Child BehaviorNCT04121650
Executive Function and Symptom Reduction in Youth Receiving Home-based Treatment With Collaborative Problem Solving
An observational study of Child Behavior and Problem Behavior, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
In this project, the investigators will extend prior results of parent-reported executive function growth and symptom reduction in children receiving home-based treatment with the Collaborative Problem Solving treatment approach (CPS), with a particular focus on examining children who have attention deficit… Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Child Behavior, Problem Behavior, Executive Dysfunction
- What is being tested?
- Collaborative Problem Solving
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2019to 1 Jul 2022
- Phase
- Observational
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Study population: The participants of this study are youth (ages 7 to 14) who are the identified clients being seen in home-based therapy at identified Youth Villages sites in Massachusetts.
Who may be able to join
- Clients of participating non-profit organization that are receiving home-based youth mental health care
- Speaking and writing English at level necessary to complete study requirements
Who cannot join
- Youth is in full state custody and consent cannot be obtained by a guardian
- Youth and/or guardians do not speak English well enough to complete standardized measures
- Youth has a confirmed or suspected Full Scale IQ below 70, or carries a prior diagnosis of Autism Spectrum Disorder at the moderate or severe level
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Executive Functions and Symptom Reduction in Youth Receiving Home-based Treatment With Collaborative Problem Solving
In this project, the investigators will extend prior results of parent-reported executive function growth and symptom reduction in children receiving home-based treatment with the Collaborative Problem Solving treatment approach (CPS), with a particular focus on examining children who have attention deficit hyperactivity disorder (ADHD). The investigators will examine executive functioning (EF) of children who are receiving CPS, measuring EF with parent-report and objective computer-based tasks, at two timepoints: at the start of treatment and approximately four months later, and will collect symptoms at these plus three additional timepoints: at discharge, 6-months after discharge, and 12-months after discharge.
- Conditions
- Child Behavior, Problem Behavior, Executive Dysfunction
- Being tested
- Collaborative Problem Solving
- Keywords
- Executive Functioning, ADHD, Behavior Problems, Youth, CPS, Collaborative Problem Solving, Disruptive Behavior, Parenting
- Medical subject headings
- Child Behavior, Problem Behavior, Attention Deficit Disorder with Hyperactivity, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Problem SolvingBehavioural
Also called CPS
CPS is an approach for understanding and reducing challenging behavior in youth. Under CPS, caregivers are taught to understand and identify the specific neurocognitive skill deficits that underlie their child's challenging behavior. Then the caregivers are taught to interact with the child in a way that solves chronic behavior problems while building the lagging neurocognitive skills to avoid future problems.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Behavioral Symptoms
Strengths and Difficulties Questionnaire (Parent-report measuring child emotional problems, conduct issues, hyperactivity/inattention, peer relationship problems, and pro- social behavior)
Measured: Baseline, 4 months, discharge, 6 months post-discharge, and 12 months post-discharge
Change in Behavioral Symptoms
Clinical Global Impressions (Measures clients' symptom severity, global improvement, and therapeutic response)
Measured: Baseline, 4 months, and discharge
Change in Executive Functioning Skills
Behavior Rating Inventory of Executive Functioning (Parent-report measuring deficits in different domains of executive functioning)
Measured: Baseline and 4 months
Change in Executive Functioning Skills
CANTAB computer-based cognitive tasks (Motor Screening Task, Stop Signal Task, Spatial Span, Multitasking Test, Stockings of Cambridge, Intra-Extra Dimensional Set Shift)
Measured: Baseline and 4 months
Secondary outcomes (2)
Change in Child-Parent Relationship
Child-Parent Relationship Scale (A 15-question measure of parents perceptions of their relationship with their child by using a scale of 1-5 where 1 "definitely does not apply" and a 5 "definitely applies to the child-parent relationship")
Measured: Baseline and 4 months
Treatment providers' fidelity to Collaborative Problem Solving (as a moderator)
CPS Treatment Integrity Rating Form Short (Observational ratings by trained CPS coaches that quantitatively measure providers' fidelity to the practice of the CPS treatment approach)
Measured: provider rating made closest in proximity to four-month timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start14 Oct 2019
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gerstner Philanthropies, Youth Villages
- Responsible party
- Principal investigator, Alisha R Pollastri, Massachusetts General Hospital
- Investigators
- Alisha R Pollastri, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121650
- Sponsor's protocol ID
- 2019P002239
- Status last verified
- Jun 2026
- First submitted
- 7 Oct 2019
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Functions and Symptom Reduction in Youth Receiving Home-based Treatment With Collaborative Problem Solving
- ClinicalTrials.gov ID
- NCT04121650
- Acronym / sponsor ID
- 2019P002239
- Conditions
- Child Behavior, Problem Behavior, Executive Dysfunction
- Keywords
- Executive Functioning, ADHD, Behavior Problems, Youth, CPS, Collaborative Problem Solving, Disruptive Behavior, Parenting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Gerstner Philanthropies, Youth Villages
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 10 Oct 2019 (actual)
- 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.
