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Completed

NCT Number: NCT02632773

Parent Language Intervention 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.

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Key information

Age range

18 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Evanston, Illinois, 60208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Responsive Intervention

Behavioral

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 Intervention

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

The Role of Parent Phenotype in Parent-Mediated Language Interventions for Autism

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Dec 17, 2015
Registry last updated
Jul 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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