Down Syndrome Clinical Trial
Official title:
Phenotypic Specific Communication Intervention for Children With Down Syndrome
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.
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
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04854122 -
Blood Flow Regulation in Individuals With Down Syndrome - Training Study
|
N/A | |
| Completed |
NCT04020302 -
Self-Monitoring Shopping Intervention
|
N/A | |
| Recruiting |
NCT01950624 -
DS-Connect {TM}: The Down Syndrome Registry
|
||
| Completed |
NCT04751136 -
the Effect of Cerebrolysin on Physical and Mental Functions of Down Syndrome
|
Phase 2 | |
| Completed |
NCT04767412 -
Inspiratory Muscle Training and Physical Fitness in Children With Down Syndrome Randomized Control Trial
|
N/A | |
| Completed |
NCT04536506 -
Bobath and Vojta Therapy for DS
|
N/A | |
| Not yet recruiting |
NCT04037579 -
Protocol for a Non-randomized Survey in Down Syndrome People Who Practice Sports. Self and Observers´ Perception.
|
||
| Completed |
NCT02882698 -
Performance Analysis in Down Syndrome on Mobile Phone
|
N/A | |
| Completed |
NCT01791725 -
A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia
|
Phase 2 | |
| Unknown status |
NCT01975545 -
Fluor Varnish With Silver Nanoparticles for Dental Remineralization in Patients With Trisomy 21
|
Phase 2 | |
| Completed |
NCT01808508 -
Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome
|
N/A | |
| Terminated |
NCT00754013 -
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10
|
Phase 3 | |
| Terminated |
NCT00754052 -
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17
|
Phase 3 | |
| Completed |
NCT01313325 -
Hippotherapy to Improve the Balance of Children With Movement Disorders
|
N/A | |
| Completed |
NCT01256112 -
Parent Supported Weight Reduction in Down Syndrome
|
N/A | |
| Completed |
NCT01594346 -
Multicenter Vitamin E Trial in Aging Persons With Down Syndrome
|
Phase 3 | |
| Completed |
NCT05343468 -
Life Skills Improved in Children With Down Syndrome After Using Assistive Technology
|
N/A | |
| Suspended |
NCT05755464 -
Evaluation of Patients With Down Syndrome Compliance to Dental Therapy
|
||
| Recruiting |
NCT04022460 -
Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)
|
||
| Completed |
NCT04818437 -
Effect of Core Stability Exercises and Balance Training in Postural Control Among Down Syndrome
|
N/A |