In this project, the investigators will extend prior results of parent-reported executive function growth and symptom reduction in children receiving home-based treatment with the Collaborative Problem Solving treatment approach (CPS), with a particular focus on examining children who have attention deficit hyperactivity disorder (ADHD). The investigators will examine executive functioning (EF) of children who are receiving CPS, measuring EF with parent-report and objective computer-based tasks, at two timepoints: at the start of treatment and approximately four months later, and will collect symptoms at these plus three additional timepoints: at discharge, 6-months after discharge, and 12-months after discharge.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The participants of this study are youth (ages 7 to 14) who are the identified clients being seen in home-based therapy at identified Youth Villages sites in Massachusetts.
Key inclusion criteria (2 listed)
- Clients of participating non-profit organization that are receiving home-based youth mental health care
- Speaking and writing English at level necessary to complete study requirements
Key exclusion criteria (3 listed)
- Youth is in full state custody and consent cannot be obtained by a guardian
- Youth and/or guardians do not speak English well enough to complete standardized measures
- Youth has a confirmed or suspected Full Scale IQ below 70, or carries a prior diagnosis of Autism Spectrum Disorder at the moderate or severe level
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 |
|---|---|---|
| Collaborative Problem SolvingAlso: CPSCPS is an approach for understanding and reducing challenging behavior in youth. Under CPS, caregivers are taught to understand and identify the specific neurocognitive skill deficits that underlie their child's challenging behavior. Then the caregivers are taught to interact with the child in a way that solves chronic behavior problems while building the lagging neurocognitive skills to avoid future problems. | Behavioural | – |
Primary outcome
Change in Behavioral Symptoms
Time frame: Baseline, 4 months, discharge, 6 months post-discharge, and 12 months post-discharge
Strengths and Difficulties Questionnaire (Parent-report measuring child emotional problems, conduct issues, hyperactivity/inattention, peer relationship problems, and pro- social behavior)
Change in Behavioral Symptoms
Time frame: Baseline, 4 months, and discharge
Clinical Global Impressions (Measures clients' symptom severity, global improvement, and therapeutic response)
Change in Executive Functioning Skills
Time frame: Baseline and 4 months
Behavior Rating Inventory of Executive Functioning (Parent-report measuring deficits in different domains of executive functioning)
Change in Executive Functioning Skills
Time frame: Baseline and 4 months
CANTAB computer-based cognitive tasks (Motor Screening Task, Stop Signal Task, Spatial Span, Multitasking Test, Stockings of Cambridge, Intra-Extra Dimensional Set Shift)
2 secondary outcomes
Change in Child-Parent Relationship
Time frame: Baseline and 4 months
Treatment providers' fidelity to Collaborative Problem Solving (as a moderator)
Time frame: provider rating made closest in proximity to four-month timepoint
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 15 Jun 2026.
Related trials for Child Behavior
Active, not recruiting
A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers
Healthy, 24-Hour Movement Guidelines
Recruiting
Online Feeding Education for Fathers of Children With Feeding Problems
Feeding Problems, Parent Training
Recruiting
Family Connections
Emotional Disturbance, Behavior Disorders in Children
Not yet recruitingObservational study
Child Behavior Ratings During Dental Treatment
Child, Behaviour
Not yet recruiting
Gamified Versus Regular Exercise Snacks on Stationary Bikes, as One 10-Minute or Two 5-Minute Sessions a Day, for Children in an Inclusive Primary School
Exercise, Sedentary Behavior
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.
Alisha R Pollastri, Ph.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Behavior and Problem Behavior, run by Massachusetts General Hospital at 1 site 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 2 inclusion and 3 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 15 Jun 2026. 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 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?
Change in Behavioral Symptoms (time frame: Baseline, 4 months, discharge, 6 months post-discharge, and 12 months post-discharge). The study lists 4 primary outcomes in all. 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 15 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.