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Community Based Intervention for Children With ADHD and ASD

Primary Purpose

Autism Spectrum Disorder, Attention Deficit-Hyperactivity Disorder, Executive Function

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unstuck and on Target (UOT)
Parents and Teachers Supporting Students (PATSS)
Sponsored by
Lauren Kenworthy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Contingency Behavior Management, Flexible, Unstuck, Low Income, Behavior, Coping, Disparity, Problem Solving, Self-Control, impulsive, intervention

Eligibility Criteria

8 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The investigators will recruit children who are referred by teachers and staff at their school for concerns of flexibility (rather than those who are responding to an advertisement), so that the research will have a "real world" group of children to test the effectiveness of the treatments.
  • The recruited participants will have symptoms of ASD or ADHD, will be receiving a combination of mainstream and special education supports, and will qualify to attend pull-out groups in school. All the schools involved are eligible for Title 1 governmental support, indicating that the children are from primarily low-income communities, although the investigators will not be requiring that participant's families themselves meet income cutoffs.
  • Potential participants will be evaluated individually and included in the study if they achieve a Full Scale IQ score>70, a verbal mental age>6 years old, and meet DSM-IV-TR criteria for either a Autism Spectrum Disorder or ADHD. IQ and verbal mental age will be measured with the Wechsler Abbreviated Scale of Intelligence, 2nd addition (WASI-2) Verbal, Performance and Full Scale IQ scores (represented as Standard Scores: mean=100; SD=15).
  • To evaluate for ASD, research-valid clinical psychologists will administer the Autism Diagnostic Observation Schedule, Second Edition Module 3 (ADOS-2), a gold standard structured play/conversational interview that elicits symptoms of ASD. It produces non-standardized raw scores; higher scores indicate more symptoms. To be included in the study, each child must obtain an ADOS diagnostic algorithm >'ASD' threshold and parents will be asked to complete the Social and Communication Questionnaire (SCQ). In order to include the full autism spectrum, these criteria are relatively inclusive.
  • To confirm diagnosis of ADHD, parents will complete the ADHD portion of the MINI-Kid ADHD interview with a trained interviewer, and their child must meet DSM-IV criteria for any Attention Disorder. The researchers will include children who had observable symptoms in two of three settings. As all children will be referred for the study because teachers or staff at their school observed symptoms, the children will have to also meet criteria on the MINI-Kid interview or the trained clinician completing their testing will have to observe notable symptoms, or both, for the child to be included in the study.

Exclusion Criteria:

  • Participants will be excluded from the study if they have a diagnosis of bipolar disorder, schizophrenia, or major depression that is currently preventing them from participating in classroom activities.
  • Students with anxiety, mild depression, obsessive-compulsive disorder or other problems that do not prevent them from participating in the majority of classroom activities will not be excluded.
  • Exclusion will be determined through a two-stage process: First, participants will be screened for comorbid symptoms using the Child Behavior Checklist (CBCL). The CBCL for 6-18 year olds has 118 items that describe specific behavioral and emotional problems. Parents rate their child for how true each item is now or within the past 6 months. One of the PIs, both of whom are licensed psychologists with active clinical practices, will follow-up with a child's teacher if a child scores above a T score of 75 on any of the six DSM-oriented scales other than Attention Deficit/Hyperactivity Problems (Affective Problems; Anxiety Problems; Somatic Problems; Oppositional Defiant Problems; and Conduct Problems).
  • The investigators will ask teachers targeted questions to determine to what degree the identified symptoms interfere with the child's ability to participate in the classroom activities or in the treatment group such as "Do you feel that the child can participate in most classroom activities? If not, why? Can they listen to and follow written and verbal instructions? Can they participate in activities with other children when given structure and support?" However, because the school programs involved in this study use an inclusion model, students in these mainstream classrooms are unlikely to meet exclusion criteria.

Sites / Locations

  • Children's Research Institude, Children's National Heath System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

UOT Students and Parents

PATSS Students and Parents

Arm Description

Unstuck and on Target (UOT) provided in the classroom for students at Title 1 schools

Parents and Teachers Supporting Students (PATSS) provided in the classroom for students at Title 1 schools

Outcomes

Primary Outcome Measures

Change in Classroom Observation total raw score at termination of intervention
15-20 minute classroom observation conducted by a treatment-blind research assistant for every study participant during the academic school day. The following behaviors are coded: Social reciprocity, Following Rules, Transitions, Gets Stuck, Negativity/Overwhelm, and Classroom Participation.

