Effectiveness of a Behavioral Treatment Program for Attention Deficit Hyperactivity Disorder, Inattentive Type

NCT00834821 | Completed

• 2 other identifiers: R01MH077671DSIR 84-CTS
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 2

Brief Summary

This study will test the effectiveness of a new behavioral treatment, called the Child Life and Attention Skills Program, for children with attention deficit hyperactivity disorder, inattentive type.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention Deficit Hyperactivity Disorder; ADHD, Predominantly Inattentive Type; Inattention; Psychosocial Intervention; Behavioral Intervention

Outcome Measures

Primary Outcomes (1)

• Inattention symptoms, as defined by the DSM-IV

  Measured immediately post-treatment and at a follow-up 5 to 7 months later

Secondary Outcomes (1)

• Academic and social functioning

  Measured immediately post-treatment and at a follow-up 5 to 7 months later

Study Arms (3)

1

EXPERIMENTAL

Participants will undergo the Child Life and Attention Skills (CLAS) Program.

Behavioral: Child Life and Attention Skills (CLAS) Program

2

ACTIVE COMPARATOR

Participants will undergo parent focused training (PFT).

Behavioral: Parent Focused Training (PFT)

3

NO INTERVENTION

Participants will receive a list of referrals for clinical services as needed, including professional organizations, support groups, and the community mental health system.

Interventions

Parent Focused Training (PFT) BEHAVIORAL

PFT will involve parenting skills training supplemented with a phone session between a therapist and teacher to cover ADHD, inattentive type. This intervention will include ten 90-minute parent group training sessions and up to five individual sessions with the study therapist.

2

Child Life and Attention Skills (CLAS) Program BEHAVIORAL

CLAS will involve parenting skills training adapted for ADHD, inattentive type; child life skills training; and teacher consultation. This intervention will include ten 90-minute parent group training sessions; ten 90-minute child group training sessions; up to five individual family sessions with the study therapist; and up to six 30-minute sessions with the teacher, parent, and therapist.

1

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Primary DSM-IV diagnosis of attention deficit hyperactivity disorder, inattentive type (ADHD-I)
• IQ score greater than 80
• Living with one biological or adoptive parent for the past year
• Currently attending school full time
• Consent of school to participate in the study

You may not qualify if:

• Current use of nonstimulant psychoactive medication
• Severe visual or hearing impairment
• Severe language delay
• Major neurological illness
• Diagnosis of one of the following: psychosis, bipolar disorder, obsessive-compulsive disorder, pervasive developmental disorder, clinical depression, or suicidality
• Enrolled in all-day special education
• Parent or child does not speak English
• Child or family is currently involved in and expects to continue psychotherapy to address child's attention, behavioral, or emotional problems

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Mental Health (NIMH): collaborator
• University of California, Berkeley: collaborator

Study Sites (2)

University of California, Berkeley

Berkeley, California, 94720, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Linda J. Pfiffner, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Keith McBurnett, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Stephen P. Hinshaw, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 3, 2009
• Study Start: November 1, 2008
• Primary Completion: January 3, 2013
• Study Completion: January 3, 2013
• Last Updated: June 18, 2019

Record last verified: 2019-06

Locations

US (2)