Direct Instruction Language for Learning in Autism Spectrum Disorder (DILL ASD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02483910|
Recruitment Status : Recruiting
First Posted : June 29, 2015
Last Update Posted : July 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder Moderate Language Delay||Behavioral: Direct Instruction-Language for Learning (DI-LL) Behavioral: Treatment as Usual||Not Applicable|
Autism spectrum disorder (ASD) is a chronic condition of early childhood onset defined by social impairment and repetitive behavior, and affecting 6 to 14 children per 1000 worldwide. Language and communication impairments are among the most common parental concerns about their children with ASD. Untreated language impairments are also predictive of negative long-term outcomes for children with ASD. Direct Instruction-Language for Learning (DI-LL) is a commercially available intervention package that has demonstrated effectiveness in children with language delays due to disadvantaged backgrounds, learning disabilities, or a primary language disorder - but it has not been carefully studied in ASD. This study will test the efficacy of DI-LL in young school-age children with ASD and moderate language delay. DI-LL is a structured, relatively inexpensive intervention designed to promote a range of language skills. It offers a comprehensive, carefully sequenced, brisk-paced program designed to teach a range of language skills to children with language impairments. A key strength of DI-LL is that it can be implemented by educators, psychologists, speech pathologists, behavior therapists without requiring deep expertise in behavioral interventions for ASD.
100 participants, ages 4 to 7 years, 11 months, will be randomly assigned to either DI-LL or Treatment as Usual (TAU). Children randomly assigned to DI-LL will be allowed to continue in ongoing treatments as well. Forty to 42 treatment sessions will occur across 24 weeks with post-treatment follow up visits at Weeks 36 and 48 for subjects in DI-LL. Negative responders to TAU at Week 24 will be offered treatment with DI-LL for 24 weeks. This study is designed to compare DI-LL and TAU on two standardized tests of language function; overall improvement rated by a blinded clinician; and the number of spoken words in a structured laboratory setting via direct observation - again blind to treatment assignment. The intent to treat approach will be used in efficacy analysis and adverse events will be monitored throughout the trial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy of the Direct Instruction Language for Learning Program to Promote Expressive and Receptive Language in Children With Autism Spectrum Disorder|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: Direct Instruction-Language for Learning
Subjects with autism spectrum disorder (ASD) plus moderate language between 4 years and 7 years 11 months will be randomly assigned to receive Direct Instruction-Language for Learning (DI-LL) for 40-48 sessions (roughly twice a week for 24 weeks). Subjects in this arm will be allowed to continue ongoing treatment during the randomized phase of the study
Behavioral: Direct Instruction-Language for Learning (DI-LL)
DI-LL is composed of up to 150 lessons (15 sets of 10 lessons each - e.g., lessons 1-10, 11-20, 21-30, etc.) that build on one another. The program uses demonstrations and pictures to expand vocabulary and teach language skills to children in manageable steps. The curriculum focuses on teaching spoken language across six areas: actions, description of objects, general information, standardized prompts ("show me" or "point to" or "say the whole thing"), classification, and problem-solving strategies. For example, DI-LL moves from the identification of familiar objects to the description and classification of these objects. Children learn the precise meaning of both familiar and new concepts and use these concepts in statements and questions. The DI-LL also incorporates 15 assessment tests (one for each set of 10 lessons). These assessment tests are given after each set of 10 lessons to confirm mastery of the material and the child's readiness to move on to the next set of 10 lessons.
Behavioral: Treatment as Usual
Usual care including speech therapy in school, community or both
Active Comparator: Treatment as Usual
Subjects with (ASD) plus moderate language between 4 years and 7 years 11 months will be randomly assigned to continue treatment as usual (TAU) for 24 weeks.
NOTE: after the randomized trial, subjects who do not show a positive response at Week 24, will be offered Direct Instruction-Language for Learning (DI-LL) for 24 weeks.
Behavioral: Treatment as Usual
Usual care including speech therapy in school, community or both
- Change in the Clinical Evaluation of Language Fundamentals-4 (CELF-4) Score [ Time Frame: Baseline, 24 weeks ]The CELF-4 English Version will be administered to assess the participant's (aged 5-8 years) receptive and expressive language skills.The Core Language score quantifies a participant's overall language performance. The standard score for the Core Language scale is based on a mean of 100 with a standard deviation of 15 (average range of 85-115). The higher the score, the better the language function of the participant.
- Change in Clinical Evaluation of Language Fundamentals-Preschool 2 (CELF-P) Score [ Time Frame: Baseline, 24 weeks ]The CELF-P English Version will be administered to assess the preschool-aged participant's receptive and expressive language skills.The Core Language score quantifies a participant's overall language performance. The standard score for the Core Language scale is based on a mean of 100 with a standard deviation of 15 (average range of 85-115). The higher the score, the better the language function of the participant.