Secondary Outcome Measures

Change in Wechsler Abbreviated Scale of Intelligence--II Block Design- T-score at termination of intervention (post testing) and 1 year later (long-term follow-up)
A standardized, normed timed visual construction task that requires efficient nonverbal cognitive problem solving.
Change in Delis-Kaplan Executive Function System - Category Fluency and Switching Accuracy scaled scores at termination of intervention (post testing) and 1 year later (long-term follow-up)
Standardized, normed, executive function tasks
Change in Executive Function Challenge Task - Flexibility and Planning raw scores at termination of intervention (post testing) and 1 year later (long-term follow-up)
Observations of participant behavior when confronted with 3 standardized tasks demanding flexibility and planning are coded on a 3-point scale for each task, and summed across tasks.
Change in Flexibility Interference Questions Questionnaire total raw score at termination of intervention (post testing) and 1 year later (long-term follow-up)
A short questionnaire was created by researchers for parents to report how often problems with flexibility interfere with daily adaptive functioning.
Change in Behavior Rating Inventory of Executive Function (BRIEF) - Parent Form - Shift, Plan/Organize, Emotional Control and Global Executive at termination of intervention (post testing) and 1 year later (long-term follow-up)Composite T-scores
Parent ratings of participant's executive function-related behaviors
Change in The Child Behavior Checklist (CBCL) - Parent Report Externalizing Behaviors T-scores at termination of intervention (post testing) and 1 year later (long-term follow-up)
The CBCL for 6-18 year olds has 118 items that describe specific behavioral and emotional problems, plus two open ended items to describe any additional problems, as well as 20 competence items covering positive, pro-social behaviors. Children's scores are expressed as T scores (mean=50; SD=10) on eight empirically based syndromes scales which are based on factor analyses: Anxious/Depressed, Withdrawn/Depressed, Somatic Complaints, Social Problems, Thought Problems, Attention Problems, Rule-Breaking Behavior, and Aggressive Behavior. The CBCL will be used to track behavioral change at home as a result of the treatments. Researchers predict that UOT and CBM participants will improve equally on the Aggressive Behavior scale, but that UOT participants will improve more on the CBCL Affective Problems score than CBM participants.
Parent Feedback Form - Acceptability total raw score
Parent ratings of acceptability of the intervention
Child Feedback-Acceptability raw score
Child ratings of acceptability of the intervention

