This trial is active, not recruiting.

Condition attention deficit disorder with hyperactivity
Treatments parent focused training (pft), child life and attention skills (clas) program
Sponsor University of California, San Francisco
Collaborator National Institute of Mental Health (NIMH)
Start date November 2008
End date December 2013
Trial size 210 participants
Trial identifier NCT00834821, DSIR 84-CTS, R01 MH077671, R01MH077671


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Participants will undergo the Child Life and Attention Skills (CLAS) Program.
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)
Participants will undergo parent focused training (PFT).
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)
Participants will receive a list of referrals for clinical services as needed, including professional organizations, support groups, and the community mental health system.

Primary Outcomes

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

Secondary Outcomes

Academic and social functioning
time frame: Measured immediately post-treatment and at a follow-up 5 to 7 months later

Eligibility Criteria

Male or female participants from 7 years up to 11 years old.

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

Additional Information

Official title Integrated Multi-setting Psychosocial Treatment for ADHD-Inattentive Type
Principal investigator Linda J. Pfiffner, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by University of California, San Francisco.