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

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT00834821

Collaborator

National Institute of Mental Health (NIMH) (NIH), University of California, Berkeley (Other)

199

Enrollment

Locations

Arms

50.1

Actual Duration (Months)

99.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Disorder With Hyperactivity	Behavioral: Parent Focused Training (PFT) Behavioral: Child Life and Attention Skills (CLAS) Program	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

199 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Integrated Multi-setting Psychosocial Treatment for ADHD-Inattentive Type

Actual Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Jan 3, 2013

Actual Study Completion Date :

Jan 3, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Inattention symptoms, as defined by the DSM-IV [Measured immediately post-treatment and at a follow-up 5 to 7 months later]

Secondary Outcome Measures

Academic and social functioning [Measured immediately post-treatment and at a follow-up 5 to 7 months later]

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of California, Berkeley	Berkeley	California	United States	94720
2	University of California, San Francisco	San Francisco	California	United States	94143

Sponsors and Collaborators

University of California, San Francisco
National Institute of Mental Health (NIMH)
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