AutismNCT02632773
Parent Language Intervention for Autism
A study testing Responsive Intervention and Directive Intervention in people with Autism, run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism
- What is being tested?
- Responsive Intervention and Directive Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism
- Being tested
- Responsive Intervention, Directive Intervention
- Keywords
- Language Intervention, Parent-Mediated Intervention
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Responsive InterventionBehavioural
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.
Directive InterventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| Parent Learning Style 1 | Experimental | Mothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Directive Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
20 minute video of a therapist-child interaction in the clinic with a standard set of age-appropriate toys.
Measured: Two months after the start of the study
MacArthur-Bates Communicative Development Inventory (MCDI) (Child)
Parent report of child's expressive vocabulary and prelinguistic communication skills
Measured: Two months after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Megan Roberts, Northwestern University
- Investigators
- Megan Y Roberts, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632773
- Sponsor's protocol ID
- 1R01DC014709-01
- Other IDs
- 1R01DC014709-01
- Status last verified
- Jul 2021
- First submitted
- 8 Dec 2015
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Sharing baseline data with the National Database for Autism Research (NDAR) semi-annually.
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.
PubMed 25733749Fipp-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.
PubMed 38010261
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Parent Phenotype in Parent-Mediated Language Interventions for Autism
- ClinicalTrials.gov ID
- NCT02632773
- Acronym / sponsor ID
- 1R01DC014709-01
- Conditions
- Autism
- Keywords
- Language Intervention, Parent-Mediated Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Aug 2015 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Parent Learning Style 1 | Experimental | Behavioral: Responsive InterventionMothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group. |
| Parent Learning Style 2 | Experimental | Behavioral: Responsive InterventionMothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group. |
| Learning Style 1 (Parent) | Other | Behavioral: Directive InterventionMothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group. |
| Learning Style 2 (Parent) | Other | Behavioral: Directive InterventionMothers with Learning Style 2 will be randomly assigned to either the responsive intervention or directive intervention group. |
Who may qualify
- Ages
- 18 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Responsive InterventionMothers 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. | Behavioural | Parent Learning Style 1, Parent Learning Style 2 |
| Directive InterventionMothers 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. | Behavioural | Learning Style 1 (Parent), Learning Style 2 (Parent) |
Primary outcome
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.
2 secondary outcomes
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
MacArthur-Bates Communicative Development Inventory (MCDI) (Child)
Time frame: Two months after the start of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Background: PubMed 25733749Roberts 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.
- Derived from this study: PubMed 38010261Fipp-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.
- Individual participant dataSharing planned: Yes. Sharing baseline data with the National Database for Autism Research (NDAR) semi-annually.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Y Roberts, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Responsive Intervention and Directive Intervention in people with Autism, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Use of Language Support Strategies (Mother-child interaction) (time frame: Two months after the start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02632773, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.