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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The goal of the study is to develop an academic EF intervention, Teaching Academic Skills to Kids (TASK), for high functioning (i.e., IQ score ≥80) middle-school youth with ASD and EF deficits.
Aim 1: Use focus group methodology and advice from expert consultants to develop the TASK intervention targeting academic EF skills for middle school youth with ASD that is tailored to the unique needs of these individuals (e.g., content specific to ASD EF deficits, incorporate evidence-based teaching principles and methods for ASD).
Aim 2: Examine the feasibility and acceptability of TASK in 3 open trials to assess initial feasibility and efficacy.
The goal of the study is to develop an academic EF intervention, Teaching Academic Skills to Kids (TASK), for high functioning (i.e., IQ score ≥80) middle-school youth with ASD and EF deficits.
Aim 1: Develop the TASK intervention targeting academic EF skills for middle school youth with ASD that is tailored to the unique needs of these individuals (e.g., content specific to ASD EF deficits, incorporate evidence-based teaching principles and methods for ASD). A methodologically rigorous, well-integrated iterative and collaborative design process with input from multiple stakeholders, including school mental health professionals, teachers, parents, and youth with ASD, will be utilized.
Aim 2: Examine the feasibility and acceptability of TASK in 3 open trials including the feasibility of: 1) implementing the measurement protocol, 2) operationalizing intervention delivery, 3) assessing both trained and untrained areas of functioning, 4) assessing whether improvements in academic EF skills (proposed mechanism of treatment) are related to functional educational outcomes (e.g., homework behaviors, grades), and 5) exploring the data for potential treatment moderators (e.g., gender, severity). It is hypothesized that TASK will be feasible, acceptable (attendance, satisfaction), and will result in improved academic EF skills associated with reduced academic impairment and homework problems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Trial | Experimental | Group based treatment targeting academic executive functioning skills such as organization, planning, and study skills. Likely to be 7 90-minute sessions attended weekly by parents and teens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teaching Academic Skills to Kids | Behavioral | Group treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Children's Organizational Skills Scale | The Children's Organizational Skills Scale is a rating scale of organization and executive functioning. A T-score is reported. A T-score of 50 indicates the population mean with a standard deviation of 10. Range of possible T-scores is 40 to 90. Higher T-scores indicate poorer organization/executive functioning. We present baseline (before intervention) and 3 month outcome (post intervention) T-scores as rated by the parent. | baseline, 3 months |
| Behavior Rating Inventory of Executive Function - Second Edition | The Behavior Rating Inventory of Executive Function - Second Edition is a parent rating scale of executive functioning. A T-score is reported. A T-score of 50 indicates the population mean with a standard deviation of 10. Range of possible T-scores is 40 to 90. Higher T-scores indicate poorer executive functioning. We present baseline (before intervention) and 3 month outcome (post intervention) T-scores. | baseline, 3 months |
| Homework Problem Checklist | The Homework Problem Checklist is a rating scale of homework behavior completed by the parent. There are two subscales generated: Homework Completion Behaviors & Homework Management Behaviors. Scale is rated on a 0 = never to 3 = very often scale and a sum of scores is computed for each subscale. Range of scores for Homework Completion Behaviors is 0 to 36. Range of scores for Homework Management Behaviors is 0 to 21. We present baseline (before intervention) and 3 month outcome (post intervention) scores for each subscale. Higher scores indicate worse outcome. | baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Woodcock Johnson Tests of Achievement - Third Edition Basic Writing Subtest | The Woodcock Johnson is an academic performance measure administered to the child. A standard score of 100 indicates the population mean with a standard deviation of 15 (range of 40 to 170). Lower standard scores are worse. We present baseline (before intervention) and 3 month outcome (post intervention) for the Basic Writing subtest. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
Data will be shared with other researchers via the National Database for Autism Research (NDAR) without exposing personally identifiable information.
after August 31, 2019 when study is completed, indefinitely available.