Full Information

First Posted
November 21, 2016
Last Updated
April 2, 2018
Sponsor
Lauren Kenworthy
Collaborators
Georgetown University, University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT03003286
Brief Title
Community Based Intervention for Children With ADHD and ASD
Official Title
Community Based Intervention for Children With ADHD and ASD
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 13, 2014 (Actual)
Primary Completion Date
August 5, 2017 (Actual)
Study Completion Date
August 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lauren Kenworthy
Collaborators
Georgetown University, University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether a new treatment, Unstuck and On Target (UOT), works better, worse, or the same as the best treatment that is available now, Contingency Behavioral Management (CBM), for low income children with Autism Spectrum Disorder (ASD) or Attention Deficit Hyperactivity Disorder (ADHD).
Detailed Description
This project will compare the effectiveness of an innovative community-based cognitive-behavioral Executive Functioning (EF) treatment, Unstuck and On Target (UOT) to the current standard of care, a Contingency Behavioral Management (CBM) program in typically underserved children with ASD or ADHD. Minimizing the impact of EF deficits in these pediatric disorders has broad public health implications, providing the opportunity for improvement in the real-world, long-term outcomes that stakeholders have told the investigators are most important to them: more educational and vocational success, more functional independence and improved Activities of Daily Living skills, and better physical health, with reduced morbidity and mortality. The health disparity that this project addresses is the poorer outcomes and limited treatment choices associated with being a child from a low-income family who also has ADHD or ASD. The research questions are: Which works better for low-income children with ASD, UOT or CBM? Researchers will test the comparative effectiveness of UOT to CBM treatments with low-income children with ASD. Which works better for low-income children with ADHD, UOT or CBM? Researchers will test the comparative effectiveness of UOT to CBM with low-income children with ADHD, a new patient population for UOT. Are the effects of UOT and CBM sustained 9-12 months after treatment? Researchers will assess whether any benefits ascribed to the interventions are maintained about a year after the treatment is completed. Patients with ASD and ADHD will be recruited for the study from school systems. Half will receive UOT and half will receive CBM. Researchers will recruit interested Title 1 schools that serve very different and diverse populations. Recruitment will occur in several stages. Specifically, school districts will invite individual schools to participate in the trial that have a sufficient number of qualifying children. Interested schools will then contact families and provide information about the study. Interested families will initiate contact with study staff, and individual schools will be entered into the study if they have three or more patients whose families contact study staff. Children will then be scheduled for cognitive/diagnostic evaluation. Recruitment will continue until the target enrollment is reached, and all remaining interested families from enrolled schools are included. Subjects with appropriate assent and consent will be evaluated for eligibility and their school will be randomly assigned to treatment condition. Cognitive problem-solving abilities, flexibility, planning and organizing, self-regulation, behavior problems, coping skills, and the child's use of non-routine urgent medical care will be measured before and after treatment through a multi-method, multi-informant format, including parent report, blinded classroom observations and blinded direct child measures. Researchers chose measures that have the greatest relevance to functional outcomes and "real world" functioning. Rather than define a single outcome, researchers chose multiple outcome variables, anticipating differential impacts of the treatment modalities on the outcome domains. All of the measures and observations will be gathered at pre- and post-treatment time-points in each treatment year. Data will be analyzed using a Statistical Package for the Social Sciences (SPSS) v20 and R. A comparison of baseline characteristics will be performed between the treatment groups to assess that the randomization was successful. The characteristics will include demographics as well as the direct child assessments and the behavioral scales. These comparisons will be performed using standard statistical methods, such as t-tests for continuous variables or (exact) chi-squares for dichotomous variables. If any characteristic is unbalanced between treatments, which will be possible with the sample size, secondary analyses will adjust for that characteristic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Attention Deficit-Hyperactivity Disorder, Executive Function
Keywords
Contingency Behavior Management, Flexible, Unstuck, Low Income, Behavior, Coping, Disparity, Problem Solving, Self-Control, impulsive, intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UOT Students and Parents
Arm Type
Experimental
Arm Description
Unstuck and on Target (UOT) provided in the classroom for students at Title 1 schools
Arm Title
PATSS Students and Parents
Arm Type
Experimental
Arm Description
Parents and Teachers Supporting Students (PATSS) provided in the classroom for students at Title 1 schools
Intervention Type
Behavioral
Intervention Name(s)
Unstuck and on Target (UOT)
Intervention Description
