Intervention for Toddlers at Risk for Autism Spectrum Disorders (ASD) - Full Text View

Sponsor:	Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborator:	Autism Speaks
Information provided by (Responsible Party):	Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:	NCT01179841

Purpose

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.

Condition	Intervention
Autism Spectrum Disorder	Behavioral: Playgroup Behavioral: Parent Training/Enrichment Sessions Behavioral: Individual Parent Therapeutic Sessions

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Comprehensive Approach to Intervention for Toddlers at Risk for ASD

Resource links provided by NLM:

MedlinePlus related topics: Autism

U.S. FDA Resources

Further study details as provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:

Primary Outcome Measures:

Developmental Level [ Time Frame: 3 months after treatment starts ] [ Designated as safety issue: No ]
Will be using the Mullen Scales of Early Learning to assess.
Developmental Level [ Time Frame: 6 months into treatment ] [ Designated as safety issue: No ]
Will be using the Mullen Scales of Early Learning to assess.
Developmental Level [ Time Frame: 6 months after treatment ends ] [ Designated as safety issue: No ]
Will be using the Mullen Scales of Early Learning to assess.

Secondary Outcome Measures:

Communication [ Time Frame: 3 months after treatment starts ] [ Designated as safety issue: No ]
Using Communication and Symbolic Behavior Scales to assess.
Communication [ Time Frame: 6 months into treatment ] [ Designated as safety issue: No ]
Using Communication and Symbolic Behavior Scales to assess.
Communication [ Time Frame: 6 months after treatment ends ] [ Designated as safety issue: No ]
Using Communication and Symbolic Behavior Scales to assess.
Presence and Severity of Autism [ Time Frame: 3 months after treatment starts ] [ Designated as safety issue: No ]
Using Autism Diagnostic Observation Schedule to assess.
Presence and Severity of Autism [ Time Frame: 6 months into treatment ] [ Designated as safety issue: No ]
Using Autism Diagnostic Observation Schedule to assess.
Presence and Severity of Autism [ Time Frame: 6 months after treatment ends ] [ Designated as safety issue: No ]
Using Autism Diagnostic Observation Schedule to assess.

Estimated Enrollment:	60
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Playgroup and Parent Training 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.	Behavioral: Playgroup 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. Behavioral: Parent Training/Enrichment Sessions 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. Behavioral: Individual Parent Therapeutic Sessions 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.
Experimental: Parent Training will only receive parent training/enrichment 1x week for 20 sessions (for 1-2 hours) in addition to community treatment as usual.	Behavioral: Parent Training/Enrichment Sessions 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.

Arms

Assigned Interventions

Experimental: Playgroup and Parent Training

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.

Behavioral: Playgroup

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.

Behavioral: Parent Training/Enrichment Sessions

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.

Behavioral: Individual Parent Therapeutic Sessions

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.

Experimental: Parent Training

will only receive parent training/enrichment 1x week for 20 sessions (for 1-2 hours) in addition to community treatment as usual.

Behavioral: Parent Training/Enrichment Sessions

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.

Eligibility

Ages Eligible for Study:	11 Months to 21 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179841

Contacts

Contact: Rebecca Landa, PhD, CCC-SLP	443-923-7680	landa@kennedykrieger.org
Contact: Jennifer Sharpless, MS	443-923-7572	sharpless@kennedykrieger.org

Locations

United States, Maryland
Kennedy Krieger Institute	Recruiting
Baltimore, Maryland, United States, 21211
Contact: Rebecca Landa, PhD, CCC-SLP 443-923-7551 landa@kennedykrieger.org
Contact: Jennifer Sharpless, MS 443-923-7572 sharpless@kennedykrieger.org
Principal Investigator: Rebecca Landa, PhD, CCC-SLP

Sponsors and Collaborators

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Autism Speaks

Investigators

Principal Investigator:

Rebecca Landa, PhD, CCC-SLP

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

More Information

Publications:

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.

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.

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.

Responsible Party:	Rebecca Landa, Principal Investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:	NCT01179841 History of Changes
Other Study ID Numbers:	NA_00006553
Study First Received:	July 21, 2010
Last Updated:	August 29, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:

Autism Spectrum Disorder
language
social
toddlers

Additional relevant MeSH terms:

Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012