Measures

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.
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)
Parent report of child's expressive vocabulary and prelinguistic communication skills

Full Information

First Posted
December 8, 2015
Last Updated
July 15, 2021
Sponsor
Northwestern University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT02632773
Brief Title
Parent Language Intervention for Autism
Official Title
The Role of Parent Phenotype in Parent-Mediated Language Interventions for Autism
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
Language Intervention, Parent-Mediated Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parent Learning Style 1
Arm Type
Experimental
Arm Description
Mothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group.
Arm Title
Parent Learning Style 2
Arm Type
Experimental
Arm Description
Mothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group.
Arm Title
Learning Style 1 (Parent)
Arm Type
Other
Arm Description
Mothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group.
Arm Title
Learning Style 2 (Parent)
Arm Type
Other
Arm Description
Mothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group.
Intervention Type
Behavioral
Intervention Name(s)
Responsive Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Directive Intervention
Intervention Description
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 Measure Information:
Title
Parent Use of Language Support Strategies (Mother-child interaction)
Description
Mother use of intervention strategies will be measured by transcribing and coding mother behaviors during parent-child interactions.
Time Frame
Two months after the start of the study
Secondary Outcome Measure Information:
Title
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.
Description
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
Title
MacArthur-Bates Communicative Development Inventory (MCDI) (Child)
Description
Parent report of child's expressive vocabulary and prelinguistic communication skills
Time Frame
Two months after the start of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan Y Roberts, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Sharing baseline data with the National Database for Autism Research (NDAR) semi-annually.
Citations:
PubMed Identifier
25733749
Citation
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.
Results Reference
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Parent Language Intervention for Autism

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