Attention Deficit Disorder With HyperactivityNCT00834821
Effectiveness of a Behavioral Treatment Program for Attention Deficit Hyperactivity Disorder, Inattentive Type
A study testing Parent Focused Training (PFT) and Child Life and Attention Skills (CLAS) Program in people with Attention Deficit Disorder With Hyperactivity, run by University of California, San Francisco at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Parent Focused Training (PFT) and Child Life and Attention Skills (CLAS) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2008to 3 Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, Berkeley
Berkeley, California, 94720
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: 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.
Read the 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.
- Being tested
- Parent Focused Training (PFT), Child Life and Attention Skills (CLAS) Program
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, Predominantly Inattentive Type, Inattention, Psychosocial Intervention, Behavioral Intervention
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Focused Training (PFT)Behavioural
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.
Child Life and Attention Skills (CLAS) ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will undergo the Child Life and Attention Skills (CLAS) Program. Receives: Behavioral: Child Life and Attention Skills (CLAS) Program |
| 2 | Active comparator | Participants will undergo parent focused training (PFT). Receives: Behavioral: Parent Focused Training (PFT) |
| 3 | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inattention symptoms, as defined by the DSM-IV
Measured: Measured immediately post-treatment and at a follow-up 5 to 7 months later
Secondary outcomes (1)
Academic and social functioning
Measured: Measured immediately post-treatment and at a follow-up 5 to 7 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study start1 Nov 2008
- Primary completion3 Jan 2013
- Study completion3 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of California, Berkeley
- Responsible party
- Sponsor
- Investigators
- Linda J. Pfiffner, PhD, Principal investigator, University of California, San FranciscoKeith McBurnett, PhD, Principal investigator, University of California, San FranciscoStephen P. Hinshaw, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834821
- Sponsor's protocol ID
- R01MH077671
- Other IDs
- R01MH077671, DSIR 84-CTS
- Status last verified
- Jun 2019
- First submitted
- 2 Feb 2009
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Multi-setting Psychosocial Treatment for ADHD-Inattentive Type
- ClinicalTrials.gov ID
- NCT00834821
- Acronym / sponsor ID
- R01MH077671
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, Predominantly Inattentive Type, Inattention, Psychosocial Intervention, Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of California, Berkeley
- Study start
- 1 Nov 2008 (actual)
- Primary completion
- 3 Jan 2013 (actual)
- Study completion
- 3 Jan 2013 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Child Life and Attention Skills (CLAS) ProgramParticipants will undergo the Child Life and Attention Skills (CLAS) Program. |
| 2 | Active comparator | Behavioral: Parent Focused Training (PFT)Participants will undergo parent focused training (PFT). |
| 3 | 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. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | 2 |
| Child Life and Attention Skills (CLAS) ProgramCLAS 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. | Behavioural | 1 |
Primary outcome
Inattention symptoms, as defined by the DSM-IV
Time frame: Measured immediately post-treatment and at a follow-up 5 to 7 months later
1 secondary outcome
Academic and social functioning
Time frame: Measured immediately post-treatment and at a follow-up 5 to 7 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda J. Pfiffner, PhD principal investigator
University of California, San Francisco
Keith McBurnett, PhD principal investigator
University of California, San Francisco
Stephen P. Hinshaw, PhD principal investigator
University of California, Berkeley
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Focused Training (PFT) and Child Life and Attention Skills (CLAS) Program in people with Attention Deficit Disorder With Hyperactivity, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.