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Interventions for Children With Attention and Reading Disorders (ICARD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01133847
First Posted: May 31, 2010
Last Update Posted: April 11, 2017
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. Read our disclaimer for details.
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Carolyn Denton, The University of Texas Health Science Center, Houston
Results First Submitted: October 31, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Attention Deficit Hyperactivity Disorder
Reading Disabilities
Interventions: Drug: Methylphenidate
Behavioral: Intensive reading instruction
Behavioral: Parent Training
Drug: Mixed Salt Amphetamine
Drug: Atomoxetine
Drug: Guanfacine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
ADHD Treatment Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
Intensive Reading Instruction Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
Combined ADHD Treatment and Reading Instruction All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.

Participant Flow for 2 periods

Period 1:   Active Treatment Phase (Weeks 1-16)
    ADHD Treatment   Intensive Reading Instruction   Combined ADHD Treatment and Reading Instruction
STARTED   78   74   70 
COMPLETED   73   73   67 
NOT COMPLETED   5   1   3 
Withdrawal by Subject                5                1                3 

Period 2:   Follow-Up Phase
    ADHD Treatment   Intensive Reading Instruction   Combined ADHD Treatment and Reading Instruction
STARTED   73   73   67 
COMPLETED   72   70   60 
NOT COMPLETED   1   3   7 
Lost to Follow-up                1                3                7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics are for our final analysis sample, consisting of all children randomized to each condition except for 1 in the ADHD arm, 1 in the Reading arm, and 4 in the Combined arm, who were excluded because upon ex post-facto review of records, they did not meet either ADHD, RD, or IQ inclusion criteria and had been included in error.

Reporting Groups
  Description
ADHD Treatment Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
Intensive Reading Instruction Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
Combined ADHD Treatment and Reading Instruction All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
Total Total of all reporting groups

Baseline Measures
   ADHD Treatment   Intensive Reading Instruction   Combined ADHD Treatment and Reading Instruction   Total 
Overall Participants Analyzed 
[Units: Participants]
 77   73   66   216 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      77 100.0%      73 100.0%      66 100.0%      216 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      25  32.5%      24  32.9%      35  53.0%      84  38.9% 
Male      52  67.5%      49  67.1%      31  47.0%      132  61.1% 
Region of Enrollment 
[Units: Participants]
       
United States   77   73   66   216 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention   [ Time Frame: 16 weeks (end of Active Treatment phase), and follow-up ]

2.  Primary:   Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity   [ Time Frame: 16 weeks (end of Active Treatment phase), and follow-up ]

3.  Primary:   Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention   [ Time Frame: Week 16 (End of Active Treatment Phase) and Follow-Up ]

4.  Primary:   Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity   [ Time Frame: Week 16 (End of Active Treatment Phase) and Follow-Up ]

5.  Primary:   Wechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest   [ Time Frame: Week 16 (End of Active Treatment Phase) and Follow-Up ]

6.  Primary:   Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest   [ Time Frame: Week 16 (End of Active Treatment Phase) and Follow-Up ]

7.  Secondary:   Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest   [ Time Frame: Week 16, End of Active Treatment Phase ]

8.  Secondary:   Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)   [ Time Frame: Week 16 (End of Active Treatment Phase) and Follow-Up ]

9.  Secondary:   Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency   [ Time Frame: Week 16 (End of Active Treatment Phase) and Follow-Up ]

10.  Secondary:   Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency   [ Time Frame: Week 16 (End of Active Treatment Phase) and Follow-Up ]

11.  Secondary:   Test of Silent Reading Fluency and Comprehension (TOSREC)   [ Time Frame: Week 16, End of Active Treatment Phase ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There was some non-adherence, particularly for the ADHD treatment. Our oversampling of low income, African American children, although valuable in an understudied population, may limit generalizability.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Carolyn Denton
Organization: University of Texas Health Science Center Houston
phone: 713-500-3891
e-mail: carolyn.a.denton@uth.tmc.edu



Responsible Party: Carolyn Denton, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01133847     History of Changes
Other Study ID Numbers: HSC-MS-09-0531
R01HD060617 ( U.S. NIH Grant/Contract )
First Submitted: May 26, 2010
First Posted: May 31, 2010
Results First Submitted: October 31, 2016
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017