Merck: Phenotypic Specific Communication Intervention for Children With Down Syndrome

Sponsor

Vanderbilt University (Other)

Overall Status

Completed

CT.gov ID

NCT02158390

Collaborator

University of California, Los Angeles (Other)

Enrollment

Locations

Arms

44.2

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Language Impairment Down Syndrome	Behavioral: Jasper-EMT with words and AAC	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Phenotypic Specific Communication Intervention for Children With Down Syndrome

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Aug 30, 2017

Actual Study Completion Date :

Feb 6, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Jasper-EMT with words and AAC 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.	Behavioral: Jasper-EMT with words and AAC 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.
No Intervention: Community treatment as usual Children access educational and speech-language interventions available to them through schools and community resources.

Arm

Intervention/Treatment

Experimental: Jasper-EMT with words and AAC

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.

Behavioral: Jasper-EMT with words and AAC

No Intervention: Community treatment as usual

Children access educational and speech-language interventions available to them through schools and community resources.

Outcome Measures

Primary Outcome Measures

Spoken language [up to 3 months]
Spoken language is measured by transcribing child utterances ( spoken and AAC generated ) during 20 minute naturalistic language samples. Linguistic analysis are automated, via SALT.

Secondary Outcome Measures

Receptive language [up to 3 months]
Receptive language is assessed by child performance on the Preschool Language Scale 5th Edition ( PLS-5), a standardized language assessment.
Executive Functioning [up to 3 months]
Children's executive functioning abilities will be assessed across a variety of tasks measuring persistence, planning, and attention.

Other Outcome Measures

Parent use of Joint Attention Symbolic Play Engagement and Regulation- Enhanced Milieu Teaching ( Jasper-EMT) strategies [up to 3 months]
Observations of parent-child interactions are coded to determine parent use of key intervention strategies.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Months to 54 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Diagnosis of DS from medical records.
Mental age (MA) of 18 months as measured on the Visual Reception subtest of the Mullen Scales of Early Learning.
Expressive vocabulary of fewer than 20 words at measured on a naturalistic language sample.
Age between 30 and 54 months
English or Spanish as the primary language at home.
Parents who are willing to participate in parent training.

Exclusion Criteria:

Major medical conditions other than DS, specifically (a) developmental disorders (e.g. autism); (b) sensory disabilities (e.g. blindness/deafness), and (c) motor disabilities not related to DS, (e.g. cerebral palsy)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles Center for Autism Research and Treatment	Los Angeles	California	United States	90024
2	Vanderbilt University Kennedy Center	Nashville	Tennessee	United States	37203