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| Name | Class |
|---|---|
| Rady Children's Hospital, San Diego | OTHER |
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The purpose of this project is to conduct a feasibility test of an ASD executive functioning intervention adapted for mental health settings, including examining the effectiveness and process of implementing this adapted intervention in community mental health programs.
This project will examine the implementation and effectiveness of an ASD executive functioning intervention, entitled Unstuck and On Target, adapted for use in community mental health clinics. Minimizing the impact of executive functioning deficits in youth has broad public health implications, including improving the effectiveness of mental health services for youth such as those with autism spectrum disorders (ASD) and attention-deficit/hyperactivity disorder (ADHD). Improved executive functioning also has the potential for improvement in real-world functioning, including daily living skills, mental health, and educational outcomes. Although Unstuck and On Target is an established evidence-based intervention, the effectiveness of this intervention in mental health settings has not been established. Therefore, the primary aim is to collect data on implementation outcomes of the adapted intervention, including feasibility, utility, and therapist fidelity, in mental health settings. The secondary aim is to collect data on the preliminary effectiveness of Unstuck and On Target adapted for mental health settings. This study has the potential to make a significant impact by building local capacity to serve school-age children with executive functioning deficits in routine service settings, and advancing the science on the effectiveness of an established evidence-based practice (Unstuck and On Target) for specific services settings. It will also produce generalizable knowledge about implementation that can be applied for this population/setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Community therapists delivering routine care to participant children with no training in Unstuck and on Target | |
| Unstuck and on Target Training | Experimental | Therapists enrolled in Unstuck and on Target Training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unstuck and on Target | Behavioral | Unstuck and on Target is a cognitive-behavioral treatment that directly addresses executive functioning and self-regulation deficits in ASD and ADHD. Unstuck and on Target is the first contextually-based executive functioning treatment that targets flexibility, goal-setting and planning through a cognitive behavioral program centered on self-regulatory scripts that are consistently modeled and reinforced. Unstuck and on Target will be adapted for use in mental health service settings. Mental health therapists will be trained in Unstuck and on Target and deliver to youth and caregivers. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Intervention Measure | The Acceptability of Intervention Measure (AIM) measure includes four items assessing the acceptability of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher acceptability. This measure were designed to assess mental health providers' perceptions regarding acceptability of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Scores are an overall mean score. | 6 months after starting implementation |
| Intervention Appropriateness Measure | The Intervention Appropriateness Measure (IAM) measure includes four items assessing the appropriateness of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher appropriateness. This measure was designed to assess mental health providers' perceptions regarding appropriateness of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Scores are an overall mean score. | 6 months after starting implementation |
| Feasibility of Intervention Measure | The Feasibility of Intervention Measure (FIM) measure includes 4 items assessing the feasibility of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher feasibility. This measure was designed to assess mental health providers' perceptions regarding feasibility of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Scores are an overall mean score. | 6 months after starting implementation |
| Average of Provider Fidelity Throughout Implementation Period |
| Measure | Description | Time Frame |
|---|---|---|
| Eyberg Child Behavior Inventory | The Eyberg Child Behavior Inventory is a 36 item questionnaire of child behavior. Caregivers of participating youth completed the questionnaire to assess their perceptions of their child's disruptive behaviors. The Eyberg Child Behavior Inventory Intensity Scale score measures the frequency of a child's behavioral problems and ranges from 36 (minimum value) to 352 (maximum). A score of 127 or higher is considered to be in the clinical range. The values reported below represent the mean change in the average T-score from baseline to 6 months post intervention for each condition group. Negative values represent an overall decrease in problem behaviors (better outcome) while positive values representing an increase in problem behaviors (worse outcome) from baseline to post when looking at the condition groups as a whole. |
| Measure | Description | Time Frame |
|---|---|---|
| Wechsler Abbreviated Scale of Intelligence Second Edition- Block Design Subscale | The Wechsler Abbreviated Scale of Intelligence Second Edition, is a brief measure of intelligence. We administered the Block Design subscale, a timed visual construction task that measures changes in nonverbal reasoning ability by assessing an individual's capacity to analyze and synthesize abstract visual stimuli, demonstrating visual-spatial skills, and coordinating visual perception with motor actions to replicate geometric patterns using colored blocks.The subtest is scored by converting the raw scores into scale scores using standardized norms. Scores range from 1 (minimum) to 19 (maximum) with an average of 10. Values below represent the change in subscale scaled scores from baseline to post-intervention for participating children. Negative values represent an overall decrease in nonverbal reasoning ability (worse outcome) while positive values represent and overall increase in nonverbal reasoning ability (better outcome). |
Inclusion Criteria for Therapists:
Inclusion Criteria for Child Participants
Exclusion Criteria for Child/ Parent Participants
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Child and Adolescent Services Research Center | San Diego | California | 92123 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32699642 | Background | Dickson KS, Aarons GA, Anthony LG, Kenworthy L, Crandal BR, Williams K, Brookman-Frazee L. Adaption and pilot implementation of an autism executive functioning intervention in children's mental health services: a mixed-methods study protocol. Pilot Feasibility Stud. 2020 Apr 27;6:55. doi: 10.1186/s40814-020-00593-2. eCollection 2020. |
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Numbers pertaining to those who started and completed don't match the protocol number. Participant numbers in fact exceeded the numbers for protocol enrollment with the exception of Usual Care: Children. Reason for this inconsistency is due to child recruitment at the start of the COVID 19 pandemic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care: Therapist | Community therapists delivering routine care in a community health setting. Note: some therapists enrolled with more than one child. |
| FG001 | Unstuck and On Target Therapist | Community therapists trained in delivering Unstuck and On Target in a community health setting. Note: some therapists enrolled with more than one child. |
| FG002 | Usual Care: Children | Children with suspected or diagnosed ASD receiving care with a participating therapist. |
| FG003 | Unstuck and On Target: Children | Children with suspected or diagnosed ASD receiving care with a participating therapist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Numbers represent participating therapists and their yolked child participants. Note that some therapists participated with more than 1 child during the study.
