ADHDSPBTNCT02824796
Group Training for Parents Whose Children Suffer From ADHD and Comorbidity Using a Behavioral-Dynamic Approach
A study testing Schema Parent Behavioral Training and Parent Behavioral Training in people with ADHD, run by Assuta Hospital Systems at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether a new parent training protocol for children with Attention Deficit Hyperactivity Disorder (ADHD) can over perform the state of the art Parent Training protocol (PBT) by increasing the long term effectiveness of the treatment, reducing the dropout rate and reducing the… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- ADHD
- What is being tested?
- Schema Parent Behavioral Training and Parent Behavioral Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Mar 2016to 19 Dec 2019
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents to children 6-12 with ADHD symptoms according to the criteria of Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM-V)
- The child was diagnosed in the past as ADHD by MD
Who cannot join
- Parents with psychotic symptoms or suicidality
- Parents with active manic episode
- Parents with substance dependence
- Parents with autism spectrum disorder
Trial locations and contacts
1 site in 1 country.
Israel1 site
Mental Health Children and Adolescent Clinic, Maccabi Health Services
Netanya, 42311
About this study
Official title: Group Training for Parents Whose Children Suffer From ADHD and Comorbidity Using a Behavioral-Dynamic Approach: A Randomized Controlled Trial
The purpose of this study is to determine whether a new parent training protocol for children with Attention Deficit Hyperactivity Disorder (ADHD) can over perform the state of the art Parent Training protocol (PBT) by increasing the long term effectiveness of the treatment, reducing the dropout rate and reducing the comorbidities.
- Conditions
- ADHD
- Being tested
- Schema Parent Behavioral Training, Parent Behavioral Training
- Keywords
- ADHD
- 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.
Schema Parent Behavioral TrainingBehavioural
A novel protocol for parent whose children suffer from ADHD and comorbidities. The protocol combines elements from Schema Focus Therapy (SFT) and Parent Behavioral Training (PBT)
Parent Behavioral TrainingBehavioural
A state of the art Parent Behavioral Treatment (PBT) for Children who suffer from ADHD symptoms
| Study group | Role | What they receive |
|---|---|---|
| Schema Parent Behavioral Training | Experimental | An enhanced protocol which combines a Schema Focused Therapy (SFT) and Behavioral Parent Training (PBT) Receives: Behavioral: Schema Parent Behavioral Training |
| Parent Behavioral Training | Active comparator | Usually medication \& The usual PBT treatment Receives: Behavioral: Parent Behavioral Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in parent-teacher-rated ADHD symptoms
The Child Behavior Checklist (CBCL)-Attention Problem Scale (Child Behavior Checklist)
Measured: baseline, 12 weeks, 25 weeks, 3 months, 6 months, 12 months
Secondary outcomes (2)
Dropout rate
Group dropout rate during treatment
Measured: baseline, 12 weeks, 25 weeks
Change from baseline in parent-teacher-rated Comorbidities symptoms
CBCL Internalizing score (Child Behavior Checklist)
Measured: baseline, 25 weeks, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start9 Mar 2016
- Primary completion19 Dec 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Hospital Systems
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824796
- Sponsor's protocol ID
- 2015096
- Acronym
- SPBT
- Status last verified
- Jan 2020
- First submitted
- 29 Jun 2016
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lee PC, Niew WI, Yang HJ, Chen VC, Lin KC. A meta-analysis of behavioral parent training for children with attention deficit hyperactivity disorder. Res Dev Disabil. 2012 Nov-Dec;33(6):2040-9. doi: 10.1016/j.ridd.2012.05.011. Epub 2012 Jun 29.
PubMed 22750360Solan M, Brunstein Klomek A, Ankori G, Bloch A, Apter A, Plishty S. Impact of a New Parent Behavioral-Schema Training on Children with ADHD: A Pragmatic Control Trial. J Atten Disord. 2021 Dec;25(14):2048-2059. doi: 10.1177/1087054720959711. Epub 2020 Sep 30.
PubMed 32996352
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Training for Parents Whose Children Suffer From ADHD and Comorbidity Using a Behavioral-Dynamic Approach: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02824796
- Acronym / sponsor ID
- SPBT / 2015096
- Conditions
- ADHD
- Keywords
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Assuta Hospital SystemsUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- 9 Mar 2016 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 7 Jul 2016 (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.
The purpose of this study is to determine whether a new parent training protocol for children with Attention Deficit Hyperactivity Disorder (ADHD) can over perform the state of the art Parent Training protocol (PBT) by increasing the long term effectiveness of the treatment, reducing the dropout rate and reducing the comorbidities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Schema Parent Behavioral Training | Experimental | Behavioral: Schema Parent Behavioral TrainingAn enhanced protocol which combines a Schema Focused Therapy (SFT) and Behavioral Parent Training (PBT) |
| Parent Behavioral Training | Active comparator | Behavioral: Parent Behavioral TrainingUsually medication \& The usual PBT treatment |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Parents to children 6-12 with ADHD symptoms according to the criteria of Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM-V)
- The child was diagnosed in the past as ADHD by MD
Key exclusion criteria (4 listed)
- Parents with psychotic symptoms or suicidality
- Parents with active manic episode
- Parents with substance dependence
- Parents with autism spectrum disorder
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 |
|---|---|---|
| Schema Parent Behavioral TrainingA novel protocol for parent whose children suffer from ADHD and comorbidities. The protocol combines elements from Schema Focus Therapy (SFT) and Parent Behavioral Training (PBT) | Behavioural | Schema Parent Behavioral Training |
| Parent Behavioral TrainingA state of the art Parent Behavioral Treatment (PBT) for Children who suffer from ADHD symptoms | Behavioural | Parent Behavioral Training |
Primary outcome
Change from baseline in parent-teacher-rated ADHD symptoms
Time frame: baseline, 12 weeks, 25 weeks, 3 months, 6 months, 12 months
The Child Behavior Checklist (CBCL)-Attention Problem Scale (Child Behavior Checklist)
2 secondary outcomes
Dropout rate
Time frame: baseline, 12 weeks, 25 weeks
Change from baseline in parent-teacher-rated Comorbidities symptoms
Time frame: baseline, 25 weeks, 3 months, 6 months, 12 months
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 25 Nov 2020.
- Background: PubMed 22750360Lee PC, Niew WI, Yang HJ, Chen VC, Lin KC. A meta-analysis of behavioral parent training for children with attention deficit hyperactivity disorder. Res Dev Disabil. 2012 Nov-Dec;33(6):2040-9. doi: 10.1016/j.ridd.2012.05.011. Epub 2012 Jun 29.
- Derived from this study: PubMed 32996352Solan M, Brunstein Klomek A, Ankori G, Bloch A, Apter A, Plishty S. Impact of a New Parent Behavioral-Schema Training on Children with ADHD: A Pragmatic Control Trial. J Atten Disord. 2021 Dec;25(14):2048-2059. doi: 10.1177/1087054720959711. Epub 2020 Sep 30.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schema Parent Behavioral Training and Parent Behavioral Training in people with ADHD, run by Assuta Hospital Systems at 1 site in Israel.
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 2 inclusion and 4 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 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Change from baseline in parent-teacher-rated ADHD symptoms (time frame: baseline, 12 weeks, 25 weeks, 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02824796, which also lists 2 linked publications.
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 25 Nov 2020.