NCT01614275

Brief Summary

The purpose of this study is to determine the extent to which technology may be used to provide (a) state-of-the-art assessment and intervention for children diagnosed with autism and (b) parent and tutor training for those who care for these children. Children with autism often have problems with social interaction, language, and repetitive behavior (e.g., hand flapping and body rocking). Without early and intensive treatments, the long-term outcomes for children with autism are not very good; therefore, it is very important that effective treatments are started as soon as possible. Research has shown that Early Intensive Behavioral Interventions (EIBI) is an effective treatment for autism. Although EIBI is effective, most children with autism in military families do not receive EIBI because there are few professionals and paraprofessionals that are appropriately trained to do this, especially in the remote areas where military families tend to serve. The investigators want to show that web-based technologies (e.g., web-cams and internet-protocol cameras) can be used so that professionals in one place can treat children with autism anywhere in the world. The investigators also expect that providing these services will help children with autism improve their language, social, and academic skills. The investigators expect that the gains made by the children will help relieve many daily stressors and worries that families with children with autism have. Children with autism who lack adaptive skills require constant help and supervision from parents. Thus, the improvements in the child's functioning will allow the child to become more independent and decrease parent stress associated with the need to constantly watch and help the child. Because EIBI services produce lasting improvements long after the intervention has ended, this project will provide both short-term and long-term benefits to the children who participate in the study, which will provide lasting relief to these dedicated military families. In the long-term, this project may really change the way in which all (military and non-military) children and families get effective services that they cannot get now. Also, the results may help other professionals and researchers in psychology and medicine. That is, the results should be helpful to any kind of service that uses parent training and paraprofessionals. Most importantly, these services will improve the overall functioning of the children with autism and decrease the overall stress on these families as they continue to serve our country.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

February 7, 2018

Status Verified

February 1, 2018

Enrollment Period

5.1 years

First QC Date

June 5, 2012

Last Update Submit

February 6, 2018

Conditions

Keywords

AutismEarly InterventionParent TrainingEIBIApplied Behavior Analysis

Outcome Measures

Primary Outcomes (1)

  • Intelligent Quotient: Differential Abilities Scales, Second Edition

    The investigators will use the Differential Abilities Scales, Second Edition (DAS-2; Elliott, 2007) as the primary dependent measure because it is particularly useful for measuring the cognitive abilities of young children; it covers a large age range (ages 2-6 to 17-11); it is well standardized; it has strong internal consistency and test-retest reliability (.90 to .95); and it correlates well with other measures of intelligence (M r = .76).

    Time-to-Event Outcome Measure: Prior to and following intervention services (approximately 8 months)

Secondary Outcomes (2)

  • Parent Training: Behavioral Implementation Skills for Play Activities

    Time-to-Event Outcome Measure: Prior to and following parent-training curriculum (6 to 8 weeks)

  • Tutor Training: Behavioral Implementation of Work Activities

    Time-to-Event Outcome Measure: Prior to and following tutor-training curriculum (9 to 12 weeks)

Study Arms (4)

Technology-enhanced Parent Training

EXPERIMENTAL

The investigators will demonstrate that web-based instructional technologies provides an efficient and effective mechanism for training military parents of children with autism, regardless of their geographic location, to implement effective behavior management and teaching strategies with high procedural integrity (90% accuracy).

Behavioral: Technology-Enhanced Parent Training

Technology-enhanced Tutor Training

EXPERIMENTAL

The investigators will demonstrate that web-based instructional technologies provides an efficient and effective mechanism for training tutors to implement early intervention services that are commonly used with children diagnosed with autism with high procedural integrity (above 80%).

Behavioral: Technology-Enhanced Tutor Training

Technology-enhanced Early Intensive Behavioral Intervention

EXPERIMENTAL

The investigators will demonstrate that technology-enhanced service delivery will provide remote access to efficient and effective EIBI services to military families affected by autism.

Behavioral: Technology-enhanced Early Intensive Behavioral Intervention

Wait-list No-intervention Control Group

PLACEBO COMPARATOR

Tutors and families will be assigned to treatment and control groups using the process of minimization, which has been recommended for small clinical trials because it minimizes differences between the groups on relevant covariables while guarding against bias in ways comparable to simple randomization. The control group will not receive intervention services.