For 1 Usual Care: Therapist, partial baseline data is missing.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care: Therapists | Community therapists delivering routine care in a community health setting. Note: some therapists enrolled with more than one child. |
| BG001 | Unstuck and On Target: Therapists |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Total column represents the combined mean of therapist and child ages. |
| 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 | Acceptability of Intervention Measure | The Acceptability of Intervention Measure (AIM) measure includes four items assessing the acceptability of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher acceptability. This measure were designed to assess mental health providers' perceptions regarding acceptability of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Scores are an overall mean score. | Measure only administered to Therapist intervention (Unstuck and On Target) group | Posted | Mean | Standard Deviation | score on a scale | 6 months after starting implementation |
|
Adverse events data monitored throughout the 2 year study. Broader oversight for adverse events was provided by a Data Safety and Monitoring Committee (DSMB) selected before data collection began. The DSMB met repeatedly during the study at an average of 2 times a year through study completion (average of 4 meetings over the 2 year duration of the study).
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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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 | Usual Care: Therapists | Community therapists delivering routine care to participant children with no training in Unstuck and on Target |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| No Adverse Events were observed during the course of the study | Psychiatric disorders | Systematic Assessment | No Adverse Events were observed during the course of the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelsey Dickson | San Diego State University | (619) 594-5380 | q | kdickson@sdsu.edu |
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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 | Apr 27, 2020 | Jan 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
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Provider adherence or fidelity to the Unstuck and On Target intervention will be measured through observational coding of provider in-session behaviors using the fidelity measure developed as part of the Unstuck and On Target intervention. Observers rate the provider's use of Unstuck and On Target on 9 components, using a 5-point (1 to 5) Likert scale, with higher scores indicating higher fidelity. For this report, a single, averaged value of all fidelity scores has been calculated per component. |
| A single, averaged value of all fidelity scores has been calculated. Average fidelity represents scores over the course of 6 months of therapist implementation. Table rows represent different aspects of fidelity that were scored. |
| Child Behavior Checklist | Child Behavior Checklist (CBCL) is a parent-report measure of child problem behavior. The CBCL is divided into three broadband scales (Internalizing, Externalizing, and Total Problem Scores) and several associate subscale scores. For this study, only the broadband scales were utilized for analyses. Scores are represented as T-scores with a population mean of 50 with standard deviation of 10 and ranges from 30 (minimum) to 95 (maximum. Higher scores reflect more mental health symptoms. The values reported below represent the mean change in the T-scores from the Total, Internalizing, and Externalizing T-Scores from baseline to 6 months post intervention for each condition group. Negative values represent an overall decrease in symptoms (better outcome) while positive values representing an increase in problem behaviors (worse outcome) from baseline to post when looking at the condition groups as a whole. | At baseline and 6 months post-implementation. |
| At baseline and 6 months post-implementation. |
| At baseline and 6 months post-implementation. |
| Executive Functioning Challenge Task | The Executive Functioning Challenge Task deliberately tests a child's ability to utilize key executive functions like planning and flexibility by presenting scenarios that reveal potential areas of difficulty in their executive functioning skills. The test yields Flexibility and Planning raw scores with a minimum of 0 and maximum of 8. Higher scores indicate greater impairment in executive functioning. A total executive functioning raw score is also calculated as the sum of planning and flexibility scores. Values below represent the change in average raw scores from baseline to post-intervention for participating children. Negative scores represent an overall decrease in executive functioning impairment (better outcome) while positive scores representing an increase in executive functioning impairment (worse outcome) from baseline to post when looking at the condition groups as a whole. | At baseline and 6 months post-implementation. |
| Behavior Rating Inventory of Executive Function Second Edition | The Behavior Rating Inventory of Executive Function- Second Edition is a 63-item rating scale completed by caregivers to assess executive function impairment in children. T scores have a population mean of 50 and standard deviation of 10, with a minimum score of 30 and maximum score of 95. Scales assessed included the Behavioral Regulation Index, Emotion Regulation Index and Cognitive Regulation Index, together forming an overall composite score, the Global Executive Composite. Values below represent the change in T-scores scores from baseline to post-intervention for participating children. T scores at or above 70 are considered clinically significant. Scores represent the change in T scores from baseline to post. Negative values represent decrease in impairment (better outcome) while positive scores representing an increase in impairment (worse outcome) from baseline to post when looking at the condition groups as a whole. | At baseline and 6 months post-implementation. |
| Therapist did not refer eligible family |
|
Community therapists trained in delivering Unstuck and On Target in a community health setting. Note: some therapists enrolled with more than one child.