- Change in Growth Scale Value score of the Expressive Vocabulary Test-2 (EVT-2) [ Time Frame: Baseline, 24 weeks ]The EVT-2 will be administered to measure expressive vocabulary and word retrieval for Standard American English. The Growth Scale Value (GSV) is used to monitor growth on the EVT. The GSV is a score that tracks vocabulary over time. An increase in vocabulary will result in a higher GSV score.
- Improvement item of the Clinical Global Impression scale (CGI-I) [ Time Frame: Baseline, 24 weeks ]An independent evaluator, who is blind to treatment assignment, will rate the CGI-I using all available information (e.g. Parent Nominated Problems and parent ratings) to assess overall improvement from baseline. It involves a seven-point scale, from 1 "very much improved" through 4 "no change" and 7 "very much worse." By convention, scores of Much Improved (score of 2) or Very Much Improved (score of 1) are used to define positive response; all other scores result in a classification of negative response.
- Change in Direct Observation of Spoken Language (DOSL) [ Time Frame: Baseline, 24 weeks ]DOSL incorporates fifteen minute caregiver interactions, which will be recorded on video and scored by a trained clinician, who is blind to treatment assignment. The observations will include a 5-minute parent-directed play session with the participant, a 5-minute participant directed play segment in which the caregiver follows the participant's lead, and a 5-minute clean-up segment in which the caregiver directs the participant to put toys away. A standard set of materials including books, blocks, and figurines will be provided so that families have access to similar items. The caregiver-child interactions are based on the Dyadic Parent-Child Interaction Coding System. In addition to the behaviors described in the DPICS manual, the current study will include the number of spoken words including spontaneously spoken words, echoed words, spontaneous requests or requests after parental prompt across time.
- Change in Parent-nominated Language Problems (PLPs) [ Time Frame: Baseline, 24 weeks ]Parents will be asked to describe the participant's one or two most important language or related problems. Through brief discussion the independent evaluator and the parent will co-construct a narrative to characterize each problem in behavioral terms. Narratives typically include: constancy (some of the time, most of the time, all of the time); impact on the child (avoids social interaction, retreats to socially isolated activity, gets frustrated with inability to communicate); impact of the family (family avoids social interactions, tension between parents on how to manage the problem). The baseline narrative and subsequent revisions will be used in real time to rate the CGI-I and at the end of the study on a 9-point scale by a panel of judges blind to treatment assignment.
- Change in Parent-rated Vineland Adaptive Behavior Scales II (Vineland-II) [ Time Frame: Baseline, 24 weeks ]Vineland-II is a measure of adaptive skills in every day life. Scores may range from 20-160 with an average of 100 with a standard deviation of 15. Higher scores indicate better adaptive functioning.
- Change in Clinician-rated Children's Yale-Brown Obsessive-Compulsive Scales-Autism Spectrum Disorder (CYBOCS-ASD) [ Time Frame: Baseline, 24 weeks ]The CYBOCS-ASD is a semi-structured clinician-rated scale designed to rate the current severity of repetitive behavior in children with autism spectrum disorder (ASD). Once the current repetitive behaviors are identified, they are rated on: Time Spent, Interference, Distress, Resistance, and Control. Each of these items is scored from 0 (least symptomatic) to 4 (most symptomatic), yielding a Total score from 0 to 20. Higher scores indicate higher severity.
- Change in Parenting Stress Index - Short Form (PSI-SF) [ Time Frame: Baseline, 24 weeks ]The PSI-SF is a parent-report questionnaire of parental stress, parent-child interaction style, and difficult child behaviour that will be used to measure changes in parental stress. It is a 36-item questionnaire for families of children 12 years of age and younger. Each of these items is scored using the following 5-point scale: 1 (strongly agree) to 5 (strongly disagree). The total stress score is a composite of the three subscales. Higher scores indicate higher parental stress.
- Change in Caregiver Strain Questionnaire (CGSC) [ Time Frame: Baseline, 24 weeks ]The CGSC measures the impact of having a child with ASD on the family. The questionnaire includes 21 items that assess three dimensions of caregiver strain: objective strain, internalized subjective strain, and externalized subjective strain. Each item is rated on a 5-point scale ranging from 1(not at all a problem) to 5 (very much a problem). The total score can range from a minimum of 0 - no strain at all, to 110 all items rated as very much.
- Parent Satisfaction Survey [ Time Frame: 24 weeks ]Parent satisfaction survey will be administered at the end of the treatment period. It is a 13-item parent satisfaction survey and each item is scored using the following 6-point scale: 1 (strongly disagree) to 6 (strongly agree). Total scores are reported with a minimum of 6 and a maximum of 78, with higher scores indicating higher satisfaction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483910
|Contact: Rebecca Kilbourne||404-785-1883||Rebecca.Kilbourne@choa.org|
|Contact: Christopher Page||404-785-9796||Christopher.Page@choa.org|
|United States, Georgia|
|Marcus Autism Center - Children's Healthcare of Atlanta||Recruiting|
|Atlanta, Georgia, United States, 30329|
|Contact: Crystal Bowen, MS 404-785-9457 firstname.lastname@example.org|
|Principal Investigator:||Lawrence Scahill, MSN, PhD||Emory University|