ClinicalTrials.gg
CompletedNCT02824796SPBTUpdated Nov 25, 2020

Group Training for Parents Whose Children Suffer From ADHD and Comorbidity Using a Behavioral-Dynamic Approach

An interventional study of Schema Parent Behavioral Training and Parent Behavioral Training in ADHD, sponsored by Assuta Hospital Systems. Completed at 1 site in Israel. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2020-11-25.

Sponsored by Assuta Hospital Systems · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Mar 2016, registered Jun 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
83
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
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Study 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 comorbidities.

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Conditions studied

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In context

Attention Deficit Disorder with Hyperactivity

1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.

This study's enrollment of 83 is above the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Assuta Hospital Systems is the lead sponsor of 34 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Parents to children 6-12 with ADHD symptoms according to the criteria of - 5th edition (DSM-V)
  • The child was diagnosed in the past as ADHD by MD

Exclusion criteria

Exclusion Criteria:

  • Parents with psychotic symptoms or suicidality
  • Parents with active manic episode
  • Parents with substance dependence
  • Parents with autism spectrum disorder
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
83 participants (actual)

Study arms

  • Experimental
    Schema Parent Behavioral Training

    An enhanced protocol which combines a Schema Focused Therapy (SFT) and Behavioral Parent Training (PBT)

    Behavioral: Schema Parent Behavioral Training

  • Active comparator
    Parent Behavioral Training

    Usually medication \& The usual PBT treatment

    Behavioral: Parent Behavioral Training

Interventions

  • BehavioralSchema Parent Behavioral Training

    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)

  • BehavioralParent Behavioral Training

    A state of the art Parent Behavioral Treatment (PBT) for Children who suffer from ADHD symptoms

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What researchers measure

Primary outcomes

  1. Change from baseline in parent-teacher-rated ADHD symptoms

    The Child Behavior Checklist (CBCL)-Attention Problem Scale (Child Behavior Checklist)

    Time frame: baseline, 12 weeks, 25 weeks, 3 months, 6 months, 12 months

Secondary outcomes

  1. Dropout rate

    Group dropout rate during treatment

    Time frame: baseline, 12 weeks, 25 weeks

  2. Change from baseline in parent-teacher-rated Comorbidities symptoms

    CBCL Internalizing score (Child Behavior Checklist)

    Time frame: baseline, 25 weeks, 3 months, 6 months, 12 months

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Study locations

1 site
  • Mental Health Children and Adolescent Clinic, Maccabi Health Services
    Netanya, 42311, Israel
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References and documents

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 22750360 ↗
  • Solan 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 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2016 to primary completion in Dec 2019, 45 months.

Of 479 non-industry interventional studies with no phase under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 45 months is above that.

Counting every sponsor, half of 510 studies reached it within 23 months; a quarter within 11 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2016
First posted
Jul 7, 2016
StartActual
Mar 9, 2016
Primary completionActual
Dec 19, 2019
CompletionActual
Dec 19, 2019
Last update
Nov 25, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02824796
Lead sponsor
Assuta Hospital Systems
Collaborators
Tel Aviv University
Responsible party
Sponsor
First posted
Jul 7, 2016
Start date
Mar 9, 2016
Primary completion
Dec 19, 2019
Completion
Dec 19, 2019
Last update
Nov 25, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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