Clinical trial NCT01133847: Interventions for Children With Attention and Reading Disorders
Official title: Reading ICARD: Interventions for Children With Attention and Reading Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Reading Disabilities
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Children's Hospital Medical Center, Cincinnati
First posted: 2010-05-31
Enrollment: 222
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this randomized clinical trial is to address unanswered questions about the relative effectiveness of treatments for children with both Attention Deficit Hyperactivity Disorder (ADHD) and significant reading difficulties (RD). The study evaluates attentional and word reading outcomes for students with both conditions when provided with either (a) ADHD treatment alone, (b) RD treatment alone, or (c) the combination of ADHD and RD treatment.

Detailed description: The objective of this randomized clinical trial is to address unanswered questions about the relative effectiveness of treatments for children with both Attention Deficit Hyperactivity Disorder (ADHD) and significant reading difficulties (RD). The study evaluates attentional and word reading outcomes for students with both conditions when provided with either (a) disorder-specific ADHD treatment (carefully managed medication + parent training), (b) disorder-specific RD treatment (intensive, individualized reading instruction), or (c) the combination of ADHD and RD treatment. The study aims to address the relative benefits of providing either disorder-specific ADHD or RD treatment alone and providing the combined treatment. The investigators hypothesize that the combined treatment approach will result in better outcomes in terms of both word reading/decoding and a reduction in ADHD symptoms than either of the disorder-specific treatments alone. Treatment will last for 16 weeks, with assessment prior to and following treatment and some measures collected regularly throughout the intervention periods.

Eligibility criteria: Inclusion Criteria:

1. Meet criteria for ADHD, Combined Type or ADHD, Predominantly Inattentive Type based on the Diagnostic Interview Schedule for Children, 4.0 (DISC) parent interview, Teacher baseline Swanson Nolan and Pelham Rating Scale (SNAP) endorses additional non-overlapping Inattentive symptoms with the parent DISC, which when combined with the parent ratings result in endorsement of 6 or more symptoms required for diagnosis by the Diagnostic and Statistical Manual.
2. Have at least 4 symptoms of inattention rated "Often" or "Very Often" on the teacher version of the SNAP-IV.
3. Have a standard score of 90 or lower on either the Woodcock-Johnson III Tests of Achievement Letter-Word Identification or Word Attack Subtests, or on the Basic Reading Skills Cluster
4. Attend a participating school in Grades 2-5
5. Have at least one parent or guardian who understands English well enough to participate in the behavioral parent training intervention.
6. Have a Full Scale OR Non-Verbal Intelligence Quotient (IQ) estimate higher than 70 based on the IQ Composite and Non-Verbal IQ estimate of the Kaufman Brief Intelligence Test (KBIT-2).

Exclusion Criteria:

1. Any documented or suspected bipolar disorder, severe psychosis, or other severe emotional disturbance, developmental disability, or autism.
2. Receipt of primary school reading instruction in a language other than English.
3. A history or presence of cardiovascular problems that would contraindicate stimulant treatment.
4. Chronic vocal tics.
5. Children will be excluded if they are taking a concomitant medication that has the potential to significantly affect their ADHD symptoms, that would be contraindicated to take along with the study medication, or if they have not been on a stable dose of a psychotropic medication long enough to fully assess the clinical outcome or tolerability.

Primary outcomes:
measure: Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention
timeFrame: 16 weeks (end of Active Treatment phase), and follow-up
measure: Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity
timeFrame: 16 weeks (end of Active Treatment phase), and follow-up
measure: Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention
timeFrame: Week 16 (End of Active Treatment Phase) and Follow-Up
measure: Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity
timeFrame: Week 16 (End of Active Treatment Phase) and Follow-Up
measure: Wechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest
timeFrame: Week 16 (End of Active Treatment Phase) and Follow-Up
measure: Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest
timeFrame: Week 16 (End of Active Treatment Phase) and Follow-Up
Secondary outcomes:
measure: Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest
timeFrame: Week 16, End of Active Treatment Phase
measure: Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)
timeFrame: Week 16 (End of Active Treatment Phase) and Follow-Up
measure: Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency
timeFrame: Week 16 (End of Active Treatment Phase) and Follow-Up
measure: Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency
timeFrame: Week 16 (End of Active Treatment Phase) and Follow-Up
measure: Test of Silent Reading Fluency and Comprehension (TOSREC)
timeFrame: Week 16, End of Active Treatment Phase
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Carolyn A Denton, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dvorsky M, Tamm L, Denton CA, Epstein JN, Schatschneider C. Trajectories of Response to Treatments in Children with ADHD and Word Reading Difficulties. Res Child Adolesc Psychopathol. 2021 Aug;49(8):1015-1030. doi: 10.1007/s10802-021-00815-y. Epub 2021 Mar 26.