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

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent Focused Training (PFT)
Child Life and Attention Skills (CLAS) Program
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring Attention Deficit Hyperactivity Disorder, ADHD, Predominantly Inattentive Type, Inattention, Psychosocial Intervention, Behavioral Intervention

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • University of California, Berkeley
  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

1

2

3

Arm Description

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

Participants will undergo parent focused training (PFT).

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

Outcomes

Primary Outcome Measures

Inattention symptoms, as defined by the DSM-IV

Secondary Outcome Measures

Academic and social functioning

Full Information

First Posted
February 2, 2009
Last Updated
June 14, 2019
Sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH), University of California, Berkeley
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1. Study Identification

Unique Protocol Identification Number
NCT00834821
Brief Title
Effectiveness of a Behavioral Treatment Program for Attention Deficit Hyperactivity Disorder, Inattentive Type
Official Title
Integrated Multi-setting Psychosocial Treatment for ADHD-Inattentive Type
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2008 (Actual)
Primary Completion Date
January 3, 2013 (Actual)
Study Completion Date
January 3, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH), University of California, Berkeley

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
Attention Deficit Hyperactivity Disorder, ADHD, Predominantly Inattentive Type, Inattention, Psychosocial Intervention, Behavioral Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will undergo the Child Life and Attention Skills (CLAS) Program.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will undergo parent focused training (PFT).
Arm Title
3
Arm Type
No Intervention
Arm Description
Participants will receive a list of referrals for clinical services as needed, including professional organizations, support groups, and the community mental health system.
Intervention Type
Behavioral
Intervention Name(s)
Parent Focused Training (PFT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Child Life and Attention Skills (CLAS) Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Academic and social functioning
Time Frame
Measured immediately post-treatment and at a follow-up 5 to 7 months later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda J. Pfiffner, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keith McBurnett, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen P. Hinshaw, PhD
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94720
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

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

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