Behavioral: No-Intervention

Interventions

The training for the parents of children with autism assigned to the EIBI group will begin with completion of a structured parent-training program for 6 weeks that includes 16 to 18 sessions (three, 90-minute sessions per week). When a new topic is introduced, the initial training will include viewing a Power Point presentation, with embedded video and audio, that explains, in laymen's terms, the basic principles and processes related to the topic. The second part of the training involves a parent recruiting an adult friend, who will play the role of a child with autism. The adult playing the child with autism will wear a Bluetooth earpiece connected to a computer, which in turn will be connected to a UNMC expert. The expert will guide the actions of the adult playing the role of the child such that this confederate "child" will exhibit a variety of target behaviors relevant to the target skill, which will provide an opportunity for immediate feedback.

Technology-enhanced Parent Training

The training for the tutors to work with children diagnosed with autism, who were assigned to the EIBI group, will complete a 40-hour structured training program for 4 to 8 weeks that includes approximately 32 sessions. When a new topic is introduced, the initial training will include viewing a PowerPoint presentation, with embedded video and audio, that explains, in laymen's terms, the basic principles and processes related to the topic. The second part of the training involves a tutor recruiting an adult friend, who will play the role of a child with autism. The adult playing the child with autism will wear a Bluetooth earpiece connected to a computer, which in turn will be connected to a UNMC expert. The expert will guide the actions of the adult playing the role of the child such that this confederate "child" will exhibit a variety of target behaviors relevant to the target skill, which will provide an opportunity for immediate feedback.

Technology-enhanced Tutor Training

After training, the ABA tutor and parents will assist in the implementation of early intervention services that will be tailored to the particular needs of the family's child. These programs could include conducting a paired-stimulus preference assessment, using a natural language program to increase spoken communication, and using matching-to-sample methods to teach categorization skills. We will record and review at least an hour of the ABA tutor's and parents' interactions with the child per week during unstructured and structured teaching situations. The purpose of these observations is to determine whether the parents are implementing the teaching strategies or behavior-management programs as designed (i.e., treatment integrity measures). If the ABA tutor or parent implements a program with less than 80% accuracy across two consecutive observations, an additional scripted role-play will be conducted as a booster session for the targeted skills.

Technology-enhanced Early Intensive Behavioral Intervention
No-InterventionBEHAVIORAL

The ABA tutors, parents/caregivers, and children will be randomly assigned to a wait-list control group.

Wait-list No-intervention Control Group

Eligibility Criteria

Age18 Months - 48 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • (a) chronological age between 18 and 48 months of age,
  • (b) nonverbal mental age greater than 12 months (which is necessary to make an accurate diagnosis of autism in young children), and
  • (c) diagnosis of autism confirmed by meeting the cut-off scores on the autism diagnostic interview-revised (ADI-R) and the autism diagnostic observation schedule (ADOS)
  • (a) age 19 or above;
  • (b) completion of, or enrollment in, an associate's or bachelor's degree program in psychology or a related field;
  • (c) completion of at least 12 semester credit hours at an accredited college or university;
  • (d) passage of criminal and abuse background checks; and (e) no prior training in ABA interventions.

You may not qualify if:

  • (a) chronological age other than between 18 and 48 months of age,
  • (b) nonverbal mental age less than 12 months,
  • (c) no diagnosis of autism. In addition, children will be excluded if they have a serious medical condition that would interfere with treatment (e.g., blindness, deafness, cerebral palsy).
  • a. Active duty military personnel who are unavailable due to deployment during this project will not participate, but will be offered parent training after their deployment is completed even if their data are not included in this project.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Wayne W Fisher, Ph.D.

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Autism Spectrum Disorders

Study Record Dates

First Submitted

June 5, 2012

First Posted

June 7, 2012

Study Start

May 30, 2012

Primary Completion

July 1, 2017

Study Completion

July 1, 2018

Last Updated

February 7, 2018

Record last verified: 2018-02

Locations