Delivering Early Intervention to Children With Down Syndrome
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|ClinicalTrials.gov Identifier: NCT03935620|
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : May 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Down Syndrome||Behavioral: Enhanced Milieu teaching||Not Applicable|
- Aim 1: To examine the effect of using a telemedicine service delivery model to teach parents of children with DS to use EMT language support strategies. The investigators hypothesize that parents will learn to use EMT language support strategies from the personalized instruction provided during 36 intervention sessions.
- Aim 2: To examine the effect of delivering EMT using a telemedicine service delivery model to improve the spoken language and social communication skills of children with DS. The investigators hypothesize that improvements in child communication and language skills will result from increasing parents' use of EMT language support strategies during everyday parent-child interactions such as play with toys, singing songs, book reading, and mealtimes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A single case multiple-baseline across behaviors (i.e., EMT strategies) design—replicated across ten caregiver-child dyads will be used to evaluate the effect of implementing EMT via telepractice on parent's EMT strategy usage and concomitant increases in child communication. Within each design there will be three potential demonstrations of effect and three potential replications across participants|
|Masking:||None (Open Label)|
|Official Title:||Delivering Early Intervention to Children With Down Syndrome Through Telemedicine|
|Estimated Study Start Date :||May 15, 2019|
|Estimated Primary Completion Date :||March 1, 2020|
|Estimated Study Completion Date :||September 1, 2021|
After a period of stable baseline performance (3 to 5 sessions) for parents and children the interventionists will apply the EMT Language Intervention.
Behavioral: Enhanced Milieu teaching
Enhanced Milieu Teaching (EMT) an evidence-based, naturalistic language intervention that has been optimized to address the specific language and communication deficits associated with DS. EMT is a parent-implemented intervention that involves home-visits during which clinicians teach parents to support their child learning language during typical parent-child interactions at home (play with toys, music, book reading, and snack time). Clinicians follow an evidence-based instructional framework called "Teach-Model-Coach-Review" to teach parents language support strategies.
- Between Session Change:Number of EMT Strategies Used by Parents During Parent-Child Interaction [ Time Frame: Assessed 1-2 times per week for 3- 4 months. ]Observational measure coded from video-recordings of a 15 minute caregiver-child interaction. 10 minutes of play and toys and 5 minutes of a home routine. Changes in the number of different EMT strategies used by parents will be quantified.
- Between Session Change: Rate of Symbolic Communication During Parent-Child Interaction [ Time Frame: Assessed 1-2 times per week for 3-4 months. ]Observational measure coded from video-recordings of a 15 minute caregiver-child interaction. 10 minutes of play and toys and 5 minutes of a home routine.
- Communication Matrix Scores [ Time Frame: Assessed at T00 (Study Entry) and T01 (3- 4 months post intervention). ]Total score on an assessment of early expressive communication skills.
- Between Session Change: Number of Different Words Expressed During Parent-Child Interaction [ Time Frame: Assessed 1-2 times per week for 3-4 months. ]Observational measure coded from video-recordings of a 15 minute caregiver-child interaction. 10 minutes of play and toys and 5 minutes of a home routine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935620
|Contact: Emily D Quinn, Ph.D.||503-494-2263 ext firstname.lastname@example.org|
|Contact: Emily D Quinn, Ph.D||5034942263 ext email@example.com|
|United States, Oregon|
|Oregon Health and Science University||Recruiting|
|Portland, Oregon, United States, 97236|
|Contact: Emily D Quinn 503-494-2263 ext 5034942263 firstname.lastname@example.org|
|Contact: Emily D Quinn 5034942263 ext 5034942263 email@example.com|
|Principal Investigator:||Emily D Quinn, Ph.D||Oregon Health and Science University|