Unstuck and on Target (UOT) is a novel and innovative cognitive-behavioral treatment that directly addresses executive functioning and self-regulation deficits in ASD and ADHD. UOT is the first contextually-based EF treatment that targets flexibility, goal-setting and planning through a cognitive-behavioral program centered on self-regulatory scripts that are consistently modeled and reinforced. Parents, teachers, and interventionists will be taught to model and support flexibility across settings. Children will also participate in a peer group intervention setting.
Intervention Type
Behavioral
Intervention Name(s)
Parents and Teachers Supporting Students (PATSS)
Intervention Description
The Contingency Behavior Management (CBM) intervention was developed by the researchers and called Parents and Teachers Supporting Students (PATSS) as a current best practice intervention that was comparable in design to Unstuck and on Target. The goal is to improve child behavioral outcomes by training parents, teachers and interventionists in core principles of behavior management like social learning and behavioral change. Children were also included in small group sessions where they identify their own behavior goals and meaningful reinforcers.
Primary Outcome Measure Information:
Title
Change in Classroom Observation total raw score at termination of intervention
Description
15-20 minute classroom observation conducted by a treatment-blind research assistant for every study participant during the academic school day. The following behaviors are coded: Social reciprocity, Following Rules, Transitions, Gets Stuck, Negativity/Overwhelm, and Classroom Participation.
Time Frame
Baseline, 7-8 months
Secondary Outcome Measure Information:
Title
Change in Wechsler Abbreviated Scale of Intelligence--II Block Design- T-score at termination of intervention (post testing) and 1 year later (long-term follow-up)
Description
A standardized, normed timed visual construction task that requires efficient nonverbal cognitive problem solving.
Time Frame
Baseline, 7-8 months, 19-20 months
Title
Change in Delis-Kaplan Executive Function System - Category Fluency and Switching Accuracy scaled scores at termination of intervention (post testing) and 1 year later (long-term follow-up)
Description
Standardized, normed, executive function tasks
Time Frame
Baseline, 7-8 months,19-20 months
Title
Change in Executive Function Challenge Task - Flexibility and Planning raw scores at termination of intervention (post testing) and 1 year later (long-term follow-up)
Description
Observations of participant behavior when confronted with 3 standardized tasks demanding flexibility and planning are coded on a 3-point scale for each task, and summed across tasks.
Time Frame
Baseline, 7-8 months, 19-20 months
Title
Change in Flexibility Interference Questions Questionnaire total raw score at termination of intervention (post testing) and 1 year later (long-term follow-up)
Description
A short questionnaire was created by researchers for parents to report how often problems with flexibility interfere with daily adaptive functioning.
Time Frame
Baseline, 7-8 months, 19-20 months
Title
Change in Behavior Rating Inventory of Executive Function (BRIEF) - Parent Form - Shift, Plan/Organize, Emotional Control and Global Executive at termination of intervention (post testing) and 1 year later (long-term follow-up)Composite T-scores
Description
Parent ratings of participant's executive function-related behaviors
Time Frame
Baseline, 7-8 months, 19-20 months
Title
Change in The Child Behavior Checklist (CBCL) - Parent Report Externalizing Behaviors T-scores at termination of intervention (post testing) and 1 year later (long-term follow-up)
Description
The CBCL for 6-18 year olds has 118 items that describe specific behavioral and emotional problems, plus two open ended items to describe any additional problems, as well as 20 competence items covering positive, pro-social behaviors. Children's scores are expressed as T scores (mean=50; SD=10) on eight empirically based syndromes scales which are based on factor analyses: Anxious/Depressed, Withdrawn/Depressed, Somatic Complaints, Social Problems, Thought Problems, Attention Problems, Rule-Breaking Behavior, and Aggressive Behavior. The CBCL will be used to track behavioral change at home as a result of the treatments. Researchers predict that UOT and CBM participants will improve equally on the Aggressive Behavior scale, but that UOT participants will improve more on the CBCL Affective Problems score than CBM participants.
Time Frame
Baseline, 7-8 months, 19-20 months
Title
Parent Feedback Form - Acceptability total raw score
Description
Parent ratings of acceptability of the intervention
Time Frame
7-8 months
Title
Child Feedback-Acceptability raw score
Description
Child ratings of acceptability of the intervention
Time Frame
7-8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The investigators will recruit children who are referred by teachers and staff at their school for concerns of flexibility (rather than those who are responding to an advertisement), so that the research will have a "real world" group of children to test the effectiveness of the treatments. The recruited participants will have symptoms of ASD or ADHD, will be receiving a combination of mainstream and special education supports, and will qualify to attend pull-out groups in school. All the schools involved are eligible for Title 1 governmental support, indicating that the children are from primarily low-income communities, although the investigators will not be requiring that participant's families themselves meet income cutoffs. Potential participants will be evaluated individually and included in the study if they achieve a Full Scale IQ score>70, a verbal mental age>6 years old, and meet DSM-IV-TR criteria