| BG002 | Usual Care: Children | Children with suspected or diagnosed ASD receiving care with a participating therapist. |
| BG003 | Unstuck and On Target: Children | Children with suspected or diagnosed ASD receiving care with a participating therapist. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Overall number represents child participants. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Overall number represents child participants. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Overall number represents child participants. | Overall number represents child participants. | Count of Participants | Participants |
|
| Region of Enrollment | All therapist and child participants reside in the Southwestern United States. | Count of Participants | Participants |
|
| Child-Baseline Measures | The Social Responsiveness Scale measures social behavior differences associated with autism. Ratings from all subscales are summed to determine an overall score represented as T-scores (Mean=50, SD=10; Min=30; Max=95), with and higher scores reflecting more disruptive behaviors. The Wechsler Abbreviated Scale of Intelligence-2nd Edition is a standardized assessment of cognitive ability consisting of four subtests that yield a full score. Each score is represented as a standard score (Mean=100, SD=15; Min=40; Max=160), with higher scores reflective of higher functioning. | Baseline measures were only collected for enrolled children and not for therapists. Thus, therapist values are 0 | Mean | Standard Deviation | units on a scale |
|
Community therapists trained and delivering Unstuck and On Target to participant children
|
|
| Primary | Intervention Appropriateness Measure | The Intervention Appropriateness Measure (IAM) measure includes four items assessing the appropriateness of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher appropriateness. This measure was designed to assess mental health providers' perceptions regarding appropriateness of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Scores are an overall mean score. | Measure only administered to Therapist intervention (Unstuck and On Target) group | Posted | Mean | Standard Deviation | score on a scale | 6 months after starting implementation |
|
|
|
| Primary | Feasibility of Intervention Measure | The Feasibility of Intervention Measure (FIM) measure includes 4 items assessing the feasibility of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher feasibility. This measure was designed to assess mental health providers' perceptions regarding feasibility of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Scores are an overall mean score. | Measure only administered to Therapist intervention (Unstuck and On Target) group | Posted | Mean | Standard Deviation | score on a scale | 6 months after starting implementation |
|
|
|
| Primary | Average of Provider Fidelity Throughout Implementation Period | Provider adherence or fidelity to the Unstuck and On Target intervention will be measured through observational coding of provider in-session behaviors using the fidelity measure developed as part of the Unstuck and On Target intervention. Observers rate the provider's use of Unstuck and On Target on 9 components, using a 5-point (1 to 5) Likert scale, with higher scores indicating higher fidelity. For this report, a single, averaged value of all fidelity scores has been calculated per component. | Community therapists randomized to either usual care or intervention condition working with youth clients with an autism spectrum disorder. | Posted | Mean | Standard Deviation | score on a scale | A single, averaged value of all fidelity scores has been calculated. Average fidelity represents scores over the course of 6 months of therapist implementation. Table rows represent different aspects of fidelity that were scored. |
|
|
|
| Primary | Child Behavior Checklist | Child Behavior Checklist (CBCL) is a parent-report measure of child problem behavior. The CBCL is divided into three broadband scales (Internalizing, Externalizing, and Total Problem Scores) and several associate subscale scores. For this study, only the broadband scales were utilized for analyses. Scores are represented as T-scores with a population mean of 50 with standard deviation of 10 and ranges from 30 (minimum) to 95 (maximum. Higher scores reflect more mental health symptoms. The values reported below represent the mean change in the T-scores from the Total, Internalizing, and Externalizing T-Scores from baseline to 6 months post intervention for each condition group. Negative values represent an overall decrease in symptoms (better outcome) while positive values representing an increase in problem behaviors (worse outcome) from baseline to post when looking at the condition groups as a whole. | Children with suspected or diagnosed ASD receiving care with a participating therapist. | Posted | Mean | Standard Deviation | units on a scale | At baseline and 6 months post-implementation. |
|
|
|
