NCT02632773

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

July 16, 2021

Status Verified

July 1, 2021

Enrollment Period

4.6 years

First QC Date

December 8, 2015

Last Update Submit

July 15, 2021

Conditions

Keywords

Language InterventionParent-Mediated Intervention

Outcome Measures

Primary Outcomes (1)

  • 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.

    Two months after the start of the study

Secondary Outcomes (2)

  • 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.

    Two months after the start of the study

  • MacArthur-Bates Communicative Development Inventory (MCDI) (Child)

    Two months after the start of the study

Study Arms (4)

Parent Learning Style 1

EXPERIMENTAL

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

Behavioral: Responsive Intervention

Parent Learning Style 2

EXPERIMENTAL

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

Behavioral: Responsive Intervention

Learning Style 1 (Parent)

OTHER

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

Behavioral: Directive Intervention

Learning Style 2 (Parent)

OTHER

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

Behavioral: Directive Intervention

Interventions

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.

Parent Learning Style 1Parent Learning Style 2

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 1 (Parent)Learning Style 2 (Parent)

Eligibility Criteria

Age18 Months - 48 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • \- Mother

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Evanston, Illinois, 60208, United States

Location

Related Publications (2)

  • 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.

    PMID: 25733749BACKGROUND
  • Fipp-Rosenfield HL, Levy RS, Grauzer JM, Kaat A, Roberts MY. Autistic Children's Irritability During Social Communication Assessments. Am J Speech Lang Pathol. 2024 Jan 3;33(1):369-377. doi: 10.1044/2023_AJSLP-23-00216. Epub 2023 Nov 27.

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Megan Y Roberts, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jane Steiner Hoffman and Michael Hoffman Assistant Professor of Communication Sciences and Disorders

Study Record Dates

First Submitted

December 8, 2015

First Posted

December 17, 2015

Study Start

August 1, 2015

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

July 16, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

Sharing baseline data with the National Database for Autism Research (NDAR) semi-annually.

Locations