for either a Autism Spectrum Disorder or ADHD. IQ and verbal mental age will be measured with the Wechsler Abbreviated Scale of Intelligence, 2nd addition (WASI-2) Verbal, Performance and Full Scale IQ scores (represented as Standard Scores: mean=100; SD=15). To evaluate for ASD, research-valid clinical psychologists will administer the Autism Diagnostic Observation Schedule, Second Edition Module 3 (ADOS-2), a gold standard structured play/conversational interview that elicits symptoms of ASD. It produces non-standardized raw scores; higher scores indicate more symptoms. To be included in the study, each child must obtain an ADOS diagnostic algorithm >'ASD' threshold and parents will be asked to complete the Social and Communication Questionnaire (SCQ). In order to include the full autism spectrum, these criteria are relatively inclusive. To confirm diagnosis of ADHD, parents will complete the ADHD portion of the MINI-Kid ADHD interview with a trained interviewer, and their child must meet DSM-IV criteria for any Attention Disorder. The researchers will include children who had observable symptoms in two of three settings. As all children will be referred for the study because teachers or staff at their school observed symptoms, the children will have to also meet criteria on the MINI-Kid interview or the trained clinician completing their testing will have to observe notable symptoms, or both, for the child to be included in the study. Exclusion Criteria: Participants will be excluded from the study if they have a diagnosis of bipolar disorder, schizophrenia, or major depression that is currently preventing them from participating in classroom activities. Students with anxiety, mild depression, obsessive-compulsive disorder or other problems that do not prevent them from participating in the majority of classroom activities will not be excluded. Exclusion will be determined through a two-stage process: First, participants will be screened for comorbid symptoms using the Child Behavior Checklist (CBCL). The CBCL for 6-18 year olds has 118 items that describe specific behavioral and emotional problems. Parents rate their child for how true each item is now or within the past 6 months. One of the PIs, both of whom are licensed psychologists with active clinical practices, will follow-up with a child's teacher if a child scores above a T score of 75 on any of the six DSM-oriented scales other than Attention Deficit/Hyperactivity Problems (Affective Problems; Anxiety Problems; Somatic Problems; Oppositional Defiant Problems; and Conduct Problems). The investigators will ask teachers targeted questions to determine to what degree the identified symptoms interfere with the child's ability to participate in the classroom activities or in the treatment group such as "Do you feel that the child can participate in most classroom activities? If not, why? Can they listen to and follow written and verbal instructions? Can they participate in activities with other children when given structure and support?" However, because the school programs involved in this study use an inclusion model, students in these mainstream classrooms are unlikely to meet exclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Kenworthy, Ph.D.
Organizational Affiliation
Children's National Health Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Anthony, Ph.D.
Organizational Affiliation
University of Colorado Anschutz Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Research Institude, Children's National Heath System
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
American Psychiatric Association. Diagnostic and statistical manual of mental disorders, 4th Edition, Text Revision. 2000.
Results Reference
background
Citation
Clopper CJ, Pearson, ES. The use of the confidence or fiducial limits illustrated in the case of the binomial. Biometrika 26(4): 404-413, 1934.
Results Reference
background
Citation
Delis DC, Kaplan E, Kramer JH. Delis Kaplan executive function system (D-KEFS). San Antonio, TX: The Psychological Corporation. 2001.
Results Reference
background
PubMed Identifier
12638065
Citation
Gioia GA, Isquith PK, Kenworthy L, Barton RM. Profiles of everyday executive function in acquired and developmental disorders. Child Neuropsychol. 2002 Jun;8(2):121-37. doi: 10.1076/chin.8.2.121.8727.
Results Reference
background
PubMed Identifier
12759822
Citation
Gioia GA, Isquith PK, Retzlaff PD, Espy KA. Confirmatory factor analysis of the Behavior Rating Inventory of Executive Function (BRIEF) in a clinical sample. Child Neuropsychol. 2002 Dec;8(4):249-57. doi: 10.1076/chin.8.4.249.13513.
Results Reference
background
Citation
Mather N, Wendling BJ. Woodcock-Johnson IV tests of achievement: Examiner manual standard and extended batteries. Rolling Meadows, IL: Houghton Mifflin Harcourt. 2014.
Results Reference
background
PubMed Identifier
23402704
Citation
Weisz JR, Ugueto AM, Cheron DM, Herren J. Evidence-based youth psychotherapy in the mental health ecosystem. J Clin Child Adolesc Psychol. 2013;42(2):274-86. doi: 10.1080/15374416.2013.764824. Epub 2013 Feb 12.
Results Reference
background
PubMed Identifier
11104313
Citation
Wells KC, Pelham WE, Kotkin RA, Hoza B, Abikoff HB, Abramowitz A, Arnold LE, Cantwell DP, Conners CK, Del Carmen R, Elliott G, Greenhill LL, Hechtman L, Hibbs E, Hinshaw SP, Jensen PS, March JS, Swanson JM, Schiller E. Psychosocial treatment strategies in the MTA study: rationale, methods, and critical issues in design and implementation. J Abnorm Child Psychol. 2000 Dec;28(6):483-505. doi: 10.1023/a:1005174913412.
Results Reference
background

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Community Based Intervention for Children With ADHD and ASD

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