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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of California, Berkeley
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00834821
First received: February 2, 2009
Last updated: January 17, 2014
Last verified: January 2014

February 2, 2009
January 17, 2014
November 2008
December 2013   (final data collection date for primary outcome measure)
Inattention symptoms, as defined by the DSM-IV [ Time Frame: Measured immediately post-treatment and at a follow-up 5 to 7 months later ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00834821 on ClinicalTrials.gov Archive Site
Academic and social functioning [ Time Frame: Measured immediately post-treatment and at a follow-up 5 to 7 months later ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effectiveness of a Behavioral Treatment Program for Attention Deficit Hyperactivity Disorder, Inattentive Type
Integrated Multi-setting Psychosocial Treatment for ADHD-Inattentive Type

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.

Attention deficit hyperactivity disorder (ADHD) is a common childhood disorder in which problems with focusing disrupt a normal life. There are two subtypes of ADHD: combined type (ADHD-C), which includes symptoms of inattention and hyperactivity or impulsivity, and inattentive type (ADHD-I), in which symptoms are limited to inattention. The profile of ADHD-I, including attention deficits, comorbid disorders, social impairments, and neurocognitive functioning, is sufficiently different from the profile of ADHD-C that treatments effective for ADHD-C may not also be effective in treating ADHD-I. Most studies of ADHD treatment evaluate ADHD-C, and there is very little research into treatments aimed specifically at ADHD-I. The Child Life and Attention Skills (CLAS) Program is a behavioral program designed specifically for ADHD-I and combines life skills training for the child, teacher consultation, and parent training techniques adapted from ADHD-C treatments. This study will compare the effectiveness of the CLAS Program, standard parent training, and community referrals in treating children with ADHD-I.

Participation in this study will last 11 to 12 weeks, followed by a 5- to 7-month follow-up period. On the basis of parent and teacher evaluations of each child's behavior, invitations to participate in screening procedures for the study will be extended to children and their parents. There will be two screening visits, during which the child will undergo reviews of medical and developmental history, diagnostic interviews, intelligence testing, academic achievement testing, and neuropsychological testing. The child and parent will be videotaped in a series of interactions, and both will complete questionnaires about child functioning, parent functioning, family functioning, and family relations. The child's teacher and school principal will also be contacted to ensure that they are willing to participate in the study.

Eligible participants will then be randomly assigned to receive the CLAS Program, parent-focused training (PFT), or community referrals. The CLAS Program will involve a half-hour orientation and up to five half-hour weekly meetings with the child's teacher, therapist, and parent over 11 to 12 weeks. The program will also involve ten 1.5-hour group sessions for parents, with separate group sessions for children at the same time, and up to five individual family sessions led by a therapist. Teachers will participate in a school-home note system for maintaining and rewarding child behavior; parents will be taught strategies for giving commands, using rewards and consequences, and establishing routines and organizational schemes; and children will be taught social interaction skills, homework skills, and organizational skills.

Participants in the PFT group will attend the ten 1.5-hour parent group sessions and up to five individual family sessions. Participants in the community referrals group will only receive referrals to community mental health practitioners.

All participants will undergo assessments that are similar to those in the screening visit after completing treatment and again at a follow-up visit 5 to 7 months later. Participants in the CLAS and PFT groups will continue monthly individual family sessions with a therapist until undergoing the follow-up assessment.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Attention Deficit Disorder With Hyperactivity
  • Behavioral: Parent Focused Training (PFT)
    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.
  • Behavioral: Child Life and Attention Skills (CLAS) Program
    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.
  • Experimental: 1
    Participants will undergo the Child Life and Attention Skills (CLAS) Program.
    Intervention: Behavioral: Child Life and Attention Skills (CLAS) Program
  • Active Comparator: 2
    Participants will undergo parent focused training (PFT).
    Intervention: Behavioral: Parent Focused Training (PFT)
  • No Intervention: 3
    Participants will receive a list of referrals for clinical services as needed, including professional organizations, support groups, and the community mental health system.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
210
June 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
7 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00834821
R01 MH077671, R01MH077671, DSIR 84-CTS
No
University of California, San Francisco
University of California, San Francisco
  • National Institute of Mental Health (NIMH)
  • University of California, Berkeley
Principal Investigator: 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
University of California, San Francisco
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP