Clinical trial NCT02632773: Parent Language Intervention for Autism
Official title: The Role of Parent Phenotype in Parent-Mediated Language Interventions for Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Keywords: Language Intervention
Parent-Mediated Intervention
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2015-12-17
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Parent Use of Language Support Strategies (Mother-child interaction)
timeFrame: Two months after the start of the study
Secondary outcomes:
measure: 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.
timeFrame: Two months after the start of the study
measure: MacArthur-Bates Communicative Development Inventory (MCDI) (Child)
timeFrame: Two months after the start of the study
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Megan Y Roberts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.