Clinical trial NCT05301933: Telehealth BPT in DBP Practice
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 13
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Child must be between the ages of 4-11 years
2. Child must be diagnosed with ADHD (any subtype) within the last 6 months
3. Parent/ legal guardian must be at least 18 years old
4. Parent/ legal guardian must be legal guardian of child
5. Parent/ legal guardian must speak English or Spanish
6. Parent/ legal guardian must not have previously received manualized, multi-session behavioral parent training (BPT)
7. Child must be under public or no insurance
8. Parent/legal guardian must be able to provide consent.

Exclusion Criteria:

1. Children with ADHD who have significant mental health comorbidities that warrant more intensive psychosocial/pharmacological intervention per physician recommendations
2. Parent/ legal guardian who does not have access to reliable internet service to participate in telehealth delivered BPT
3. Parent/ legal guardian with known significant impairment that will be barrier to communication and participation (e.g., intellectual disability, schizophrenia, other significant mental illness)
4. Parent/ legal guardian who has limited, consistent contact with their child (i.e., less than 3 days/week)

Primary outcomes:
measure: Change in IOWA Connors Rating Scale (IOWA-CRS) Score
timeFrame: Baseline, Week 11
measure: Change in Impairment Rating Scale (IRS) Score
timeFrame: Baseline, Week 11
measure: Change in Alabama Parenting Questionnaire- Short Form (APQ-9) Score
timeFrame: Baseline, Week 11
measure: Change in Parental Stress - Short Form (PSI-SF) Total Stress Score
timeFrame: Baseline, Week 11
measure: Change in Barriers to Treatment Participation Scale (BTPS) Score
timeFrame: Baseline, Week 11
measure: Change in Therapy Attitude Inventory (TAI) Score
timeFrame: Baseline, Week 11
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Steinhart Department of Applied Psychology
state: New York
city: New York
country: United States
facility: NYU Langone Health - NYC Health+Hospitals, Bellevue Hospital
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: NYU Langone Health
name: Karen Hopkins, MD
role: PRINCIPAL_INVESTIGATOR
References: