Autism Spectrum DisorderNCT01179841
Intervention for Toddlers at Risk for Autism Spectrum Disorders (ASD)
A study testing Playgroup and Parent Training in people with Autism Spectrum Disorder, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 21 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Playgroup and Parent Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 21 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kennedy Krieger Institute
Baltimore, Maryland, 21211
About this study
Official title: A Comprehensive Approach to Intervention for Toddlers at Risk for ASD
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Playgroup, Parent Training
- Keywords
- Autism Spectrum Disorder, language, social, toddlers
- Medical subject headings
- Autism Spectrum Disorder, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaygroupBehavioural
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.
Parent TrainingBehavioural
Also called 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.
Parent TrainingBehavioural
Also called Individual 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.
| Study group | Role | What they receive |
|---|---|---|
| Playgroup and Parent Training | Experimental | 1. One to two-hour individual therapeutic sessions with parent training in the home or clinic, 1x every week over six months;
2. parent training/enrichment once a week in our clinic for 20 sessions at 1-2 hours;
3. a playgroup session for 1-2 hours 2x week for 6 months in our clinic and
4. Community treatment as usual. Receives: Behavioral: Playgroup; Behavioral: Parent Training |
| Parent Training | Active comparator | 1. Parent enrichment sessions once a week for 20 sessions (for 1-2 hours)
2. Community treatment as usual. Receives: Behavioral: Parent Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developmental Level
Using the Mullen Scales of Early Learning to assess.
Measured: 3 months into treatment, 6 months into treatment, and 6 months after treatment ends
Secondary outcomes (6)
Communication
Using Communication and Symbolic Behavior Scales to assess.
Measured: 3 months after treatment starts
Communication
Using Communication and Symbolic Behavior Scales to assess.
Measured: 6 months into treatment
Communication
Using Communication and Symbolic Behavior Scales to assess.
Measured: 6 months after treatment ends
Presence and Severity of Autism
Using Autism Diagnostic Observation Schedule to assess.
Measured: 3 months after treatment starts
Presence and Severity of Autism
Using Autism Diagnostic Observation Schedule to assess.
Measured: 6 months into treatment
Presence and Severity of Autism
Using Autism Diagnostic Observation Schedule to assess.
Measured: 6 months after treatment ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startJan 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Autism Speaks
- Responsible party
- Principal investigator, Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Rebecca Landa, PhD, CCC-SLP, Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179841
- Sponsor's protocol ID
- NA_00006553
- Status last verified
- Mar 2021
- First submitted
- 21 Jul 2010
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1177/1362361307070901.
PubMed 17175574Solomon 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.
PubMed 17478575Howlin 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.
PubMed 17501728
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Approach to Intervention for Toddlers at Risk for ASD
- ClinicalTrials.gov ID
- NCT01179841
- Acronym / sponsor ID
- NA_00006553
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, language, social, toddlers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Collaborators
- Autism Speaks
- Study start
- Jan 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Playgroup and Parent Training | Experimental | Behavioral: Playgroup, Behavioral: Parent Training1. One to two-hour individual therapeutic sessions with parent training in the home or clinic, 1x every week over six months; 2. parent training/enrichment once a week in our clinic for 20 sessions at 1-2 hours; 3. a playgroup session for 1-2 hours 2x week for 6 months in our clinic and 4. Community treatment as usual. |
| Parent Training | Active comparator | Behavioral: Parent Training1. Parent enrichment sessions once a week for 20 sessions (for 1-2 hours) 2. Community treatment as usual. |
Who may qualify
- Ages
- 11 to 21 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaygroupThe 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. | Behavioural | Playgroup and Parent Training |
| Parent TrainingAlso: Enrichment SessionsThe 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. | Behavioural | Parent Training, Playgroup and Parent Training |
| Parent TrainingAlso: Individual Therapeutic SessionsIn 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. | Behavioural | Playgroup and Parent Training |
Primary outcome
Developmental Level
Time frame: 3 months into treatment, 6 months into treatment, and 6 months after treatment ends
Using the Mullen Scales of Early Learning to assess.
6 secondary outcomes
Communication
Time frame: 3 months after treatment starts
Communication
Time frame: 6 months into treatment
Communication
Time frame: 6 months after treatment ends
Presence and Severity of Autism
Time frame: 3 months after treatment starts
Presence and Severity of Autism
Time frame: 6 months into treatment
Presence and Severity of Autism
Time frame: 6 months after treatment ends
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Background: PubMed 17175574Keen 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.
- Background: PubMed 17478575Solomon 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.
- Background: PubMed 17501728Howlin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Landa, PhD, CCC-SLP principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Playgroup and Parent Training in people with Autism Spectrum Disorder, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developmental Level (time frame: 3 months into treatment, 6 months into treatment, and 6 months after treatment ends). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01179841, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.