Phenotypic Specific Communication Intervention for Children With Down Syndrome
Condition: Language Impairment; Down Syndrome
MeSH terms: Down Syndrome; Language Disorders; Syndrome
Study type: Interventional

Summary: 
      Children with Down syndrome (DS) have greater difficulty acquiring expressive language than
      is predicted by their general cognitive abilities and language comprehension (Miller, 1999).
      To date, interventions to improve communication outcomes for children with DS have met with
      only modest success. The proposed study is a randomized controlled trial of an early
      communication intervention combining two evidence-based treatments that teach expressive
      communication (Enhanced Milieu Teaching; EMT) and joint attention/symbolic play (Joint
      Attention Symbolic Play Engagement and Regulation; JASPER) using a dual mode (words +AAC).
      The intervention (a) teaches the foundations of communication (joint attention, play), (b)
      builds on positive child characteristics of social attention, (c) uses naturalistic
      strategies to increase the rate and complexity of communication and increase task engagement,
      (d) addresses the potential value of adding visual support (AAC) to spoken communication, and
      (e) includes parents as implementers of the intervention to promote generalization across
      settings and activities, and to ensure maintenance over time. It is hypothesized that
      children with DS enrolled in the intervention will have better language and communication
      skills at the end of treatment and followup than children in the BAU comparison group.The
      study will enroll 82 30 to 54 month old children with DS who have fewer than 20 words.
      Examining predictors of response to treatment and the effects of treatment on executive
      functioning will inform both theory and practice.
    

Detailed description: 
      This is a two-site randomized controlled trial (RCT) of the efficacy of JASP-EMT, an
      innovative blended communication intervention, JASPER (joint engagement and play
      intervention), and EMT (Enhanced Milieu Teaching). The study evaluates the relative benefits
      of teaching young children with DS using dual communication modes: spoken words with AAC.
      JASP-EMT involves direct intervention with children as well as parent training in an attempt
      to increase generalization of intervention effects. A control group will receive community
      treatment as usual (BAU). Participants include 82 children with DS ages 30 to 54 months
      across two sites.

      AIM 1: To examine the effects of an experimental intervention (Words + AAC) on primary
      (expressive language) and secondary outcomes (receptive language, symbolic play,
      symbol-infused joint engagement, and parent use of language support strategies).

      H1: Children in the Words+AAC group will have significantly better primary and secondary
      outcomes than children in the control group.

      H2: Parents of children in Words+AAC group will demonstrate increased use of language support
      strategies than parents of children in the control group.

      AIM 2: To examine maintenance and generalization of the effects of the experimental
      interventions on children and their parents.

      H3: Intervention effects will maintain at follow-up and generalize across contexts.

      AIM 3 (exploratory): To examine the effect of potential child level moderators on the primary
      and secondary outcomes of the study.

      H4: Child characteristics at baseline (e.g., speech intelligibility, cognitive level) will
      moderate primary child outcomes.

      AIM 4 (exploratory): To examine the effect of the experimental intervention on executive
      functioning.

      H5: Children in the Words+AAC group will demonstrate improved executive functioning following
      intervention relative to the children in the control group.

      Participants

      A total of 82 children and their parents will be recruited to the study (41 at Vanderbilt and
      41 at UCLA). Child MA of 18 months ensures children have the cognitive skills for symbolic
      representation in communication. The sample is expected to be 40% minority with equal numbers
      of males and females. Most parents are expected to be lower to upper middle class mothers.

      Summary of Intervention

      The goal of the intervention is to help children with DS develop expressive language skills
      that will improve participation in social, academic and community environments. Children will
      receive direct intervention from a therapist; additionally, parents will be taught to use the
      Words + AAC strategies in the clinic and at home across routines. Therapists use all
      strategies throughout the intervention; parents learn strategies sequentially.

      Length of Intervention: 4/week for 4 months (48 sessions); 40 minute clinic sessions, 60
      minute home sessions Type of Intervention sessions: 6 workshops, 18 clinic training sessions,
      24 home training sessions Mode: AAC (iPad) and verbal input and output Maintenance: every six
      weeks for 6 months after completion of the intervention
    

Intervention name(s): Jasper-EMT with words and AAC
Intervention type(s): Behavioral
Intervention description(s): Jasper-EMT with words and AAC
A therapist plus parent implemented social communication intervention which include use of the iPad for a mode of communication. A total of 6 hour long workshops with the parent and 42 hour long intervention sessions with the child occur; half include the parent as therapist and occur in the home. The treatment lasts approximately 4 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Down syndrome; Language intervention; Communication intervention