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
  Purpose

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.


Condition Intervention
Attention Deficit Disorder With Hyperactivity
Behavioral: Parent Focused Training (PFT)
Behavioral: Child Life and Attention Skills (CLAS) Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Integrated Multi-setting Psychosocial Treatment for ADHD-Inattentive Type

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 210
Study Start Date: November 2008
Estimated Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will undergo the Child Life and Attention Skills (CLAS) Program.
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.
Active Comparator: 2
Participants will undergo parent focused training (PFT).
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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   7 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00834821

Locations
United States, California
University of California, Berkeley
Berkeley, California, United States, 94720
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
University of California, Berkeley
Investigators
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
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00834821     History of Changes
Other Study ID Numbers: R01 MH077671, R01MH077671, DSIR 84-CTS
Study First Received: February 2, 2009
Last Updated: January 17, 2014
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
Attention Deficit Hyperactivity Disorder
ADHD, Predominantly Inattentive Type
Inattention
Psychosocial Intervention
Behavioral Intervention

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014