JASPER Intervention in Down Syndrome
- Conditions
- Down Syndrome, Trisomy 21
- Interventions
- Behavioral: JASPER
- Registration Number
- NCT03653143
- Lead Sponsor
- Boston Children's Hospital
- Brief Summary
The goal of this study is to determine whether JASPER (Joint Attention, Symbolic Play, Engagement, Regulation), which is an intensive, targeted early behavioral intervention focused on a developmentally based approach for teaching joint engagement, joint attention, and play skills can improve behavioral / emotional regulation, social communication skills, and developmental trajectories in Down syndrome (DS). The investigators will also explore the potential use of EEG and event-related potentials (ERP) as outcome measures, as this approach may help elucidate mechanisms of change in behavior and development, and may help explain differences in development of social communication skills in individuals with DS. EEG and ERP measure may also help to predict treatment outcome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- Confirmed diagnosis of Trisomy 21
- Age 24-48 months
- Able to walk independently across a room
- Uses at least 5 words / signs
- English speaking
- Parent able to accompany participant to all study visits
-Diagnosis of Mosaic / Translocation Down syndrome
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment Group JASPER Assessment #1 Baseline Visit \>\> 3 month JASPER intervention (weekly) \>\> Assessment #2 Research Visit \>\> 3 month treatment as usual \>\> Assessment #3 Research Visit Control/Wait-list Group JASPER Assessment #1 Baseline Visit \>\> 3 month treatment as usual \>\> Assessment #2 Research Visit \>\> 3 month JASPER intervention \>\> Assessment #3 Research Visit
- Primary Outcome Measures
Name Time Method Change in Joint Engagement Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months) Joint engagement will be measured by coded videos of the Caregiver Child Interaction (CCX) session. CCX measures the amount of time that parent and child engage during a play session.
- Secondary Outcome Measures
Name Time Method Change in joint attention skills Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months) The Caregiver Child Interaction sessions (CCX) and Early Social Communication Scales (ESCS) or Pictorial Infant Communication Scale (PICS) will be used to measure changes in joint attention skills. ESCS, which will only be used for in-person participation, uses tasks to measure the frequency of the child's initiation and response (see above). The PICS will replace the ESCS for virtual participation. The PICS uses photographs to aid caregivers in understanding and identifying the specific behaviors of interest. Modeled after the ESCS, the PICS assesses various forms and functions of triadic attention in young children. The CCX, which will be used for in-person and virtual participation, measures the amount of time that parent and child engage during a play session.
Change in social-communication skills (part a) Administered at baseline assessment #1 (0 months) and assessment visit #3 (6 months) Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) will be used to measure social communication skills for in-person participation. ADOS-2 subscales include areas like 1) Language and communication and 2) Reciprocal social interaction. Items within each subscale are scored on unique ranges starting with 0=closest to mastery of behavior.
The Autism Diagnostic Interview - Revised (ADI-R) will replace the ADOS for virtual participation. The ADI-R is a comprehensive parent interview that focuses on three functional domains of behavior that are not typically present in individuals without autism spectrum disorder. The three domains are: Language/Communication, Reciprocal Social Interactions, and Restricted, Repetitive, and Stereotyped Behaviors and Interests.Change in language, socialization, problem behavior, adaptive skills (part a) Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months) Subscales of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) will be used to measure language, socialization, problem behaviors and adaptive skills. VABS-II subscales include 1) Communication 2) Daily living skills 3) Socialization, and 4) Motor skills. Behavior frequency is measured on a range of 0=Never to 1=Sometimes to 2=Usually.
Change in social-communication skills (part b) Administered at baseline assessment #1 (0 months) and assessment visit #3 (6 months) The Early Social Communication Scales (ESCS) is an experimental measurement that measures change in social-communication skills. It will be used for in-person participation only. The ESCS uses tasks to measure the frequency of initiation of and response to 1) Joint attention 2) Behavioral requests, and 3) Social interaction.
The PICS will replace the ESCS for virtual participation. The PICS uses photographs to aid caregivers in understanding and identifying the specific behaviors of interest. Modeled after the ESCS, the PICS assesses various forms and functions of triadic attention in young children.Change in cognition Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months) For in-person participation only, composite scores from the Mullen Scales of Early Learning (MSEL) will be used to measure cognition and language development. Composite scores are calculated averages based on MSEL subscales 1) Gross motor 2) Visual reception 3) Fine motor 4) Receptive language 5) Expressive language. Higher composite scores are associated with higher cognitive and language functioning.
Change in language, socialization, problem behavior, adaptive skills (part b) Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months) The Aberrant Behavior Checklist-Community (ABC-C) will also be used to measure language, socialization, problem behavior, and adaptive skills for in-person participation. ABC-C subscales include 1) Irritability 2) Lethargy 3) Stereotypy 4) Hyperactivity, and 5) Inappropriate speech and are measured on a range of 0=not at all a problem to 3=the problem is severe in degree.
The MacArthur-Bates Communicative Development Inventories (MB-CDI) will replace the ABC-C for virtual participation. The MB-CDI is a parent report instrument that captures important information about children's developing abilities in early language, including 1) Vocabulary comprehension 2) Production 3) Gestures, and 4) Grammar.Change in play levels Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months) Flexibility and diversity of play will be coded from the Structured Play Assessment (SPA) for in-person participation only. Different toys are presented to the child, and play interaction is measured in terms of 1) Functional play types 2) Symbolic play types, and 3) Play level.
Trial Locations
- Locations (1)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States