| Secondary | Eyberg Child Behavior Inventory | The Eyberg Child Behavior Inventory is a 36 item questionnaire of child behavior. Caregivers of participating youth completed the questionnaire to assess their perceptions of their child's disruptive behaviors. The Eyberg Child Behavior Inventory Intensity Scale score measures the frequency of a child's behavioral problems and ranges from 36 (minimum value) to 352 (maximum). A score of 127 or higher is considered to be in the clinical range. The values reported below represent the mean change in the average T-score from baseline to 6 months post intervention for each condition group. Negative values represent an overall decrease in problem behaviors (better outcome) while positive values representing an increase in problem behaviors (worse outcome) from baseline to post when looking at the condition groups as a whole. | Children with suspected or diagnosed ASD receiving care with a participating therapist. | Posted | Mean | Standard Deviation | units on a scale | At baseline and 6 months post-implementation. |
|
|
|
| Other Pre-specified | Wechsler Abbreviated Scale of Intelligence Second Edition- Block Design Subscale | The Wechsler Abbreviated Scale of Intelligence Second Edition, is a brief measure of intelligence. We administered the Block Design subscale, a timed visual construction task that measures changes in nonverbal reasoning ability by assessing an individual's capacity to analyze and synthesize abstract visual stimuli, demonstrating visual-spatial skills, and coordinating visual perception with motor actions to replicate geometric patterns using colored blocks.The subtest is scored by converting the raw scores into scale scores using standardized norms. Scores range from 1 (minimum) to 19 (maximum) with an average of 10. Values below represent the change in subscale scaled scores from baseline to post-intervention for participating children. Negative values represent an overall decrease in nonverbal reasoning ability (worse outcome) while positive values represent and overall increase in nonverbal reasoning ability (better outcome). | Children with suspected or diagnosed ASD receiving care with a participating therapist. | Posted | Mean | Standard Deviation | units on a scale | At baseline and 6 months post-implementation. |
|
|
|
| Other Pre-specified | Executive Functioning Challenge Task | The Executive Functioning Challenge Task deliberately tests a child's ability to utilize key executive functions like planning and flexibility by presenting scenarios that reveal potential areas of difficulty in their executive functioning skills. The test yields Flexibility and Planning raw scores with a minimum of 0 and maximum of 8. Higher scores indicate greater impairment in executive functioning. A total executive functioning raw score is also calculated as the sum of planning and flexibility scores. Values below represent the change in average raw scores from baseline to post-intervention for participating children. Negative scores represent an overall decrease in executive functioning impairment (better outcome) while positive scores representing an increase in executive functioning impairment (worse outcome) from baseline to post when looking at the condition groups as a whole. | Children with suspected or diagnosed ASD receiving care with a participating therapist. | Posted | Mean | Standard Deviation | units on a scale | At baseline and 6 months post-implementation. |
|
|
|
| Other Pre-specified | Behavior Rating Inventory of Executive Function Second Edition | The Behavior Rating Inventory of Executive Function- Second Edition is a 63-item rating scale completed by caregivers to assess executive function impairment in children. T scores have a population mean of 50 and standard deviation of 10, with a minimum score of 30 and maximum score of 95. Scales assessed included the Behavioral Regulation Index, Emotion Regulation Index and Cognitive Regulation Index, together forming an overall composite score, the Global Executive Composite. Values below represent the change in T-scores scores from baseline to post-intervention for participating children. T scores at or above 70 are considered clinically significant. Scores represent the change in T scores from baseline to post. Negative values represent decrease in impairment (better outcome) while positive scores representing an increase in impairment (worse outcome) from baseline to post when looking at the condition groups as a whole. | Children with suspected or diagnosed ASD receiving care with a participating therapist. | Posted | Mean | Standard Deviation | units on a scale | At baseline and 6 months post-implementation. |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Unstuck and On Target: Therapists | Community therapists delivering Unstuck and On Target to participant children | 0 | 23 | 0 | 23 | 0 | 23 |
| EG002 | Usual Care: Children | Children with suspected or diagnosed ASD receiving care with a participating therapist. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG003 | Unstuck and On Target: Children | Children with suspected or diagnosed ASD receiving care with a participating therapist. | 0 | 22 | 0 | 22 | 0 | 22 |
|
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Use of Visuals |
|
| Use of Handouts |
|
| Use of Vocabulary |
|
| Goal, Why, Plan, Do, Check |
|
| Models Skills (Flexibility, planning) |
|
| Use of More Positive Praise than Correction |
|
| Use of Parent Engagement Strategies |
|
| Change in Externalizing Behavior Score |
|
| Change in Executive Functioning Total Score |
|
| Change in Cognitive Regulation Index T-Score |
|
| Change in Global Executive Composite T-Score |
|