ADHDNCT05301933
Telehealth BPT in DBP Practice
A study testing Behavioral Parent Training (BPT) in people with ADHD, run by NYU Langone Health at 3 sites in United States.
Trial summary
Access to evidence-based psychosocial interventions, particularly Behavioral Parent Training (BPT), for youth with Attention Deficit/Hyperactivity Disorder (ADHD) is limited. An approach to increasing such access is to utilize trained paraprofessionals (Family Peer Advocates; FPAs) in the delivery of BPT, particularly… Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- ADHD
- What is being tested?
- Behavioral Parent Training (BPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jul 2022to 11 Sep 2023
- 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 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child must be between the ages of 4-11 years
- Child must be diagnosed with ADHD (any subtype) within the last 6 months
- Parent/ legal guardian must be at least 18 years old
- Parent/ legal guardian must be legal guardian of child
- Parent/ legal guardian must speak English or Spanish
- Parent/ legal guardian must not have previously received manualized, multi-session behavioral parent training (BPT)
- Child must be under public or no insurance
- Parent/legal guardian must be able to provide consent.
Who cannot join
- Children with ADHD who have significant mental health comorbidities that warrant more intensive psychosocial/pharmacological intervention per physician recommendations
- Parent/ legal guardian who does not have access to reliable internet service to participate in telehealth delivered BPT
- Parent/ legal guardian with known significant impairment that will be barrier to communication and participation (e.g., intellectual disability, schizophrenia, other significant mental illness)
- Parent/ legal guardian who has limited, consistent contact with their child (i.e., less than 3 days/week)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
NYU Steinhart Department of Applied Psychology
New York, New York, 10003
NYU Langone Health - NYC Health+Hospitals, Bellevue Hospital
New York, New York, 10016
About this study
Official title: A Pilot Proof of Concept, Multisite, Open Clinical Trial of Telehealth Behavioral Parent Training on Improving Access and Outcomes for Children With ADHD
Access to evidence-based psychosocial interventions, particularly Behavioral Parent Training (BPT), for youth with Attention Deficit/Hyperactivity Disorder (ADHD) is limited. An approach to increasing such access is to utilize trained paraprofessionals (Family Peer Advocates; FPAs) in the delivery of BPT, particularly through modalities, like telehealth, that further improve access and availability. This approach, FPA-delivered BPT via telehealth has yet to be studied. This study will evaluate the benefits of a FPA-delivered BPT for parents of children identified with ADHD in Developmental Behavioral Pediatric (DBPs).
Read the detailed description
There are two aims of the study: Specific Aim 1: To determine the benefits of a FPA-delivered telehealth BPT model on children's ADHD symptoms, oppositional behavior, functional outcomes, parenting behavior and parental stress. Specific Aim 2: Understand the shared decision making process between the parent, physician, and FPA within the Pediatric- Family Peer Advocate (PEDS-FPA) model through qualitative interviews.
- Conditions
- ADHD
- Being tested
- Behavioral Parent Training (BPT)
- 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.
Behavioral Parent Training (BPT)Behavioural
BPT is an evidence-based psychosocial intervention that is directed exclusively to parent of children with ADHD and related disorders. BPT focuses on instructing parents to use approaches to enhance the parent-child relationship (e.g., quality time, praise) and proactive discipline strategies (e.g., time out, reward systems) to reduce challenging child behavior.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Behavioral: Behavioral Parent Training (BPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IOWA Connors Rating Scale (IOWA-CRS) Score
The IOWA-CRS is a widely used brief measure of attention-deficit/hyperactivity disorder and oppositional-defiant behavior in children completed by parents. IOWA-CRS consists of 10 items evaluated using a four-point Likert scale with the following anchors: not at all (0); just a little (1); pretty much (2); and very much (3). The total score range is 10-40; the higher the score, the more concerns with the child's behavior.
Measured: Baseline, Week 11
Change in Impairment Rating Scale (IRS) Score
The IRS measures impairment across domains of functioning, as well as overall need for treatment - consists of 7 items. Parents report on a 7-point scale to signify their child's functioning along a continuum of impairment that ranges from 0 (Not a problem at all. Definitely does not need treatment or special services.) to 6 (Extreme problem. Definitely needs treatment and special services). The total score range is 0-42; the higher the score, the more extreme the challenges and higher the need for intervention.
