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Intervention for Toddlers at Risk for Autism Spectrum Disorders (ASD)

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Playgroup
Parent Training
Parent Training
Sponsored by
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, language, social, toddlers

Eligibility Criteria

11 Months - 21 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children will be ascertained between 11 months and 21 months of age
  • Must be able to enter the study prior to their second birthday
  • Must then pass an eligibility assessment to determine whether the child meets criteria for ASD and thus qualifies for the study. This assessment will consist of the Baby ADOS and the Mullen Scales of Early Learning. Children must meet criteria for ASD or autism on the ADOS, score more than one standard deviation below the mean on the Receptive or Expressive Language scale of the MSEL, and have a clinical judgment of ASD to be eligible for enrollment into treatment.
  • Parents must agree to participate in the study and commit to having their child participate in the intervention to which they are randomized for 6 months
  • The parent (or other primary caregiver, such as grandparent) in the Parent Enrichment/Training condition must agree to attend the training sessions

Exclusion Criteria:

  • Fail hearing or vision screening (by pediatrician's office, audiologist, or ophthalmologist)
  • Family's first language being other than English (language measures are normed on English speakers, putting non-English speakers at a disadvantage. In addition, the treatment is delivered in English. Children from non-English speaking homes may not make progress, but for reasons other than the efficacy of the intervention.)
  • Head injury (because this may cause some of the symptoms, which may not be due to autism and therefore we would not be able to assess the effects of the intervention on autism)
  • Identified reason for the autism (e.g., fragile X syndrome, Rett syndrome, Tuberous Sclerosis)
  • Inability of the family to attend the playgroup sessions and parent trainings
  • Parents whose hearing or vision is not within normal limits after correction (e.g., hearing aid, glasses)
  • Parents with developmental delays, language or learning impairments, or a psychiatric diagnosis IF the impairment would interfere with parent training (PI will assess on a case by case basis by talking to the parent)
  • Foster children
  • Refusal to allow videotaping of the children's assessments or intervention or to allow videotaped footage to be used for teaching purposes.

Sites / Locations

  • Kennedy Krieger Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Playgroup and Parent Training

Parent Training

Arm Description

One to two-hour individual therapeutic sessions with parent training in the home or clinic, 1x every week over six months; parent training/enrichment once a week in our clinic for 20 sessions at 1-2 hours; a playgroup session for 1-2 hours 2x week for 6 months in our clinic and Community treatment as usual.

Parent enrichment sessions once a week for 20 sessions (for 1-2 hours) Community treatment as usual.

Outcomes

Primary Outcome Measures

Developmental Level
Using the Mullen Scales of Early Learning to assess.

Secondary Outcome Measures

Communication
Using Communication and Symbolic Behavior Scales to assess.
Communication
Using Communication and Symbolic Behavior Scales to assess.
Communication
Using Communication and Symbolic Behavior Scales to assess.
Presence and Severity of Autism
Using Autism Diagnostic Observation Schedule to assess.
Presence and Severity of Autism
Using Autism Diagnostic Observation Schedule to assess.
Presence and Severity of Autism
Using Autism Diagnostic Observation Schedule to assess.

Full Information

First Posted
July 21, 2010
Last Updated
March 9, 2021
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
Autism Speaks
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1. Study Identification

Unique Protocol Identification Number
NCT01179841
Brief Title
Intervention for Toddlers at Risk for Autism Spectrum Disorders (ASD)
Official Title
A Comprehensive Approach to Intervention for Toddlers at Risk for ASD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
Autism Speaks

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This research is being done to test the effectiveness of an early intervention model for very young children at high risk for autism spectrum disorders (ASD) and their families. If children show improvement in this intervention, the investigators hope that the availability of public services of this type will be increased. Children between 11 months and 21 months old with Autism Spectrum Disorders, or with social and communication delays that indicate high risk for Autism Spectrum Disorders, and their parents may join the study. Treatment must start prior to the second birthday.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism Spectrum Disorder, language, social, toddlers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Playgroup and Parent Training
Arm Type
Experimental
Arm Description
One to two-hour individual therapeutic sessions with parent training in the home or clinic, 1x every week over six months; parent training/enrichment once a week in our clinic for 20 sessions at 1-2 hours; a playgroup session for 1-2 hours 2x week for 6 months in our clinic and Community treatment as usual.
Arm Title
Parent Training
Arm Type
Active Comparator
Arm Description
Parent enrichment sessions once a week for 20 sessions (for 1-2 hours) Community treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
Playgroup
Intervention Description
The playgroup will be conducted at our center and focuses on providing an invigorating learning environment in which emerging skills/knowledge are skillfully brought to a higher level of maturity, integrated with existing abilities, and used functionally. Learning with and through peers, provides the opportunity to address abnormal peer relationships for developmental level. Providing an enriched environment with toys, structured learning, and opportunities for ongoing engagement we offer the children experiences that they would not otherwise have. Parent training sessions will focus on strategies aimed at improving child social engagement and communication. Parent education sessions will focus on topics related to autism, learning styles, interventions, and resources.
Intervention Type
Behavioral
Intervention Name(s)
Parent Training
Other Intervention Name(s)
Enrichment Sessions
Intervention Description
The 1-2 hour individual therapeutic sessions with parent training in the home or clinic (1x every week over six months) are based on our own program which is in development. This program focuses on teaching parents how to encourage social and communication skills in their toddlers and also provides comprehensive information about development. Sessions will focus on knowledge of autism, current access to services, general knowledge of strategies used to facilitate child development, advocacy, knowledge of how to access services, and coping strategies.
Intervention Type
Behavioral
Intervention Name(s)
Parent Training
Other Intervention Name(s)
Individual Therapeutic Sessions
Intervention Description
In the once-a-week 1 to 2 hour parent training/enrichment, we will ask parents to target specific play and care routines in which they may stimulate their child's development in the ways identified by the therapist. These stimulation times may be provided by the parents, other family members, friends, volunteers or hired assistants. Parents will be encouraged to have their child in direct skill-enhancing engagement for 1-2 hour per day. The therapist will work with the family to identify times during the day that best lend themselves to accomplishing this goal.
Primary Outcome Measure Information:
Title
Developmental Level
Description
Using the Mullen Scales of Early Learning to assess.
Time Frame
3 months into treatment, 6 months into treatment, and 6 months after treatment ends
Secondary Outcome Measure Information:
Title
Communication
Description
Using Communication and Symbolic Behavior Scales to assess.
Time Frame
3 months after treatment starts
Title
Communication
Description
Using Communication and Symbolic Behavior Scales to assess.
Time Frame
6 months into treatment
Title
Communication
Description
Using Communication and Symbolic Behavior Scales to assess.
Time Frame
6 months after treatment ends
Title
Presence and Severity of Autism
Description
Using Autism Diagnostic Observation Schedule to assess.
Time Frame
3 months after treatment starts
Title
Presence and Severity of Autism
Description
Using Autism Diagnostic Observation Schedule to assess.
Time Frame
6 months into treatment
Title
Presence and Severity of Autism
Description
Using Autism Diagnostic Observation Schedule to assess.
Time Frame
6 months after treatment ends

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Months
Maximum Age & Unit of Time
21 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children will be ascertained between 11 months and 21 months of age Must be able to enter the study prior to their second birthday Must then pass an eligibility assessment to determine whether the child meets criteria for ASD and thus qualifies for the study. This assessment will consist of the Baby ADOS and the Mullen Scales of Early Learning. Children must meet criteria for ASD or autism on the ADOS, score more than one standard deviation below the mean on the Receptive or Expressive Language scale of the MSEL, and have a clinical judgment of ASD to be eligible for enrollment into treatment. Parents must agree to participate in the study and commit to having their child participate in the intervention to which they are randomized for 6 months The parent (or other primary caregiver, such as grandparent) in the Parent Enrichment/Training condition must agree to attend the training sessions Exclusion Criteria: Fail hearing or vision screening (by pediatrician's office, audiologist, or ophthalmologist) Family's first language being other than English (language measures are normed on English speakers, putting non-English speakers at a disadvantage. In addition, the treatment is delivered in English. Children from non-English speaking homes may not make progress, but for reasons other than the efficacy of the intervention.) Head injury (because this may cause some of the symptoms, which may not be due to autism and therefore we would not be able to assess the effects of the intervention on autism) Identified reason for the autism (e.g., fragile X syndrome, Rett syndrome, Tuberous Sclerosis) Inability of the family to attend the playgroup sessions and parent trainings Parents whose hearing or vision is not within normal limits after correction (e.g., hearing aid, glasses) Parents with developmental delays, language or learning impairments, or a psychiatric diagnosis IF the impairment would interfere with parent training (PI will assess on a case by case basis by talking to the parent) Foster children Refusal to allow videotaping of the children's assessments or intervention or to allow videotaped footage to be used for teaching purposes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Landa, PhD, CCC-SLP
Organizational Affiliation
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21211
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17175574
Citation
Keen D, Rodger S, Doussin K, Braithwaite M. A pilot study of the effects of a social-pragmatic intervention on the communication and symbolic play of children with autism. Autism. 2007 Jan;11(1):63-71. doi: 10.1177/1362361307070901.
Results Reference
background
PubMed Identifier
17478575
Citation
Solomon R, Necheles J, Ferch C, Bruckman D. Pilot study of a parent training program for young children with autism: the PLAY Project Home Consultation program. Autism. 2007 May;11(3):205-24. doi: 10.1177/1362361307076842.
Results Reference
background
PubMed Identifier
17501728
Citation
Howlin P, Gordon RK, Pasco G, Wade A, Charman T. The effectiveness of Picture Exchange Communication System (PECS) training for teachers of children with autism: a pragmatic, group randomised controlled trial. J Child Psychol Psychiatry. 2007 May;48(5):473-81. doi: 10.1111/j.1469-7610.2006.01707.x.
Results Reference
background

Learn more about this trial

Intervention for Toddlers at Risk for Autism Spectrum Disorders (ASD)

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