specified by NDAR
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Youth with ASD without ID attending middle school and their parents were recruited in the 2018-2019 academic school year via letters, flyers, and emails targeted at individuals who had received services at a hospital outpatient clinic specializing in assessment and treatment of autism.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Trial | Group based treatment targeting academic executive functioning skills such as organization, planning, and study skills. Likely to be 7 90-minute sessions attended weekly by parents and teens Teaching Academic Skills to Kids: Group treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Middle school student with Autism Spectrum Disorder without Intellectual Disability
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Trial | Group based treatment targeting academic executive functioning skills such as organization, planning, and study skills. Likely to be 7 90-minute sessions attended weekly by parents and teens Teaching Academic Skills to Kids: Group treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Children's Organizational Skills Scale | The Children's Organizational Skills Scale is a rating scale of organization and executive functioning. A T-score is reported. A T-score of 50 indicates the population mean with a standard deviation of 10. Range of possible T-scores is 40 to 90. Higher T-scores indicate poorer organization/executive functioning. We present baseline (before intervention) and 3 month outcome (post intervention) T-scores as rated by the parent. | Posted | Mean | Standard Deviation | T-Score | baseline, 3 months |
|
3 months
Adverse event monitoring occurred at each assessment visit. Participants were asked if they have had any adverse experiences since the last visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Trial | Group based treatment targeting academic executive functioning skills such as organization, planning, and study skills. Likely to be 7 90-minute sessions attended weekly by parents and teens Teaching Academic Skills to Kids: Group treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leanne Tamm, Principal Investigator | Cincinnati Children's Hospital Medical Center | 513-803-3176 | leanne.tamm@cchmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2020 | Sep 22, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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Open trial
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| baseline, 3 months |
| Classroom Performance Survey | The Classroom Performance Survey is a teacher rating scale of classroom behavior. The scale is rated 1 = always to 5 = never. An academic competence mean score is computed (range 1 to 5) with higher scores indicating a worse outcome. We present baseline (before intervention) and 3 month outcome (post intervention) total mean score. | baseline, 3 months |
| Academic Performance Rating System | The Academic Performance Rating System is a teacher rating scale of academic performance. Items are rated 1 = Never to 5 = Very often and the items are summed to generate a Total Score (range 19 to 95) with higher scores worse indicating a worse outcome. We present the Total score at baseline (before intervention) and 3 month outcome (post intervention). | baseline, 3 months |
| Parenting Relationship Questionnaire - Communication Subscale | The Parenting Relationship Questionnaire is completed by parents to describe their parenting relationship with the teen. A T-score is reported for the Communication subscale. A T-score of 50 indicates the population mean with a standard deviation of 10. Range of possible T-scores is 40 to 90. Lower T-scores indicate poorer communication. We present baseline (before intervention) and 3 month outcome (post intervention) T-scores. | baseline, 3 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Kauffman Brief Intelligence Test - Second Edition | This is a brief IQ test. The Standard Score has a mean of 100 and a standard deviation of 15. Higher scores indicate higher intelligence. The range of possible scores is 40 to 160 | Mean | Standard Deviation | scores on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Behavior Rating Inventory of Executive Function - Second Edition | The Behavior Rating Inventory of Executive Function - Second Edition is a parent rating scale of executive functioning. A T-score is reported. A T-score of 50 indicates the population mean with a standard deviation of 10. Range of possible T-scores is 40 to 90. Higher T-scores indicate poorer executive functioning. We present baseline (before intervention) and 3 month outcome (post intervention) T-scores. | Posted | Mean | Standard Deviation | T-score | baseline, 3 months |
|
|
|
| Primary | Homework Problem Checklist | The Homework Problem Checklist is a rating scale of homework behavior completed by the parent. There are two subscales generated: Homework Completion Behaviors & Homework Management Behaviors. Scale is rated on a 0 = never to 3 = very often scale and a sum of scores is computed for each subscale. Range of scores for Homework Completion Behaviors is 0 to 36. Range of scores for Homework Management Behaviors is 0 to 21. We present baseline (before intervention) and 3 month outcome (post intervention) scores for each subscale. Higher scores indicate worse outcome. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months |
|
|
|
| Secondary | Woodcock Johnson Tests of Achievement - Third Edition Basic Writing Subtest | The Woodcock Johnson is an academic performance measure administered to the child. A standard score of 100 indicates the population mean with a standard deviation of 15 (range of 40 to 170). Lower standard scores are worse. We present baseline (before intervention) and 3 month outcome (post intervention) for the Basic Writing subtest. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months |
|
|
|
| Secondary | Classroom Performance Survey | The Classroom Performance Survey is a teacher rating scale of classroom behavior. The scale is rated 1 = always to 5 = never. An academic competence mean score is computed (range 1 to 5) with higher scores indicating a worse outcome. We present baseline (before intervention) and 3 month outcome (post intervention) total mean score. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months |
|
|
|
| Secondary | Academic Performance Rating System | The Academic Performance Rating System is a teacher rating scale of academic performance. Items are rated 1 = Never to 5 = Very often and the items are summed to generate a Total Score (range 19 to 95) with higher scores worse indicating a worse outcome. We present the Total score at baseline (before intervention) and 3 month outcome (post intervention). | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months |
|
|
|
| Secondary | Parenting Relationship Questionnaire - Communication Subscale | The Parenting Relationship Questionnaire is completed by parents to describe their parenting relationship with the teen. A T-score is reported for the Communication subscale. A T-score of 50 indicates the population mean with a standard deviation of 10. Range of possible T-scores is 40 to 90. Lower T-scores indicate poorer communication. We present baseline (before intervention) and 3 month outcome (post intervention) T-scores. | Posted | Mean | Standard Deviation | T-Score | baseline, 3 months |
|
|
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| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
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| 3 Month Homework Management Behaviors |
|