Measured: Baseline, Week 11
Change in Alabama Parenting Questionnaire- Short Form (APQ-9) Score
APQ-9 is a well-validated 9-item measure of parenting style. Items are rated by the parent scored based on frequency of parenting behavior from Never (1), Almost Never (2), Sometimes (3), Often (4), Always (5). APQ-SF items are based around the three main structures: positive parenting (items 1, 6-7), inconsistent discipline (items 2, 4, 9) and poor supervision (items 3, 5, 8). The score range per structure is 3-27; the higher the score, the more frequent the parenting behavior (e.g., higher scores in positive parenting structure indicates more frequent positive parenting).
Measured: Baseline, Week 11
Change in Parental Stress - Short Form (PSI-SF) Total Stress Score
PSI-SF is a 36-item self-report measure used to assess parenting stress in three domains, Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. The PSI-SF is measured along a 5-point scale with one (Strongly Disagree) to five (Strongly Agree). Higher scores indicate greater levels of parenting stress. For this study, the Total Stress score, which is the sum of the three PSI-SF domains, will be used (total score range = 36-180).
Measured: Baseline, Week 11
Change in Barriers to Treatment Participation Scale (BTPS) Score
BTPS measures barriers to treatment participation involving stressors and obstacles that compete with treatment (e.g., conflict with significant other), treatment demands and issues (e.g., treatment was too confusing), and perceived relevance of treatment (treatment met parent's expectations). BTPS consists of 18 items and is measured along a 5-point scale with 1 (Never a problem) to 5 (Always a problem). The total score range is 18-90; the higher the score, the more barriers to treatment participant.
Measured: Baseline, Week 11
Change in Therapy Attitude Inventory (TAI) Score
TAI is a valid index of consumer satisfaction for participants in BPT. Items are rated on a scale from one (indicating treatment dissatisfaction or lack of improvement) to five (indicating satisfaction with treatment and improvement). Parents will complete this form after the last session of the BPT program. BPT consists of 11 items that are scored on a 5-point Likert scale. The total score range is 11-55; the higher the score, the greater the satisfaction.
Measured: Baseline, Week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Jul 2022
- Primary completion1 Sep 2023
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Hopkins, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301933
- Sponsor's protocol ID
- 21-01458
- Status last verified
- Nov 2023
- First submitted
- 21 Mar 2022
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Proof of Concept, Multisite, Open Clinical Trial of Telehealth Behavioral Parent Training on Improving Access and Outcomes for Children With ADHD
- ClinicalTrials.gov ID
- NCT05301933
- Acronym / sponsor ID
- 21-01458
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 31 Mar 2022 (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.
Access to evidence-based psychosocial interventions, particularly Behavioral Parent Training (BPT), for youth with Attention Deficit/Hyperactivity Disorder (ADHD) is limited. An approach to increasing such access is to utilize trained paraprofessionals (Family Peer Advocates; FPAs) in the delivery of BPT, particularly through modalities, like telehealth, that further improve access and availability. This approach, FPA-delivered BPT via telehealth has yet to be studied. This study will evaluate the benefits of a FPA-delivered BPT for parents of children identified with ADHD in Developmental Behavioral Pediatric (DBPs).
Detailed description
There are two aims of the study: Specific Aim 1: To determine the benefits of a FPA-delivered telehealth BPT model on children's ADHD symptoms, oppositional behavior, functional outcomes, parenting behavior and parental stress. Specific Aim 2: Understand the shared decision making process between the parent, physician, and FPA within the Pediatric- Family Peer Advocate (PEDS-FPA) model through qualitative interviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Behavioral Parent Training (BPT) |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Child must be between the ages of 4-11 years
- Child must be diagnosed with ADHD (any subtype) within the last 6 months
- Parent/ legal guardian must be at least 18 years old
- Parent/ legal guardian must be legal guardian of child
- Parent/ legal guardian must speak English or Spanish
Key exclusion criteria (4 listed)
- Children with ADHD who have significant mental health comorbidities that warrant more intensive psychosocial/pharmacological intervention per physician recommendations
- Parent/ legal guardian who does not have access to reliable internet service to participate in telehealth delivered BPT
- Parent/ legal guardian with known significant impairment that will be barrier to communication and participation (e.g., intellectual disability, schizophrenia, other significant mental illness)
- Parent/ legal guardian who has limited, consistent contact with their child (i.e., less than 3 days/week)
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 |
|---|---|---|
| Behavioral Parent Training (BPT)BPT is an evidence-based psychosocial intervention that is directed exclusively to parent of children with ADHD and related disorders. BPT focuses on instructing parents to use approaches to enhance the parent-child relationship (e.g., quality time, praise) and proactive discipline strategies (e.g., time out, reward systems) to reduce challenging child behavior. | Behavioural | Intervention Group |
Primary outcome
Change in IOWA Connors Rating Scale (IOWA-CRS) Score
Time frame: Baseline, Week 11
The IOWA-CRS is a widely used brief measure of attention-deficit/hyperactivity disorder and oppositional-defiant behavior in children completed by parents. IOWA-CRS consists of 10 items evaluated using a four-point Likert scale with the following anchors: not at all (0); just a little (1); pretty much (2); and very much (3). The total score range is 10-40; the higher the score, the more concerns with the child's behavior.
