Interventions for Children With Attention and Reading Disorders

NCT01133847 | Completed Phase 4 Results DMC

• 2 other identifiers: HSC-MS-09-0531R01HD060617
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 2

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.

Conditions

Attention Deficit Hyperactivity Disorder; Reading Disabilities

Outcome Measures

Primary Outcomes (6)

• Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention

  Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV (Diagnostic and Statistical Manual) ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).

  16 weeks (end of Active Treatment phase), and follow-up

• Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity

  Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV (Diagnostic and Statistical Manual) ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).

  16 weeks (end of Active Treatment phase), and follow-up

• Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention

  Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).

  Week 16 (End of Active Treatment Phase) and Follow-Up

• Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity

  Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).

  Week 16 (End of Active Treatment Phase) and Follow-Up

• Wechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest

  The WIAT-III is an individually-administered test of academic achievement. In the Word Reading subtest students read a list of increasingly difficult words. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15.

  Week 16 (End of Active Treatment Phase) and Follow-Up

• Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest

  The WIAT-III is an individually-administered test of academic achievement. In the Pseudoword Decoding subtest students read a list of increasingly difficult nonsense words as a test of their ability to use phonics to decode unknown words. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15. Higher scores represent a better outcome.

  Week 16 (End of Active Treatment Phase) and Follow-Up

Secondary Outcomes (5)

• Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest

  Week 16, End of Active Treatment Phase

• Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)

  Week 16 (End of Active Treatment Phase) and Follow-Up

• Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency

  Week 16 (End of Active Treatment Phase) and Follow-Up

• Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency

  Week 16 (End of Active Treatment Phase) and Follow-Up

• Test of Silent Reading Fluency and Comprehension (TOSREC)

  Week 16, End of Active Treatment Phase

Study Arms (3)

Intensive Reading Instruction

EXPERIMENTAL

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 weeks. The instructional approach includes an individualized combination of published programs targeting word reading and decoding; reading fluency; and reading comprehension.

Behavioral: Intensive reading instruction

ADHD Intervention

EXPERIMENTAL

Carefully-managed medication and behavioral parent training. Medication treatment begins with a four-week titration period, beginning with a trial of methylphenidate. If benefit is insufficient or side effects are intolerable, the physician may initiate a trial of mixed salt amphetamine, followed by either Atomoxetine or Guanfacine. When the optimum medication and dosage is determined the child returns for monthly medication maintenance visits until the end of the 16-week intervention period. Parent training consists of nine group sessions provided by a psychologist addressing ADHD and its treatment, principals of behavior modification, and evidence-supported practices for managing behavior.

Drug: Methylphenidate; Behavioral: Parent Training; Drug: Mixed Salt Amphetamine; Drug: Atomoxetine; Drug: Guanfacine

Combined ADHD and Reading Instruction

EXPERIMENTAL

All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 weeks. Carefully-managed medication and behavioral parent training. Medication treatment begins with a trial of methylphenidate. If benefit is insufficient or side effects are intolerable, the physician may initiate a trial of mixed salt amphetamine, followed by either Atomoxetine or Guanfacine. When the optimum medication and dosage is determined the child returns for monthly medication maintenance visits until the end of the 16-week intervention period. Parent training consists of nine group sessions on parenting a child with ADHD.

Drug: Methylphenidate; Behavioral: Intensive reading instruction; Behavioral: Parent Training; Drug: Mixed Salt Amphetamine; Drug: Atomoxetine; Drug: Guanfacine

Interventions

Methylphenidate DRUG

Appropriate dosage to be individually determined; daily for 16 weeks

Also known as: Concerta Extended Release, Ritalin

ADHD Intervention; Combined ADHD and Reading Instruction

Intensive reading instruction BEHAVIORAL

Individualized phonologically-based instruction delivered 4 days per week for 45 min. per day by a highly trained tutor.

Combined ADHD and Reading Instruction; Intensive Reading Instruction

Parent Training BEHAVIORAL

Nine sessions on parenting a child with ADHD

ADHD Intervention; Combined ADHD and Reading Instruction

Mixed Salt Amphetamine DRUG

Appropriate dosage to be individually determined; daily for 16 weeks; prescribed only if child does not show a beneficial treatment response to Concerta

Also known as: Adderall Extended Release (XR)

ADHD Intervention; Combined ADHD and Reading Instruction

Atomoxetine DRUG

Appropriate dosage to be individually determined; daily for 16 weeks

Also known as: Strattera

ADHD Intervention; Combined ADHD and Reading Instruction

Guanfacine DRUG

Appropriate dosage to be individually determined; daily for 16 weeks

Also known as: Intuniv

ADHD Intervention; Combined ADHD and Reading Instruction

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Have at least 4 symptoms of inattention rated "Often" or "Very Often" on the teacher version of the SNAP-IV.
• 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
• Attend a participating school in Grades 2-5
• Have at least one parent or guardian who understands English well enough to participate in the behavioral parent training intervention.
• 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).

You may not qualify if:

• Any documented or suspected bipolar disorder, severe psychosis, or other severe emotional disturbance, developmental disability, or autism.
• Receipt of primary school reading instruction in a language other than English.
• A history or presence of cardiovascular problems that would contraindicate stimulant treatment.
• Chronic vocal tics.
• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator

Study Sites (2)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45206, United States

Location

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 33772416 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Dyslexia

Interventions

Methylphenidate; Atomoxetine Hydrochloride; Guanfacine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propylamines; Amines; Guanidines; Amidines

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Carolyn Denton
• Organization: University of Texas Health Science Center Houston

carolyn.a.denton@uth.tmc.edu

713-500-3891

Study Officials

• Carolyn A Denton, Ph.D.

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Pediatrics

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 31, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 11, 2017
• Results First Posted: April 11, 2017

Record last verified: 2017-02

Locations

US (2)