Clinical Trial: Direct Instruction Language for Learning in Autism Spectrum Disorder

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficacy of the Direct Instruction Language for Learning Program to Promote Expressive and Receptive Language in Children With Autism Spectrum Disorder

Brief Summary: The purpose of this study is to test whether Direct Instruction - Language for Learning (DI-LL) is an effective way to teach language skills to children with autism spectrum disorder (ASD) and moderate language delay.

Detailed Summary: Direct Instruction - Language for Learning (DI-LL) uses face to face instruction and specific lessons to teach children language skills. This method has been used previously in children with language delays, but it has not been carefully studied in children with autism spectrum disorder. This study will compare DI-LL and ongoing treatment as usual to treatment as usual (speech therapy, language services, etc.) alone.
Sponsor: Emory University

Current Primary Outcome:

• 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.

Original Primary Outcome: Change in Core Language score of the Clinical Evaluation of Language Fundamentals-4 (CELF-4) [ Time Frame: Baseline, 24 weeks ]

Current Secondary Outcome:

• 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 ]
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  Original Secondary Outcome:

  • 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.
  • Change in Improvement scale of the Clinical Global Impression scale (CGI-I) [ Time Frame: Baseline, 24 weeks ]
    The CGI-I utilizes history from primary caregiver and measures overall improvement from baseline. It involves a seven-point scale, from 1 "very much improved" to 7 "very much worse". The CGI-I will be used to assess overall response to treatment. By convention, scores of Much Improved or Very Much Improved are used to classify subjects as positive responders; all other scores result in a classification of non-responder. Lower scores indicate more improvement.
  • 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 child, a 5-minute child directed play segment in which the caregiver follows the child's lead, and a 5-minute clean-up segment in which the caregiver directs the child 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 child's one or two most important language 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 interaction, tension between parents on how to manage the problem). The baseline narrative and subsequent revisions will also be rated on a 9-point scale by a panel of judges blind to treatment assignment at the end of the study.
  • Change in Parent-rated Vineland Adaptive Behavior Scales II (Vineland-II) [ Time Frame: Baseline, 24 weeks ]
    Vineland-II will be administered and is a measure to assess adaptive skills. Scores may range from 20-160 with an average of 100 with a standard deviation of 15. Higher scores show improvement.
  • Change in Clinician-rated Children's Yale-Brown Obsessive-Compulsive Scales-Autism Spectrum Disorder (CYBOCS-ASD) [ Time Frame: Baseline, 24 weeks ]
    The CYBOCS-ASD will be administered and 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. Lower scores indicate more improvement.
  • 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, utilized is a composite score of the subscale scores. Parents who obtain a total stress score above a raw score of 90 are considered to experiencing clinically significant parenting 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 ]
    

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