Change in Impairment Rating Scale (IRS) Score
Time frame: Baseline, Week 11
The IRS measures impairment across domains of functioning, as well as overall need for treatment - consists of 7 items. Parents report on a 7-point scale to signify their child's functioning along a continuum of impairment that ranges from 0 (Not a problem at all. Definitely does not need treatment or special services.) to 6 (Extreme problem. Definitely needs treatment and special services). The total score range is 0-42; the higher the score, the more extreme the challenges and higher the need for intervention.
Change in Alabama Parenting Questionnaire- Short Form (APQ-9) Score
Time frame: Baseline, Week 11
APQ-9 is a well-validated 9-item measure of parenting style. Items are rated by the parent scored based on frequency of parenting behavior from Never (1), Almost Never (2), Sometimes (3), Often (4), Always (5). APQ-SF items are based around the three main structures: positive parenting (items 1, 6-7), inconsistent discipline (items 2, 4, 9) and poor supervision (items 3, 5, 8). The score range per structure is 3-27; the higher the score, the more frequent the parenting behavior (e.g., higher scores in positive parenting structure indicates more frequent positive parenting).
Change in Parental Stress - Short Form (PSI-SF) Total Stress Score
Time frame: Baseline, Week 11
PSI-SF is a 36-item self-report measure used to assess parenting stress in three domains, Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. The PSI-SF is measured along a 5-point scale with one (Strongly Disagree) to five (Strongly Agree). Higher scores indicate greater levels of parenting stress. For this study, the Total Stress score, which is the sum of the three PSI-SF domains, will be used (total score range = 36-180).
Change in Barriers to Treatment Participation Scale (BTPS) Score
Time frame: Baseline, Week 11
BTPS measures barriers to treatment participation involving stressors and obstacles that compete with treatment (e.g., conflict with significant other), treatment demands and issues (e.g., treatment was too confusing), and perceived relevance of treatment (treatment met parent's expectations). BTPS consists of 18 items and is measured along a 5-point scale with 1 (Never a problem) to 5 (Always a problem). The total score range is 18-90; the higher the score, the more barriers to treatment participant.
Change in Therapy Attitude Inventory (TAI) Score
Time frame: Baseline, Week 11
TAI is a valid index of consumer satisfaction for participants in BPT. Items are rated on a scale from one (indicating treatment dissatisfaction or lack of improvement) to five (indicating satisfaction with treatment and improvement). Parents will complete this form after the last session of the BPT program. BPT consists of 11 items that are scored on a 5-point Likert scale. The total score range is 11-55; the higher the score, the greater the satisfaction.
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 Nov 2023.
Related trials for ADHD
Not yet recruitingObservational study
Phase 1: Thrive Together: A Feasibility and Acceptability Evaluation of Peer Mentoring for High Schoolers With ADHD and Their Caregivers
Attention-Deficit/Hyperactivity Disorder (ADHD)
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Active, not recruiting
Parent-Educator Action Response
Attention Deficit and Disruptive Behavior Disorders
RecruitingPhase 3
A Long-term Trial of EB-1020 in Adult Patients With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
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.
Karen Hopkins, MD principal investigator
NYU Langone Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Parent Training (BPT) in people with ADHD, run by NYU Langone Health at 3 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 8 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Change in IOWA Connors Rating Scale (IOWA-CRS) Score (time frame: Baseline, Week 11). The study lists 6 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 18 Nov 2023.