Child Behavior Problem Clinical Trial
— SKIPforPAOfficial title:
Care Team and Practice Level Implementation Strategies to Optimize Pediatric Collaborative Care: A Cluster-Randomized Trial
In a prior application (MH064372), the investigators' treatment research program (Services for Kids In Primary-care, SKIP) developed and tested a chronic care model-based intervention, called Doctor Office Collaborative Care (DOCC), that was found to be effective in the management of childhood behavior problems and comorbid ADHD. In the "SKIP for PA Study", the investigators propose to conduct a randomized clinical trial to evaluate the effects of team- and practice leadership-level implementation strategies designed to enhance the use and uptake of DOCC in diverse pediatric primary care offices.
Status | Recruiting |
Enrollment | 450 |
Est. completion date | July 2026 |
Est. primary completion date | July 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | The investigators propose to recruit 4 types of practice provider participants (PCP = primary care provider, CM = care manager, SL = Senior Leader, PM = practice manager) as well as caregiver participants. Inclusion Criteria: - PCP Participants: - Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team. - Identified by the practice as a Primary Care Provider - CM Participants: - Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team. - Identified by the practice as a Behavioral Health Resource who delivers and coordinates behavioral health care in the practice, who will function in the study as a care manager. - SL Participants: - Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team. - Identified by the practice as the Senior Leader. - Have a practice-level leadership role such as Medical Director or a clinical/practice leader - Have administrative responsibilities related to patient care and/or the operations/management of the practice - PM Participants: - Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team. - Identified by the practice as the Practice Manager or equivalent position - Are responsible for day-to-day practice operations, such as personnel management, billing, and compliance with regulations, in the pediatric practice. - Caregiver Participants: - Have a child age 5-12 years old who exhibits at least a modest level of behavior problems (Caregiver Participants) - Are at least 18 years of age (Caregiver participants) - Have parental rights for this child (Caregiver participants) Exclusion Criteria: - Caregivers - Already enrolled in the study as the caregiver to a different child (e.g., sibling) (Caregiver participants) |
Country | Name | City | State |
---|---|---|---|
United States | Drexel University | Philadelphia | Pennsylvania |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | American Academy of Pediatrics, Drexel University, National Institute of Mental Health (NIMH), NYU Langone Health, Pennsylvania Chapter American Academy of Pediatrics, University of Michigan |
United States,
Kolko DJ, Campo J, Kilbourne AM, Hart J, Sakolsky D, Wisniewski S. Collaborative care outcomes for pediatric behavioral health problems: a cluster randomized trial. Pediatrics. 2014 Apr;133(4):e981-92. doi: 10.1542/peds.2013-2516. Epub 2014 Mar 24. — View Citation
Kolko DJ, Campo JV, Kelleher K, Cheng Y. Improving access to care and clinical outcome for pediatric behavioral problems: a randomized trial of a nurse-administered intervention in primary care. J Dev Behav Pediatr. 2010 Jun;31(5):393-404. doi: 10.1097/DBP.0b013e3181dff307. — View Citation
Kolko DJ, Campo JV, Kilbourne AM, Kelleher K. Doctor-office collaborative care for pediatric behavioral problems: a preliminary clinical trial. Arch Pediatr Adolesc Med. 2012 Mar;166(3):224-31. doi: 10.1001/archpediatrics.2011.201. Epub 2011 Nov 7. — View Citation
Kolko DJ, Hart JA, Campo J, Sakolsky D, Rounds J, Wolraich ML, Wisniewski SR. Effects of Collaborative Care for Comorbid Attention Deficit Hyperactivity Disorder Among Children With Behavior Problems in Pediatric Primary Care. Clin Pediatr (Phila). 2020 Jul;59(8):787-800. doi: 10.1177/0009922820920013. — View Citation
Kolko DJ, McGuier EA, Turchi R, Thompson E, Iyengar S, Smith SN, Hoagwood K, Liebrecht C, Bennett IM, Powell BJ, Kelleher K, Silva M, Kilbourne AM. Care team and practice-level implementation strategies to optimize pediatric collaborative care: study protocol for a cluster-randomized hybrid type III trial. Implement Sci. 2022 Feb 22;17(1):20. doi: 10.1186/s13012-022-01195-7. — View Citation
McGuier EA, Kolko DJ, Klem ML, Feldman J, Kinkler G, Diabes MA, Weingart LR, Wolk CB. Team functioning and implementation of innovations in healthcare and human service settings: a systematic review protocol. Syst Rev. 2021 Jun 26;10(1):189. doi: 10.1186/s13643-021-01747-w. — View Citation
McGuier EA, Kolko DJ, Ramsook KA, Huh AS, Berkout OV, Campo JV. Effects of Primary Care Provider Characteristics on Changes in Behavioral Health Delivery During a Collaborative Care Trial. Acad Pediatr. 2020 Apr;20(3):399-404. doi: 10.1016/j.acap.2019.11.008. Epub 2019 Nov 21. — View Citation
Yu H, Kolko DJ, Torres E. Collaborative mental health care for pediatric behavior disorders in primary care: Does it reduce mental health care costs? Fam Syst Health. 2017 Mar;35(1):46-57. doi: 10.1037/fsh0000251. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total number of DOCC encounters | As part of a short checklist-style progress note completed after each service contact and housed in the study's web-based patient registry dashboard, providers will document each DOCC encounter delivered to each family. These encounters include referral, assessment, treatment or medication delivery, medication or treatment review/monitoring, case management, review of emergent symptoms, and care management and consultation meetings involving a family member. Investigators will report the total number of DOCC encounters delivered to each family during the intervention phase. | Throughout services after each contact, up to 12 months | |
Primary | Care management competencies and functions | The Mental Health Practice Readiness Inventory will be completed to document the degree to which a practice has the organizational and individual competencies needed to support integrated BH care. All 32 items reflect the diverse activities (e.g., workflows, financing, service delivery, care coordination) suggested as functions for PCPs (scale: 0 = no function exists; 1 = some function; 2 = function is complete). Thus, total scale scores can range from 0 to 64. Investigators will use scores for each of the 32 competency items (range 0-2) and the total score (range 0-64) to describe the overall level of collaborative care competencies achieved per practice. | At provider baseline | |
Primary | Change from baseline in care management competencies and functions at 6 months | The Mental Health Practice Readiness Inventory will be completed to document the degree to which a practice has the organizational and individual competencies needed to support integrated BH care. All 32 items reflect the diverse activities (e.g., workflows, financing, service delivery, care coordination) suggested as functions for PCPs (scale: 0 = no function exists; 1 = some function; 2 = function is complete). Thus, total scale scores can range from 0 to 64. Investigators will use scores for each of the 32 competency items (range 0-2) and the total score (range 0-64) to describe the overall level of collaborative care competencies achieved per practice. | 6 months after provider baseline | |
Primary | Change from baseline in care management competencies and functions at 12 months | The Mental Health Practice Readiness Inventory will be completed to document the degree to which a practice has the organizational and individual competencies needed to support integrated BH care. All 32 items reflect the diverse activities (e.g., workflows, financing, service delivery, care coordination) suggested as functions for PCPs (scale: 0 = no function exists; 1 = some function; 2 = function is complete). Thus, total scale scores can range from 0 to 64. Investigators will use scores for each of the 32 competency items (range 0-2) and the total score (range 0-64) to describe the overall level of collaborative care competencies achieved per practice. | 12 months after provider baseline | |
Primary | Change from baseline in care management competencies and functions at 18 months | The Mental Health Practice Readiness Inventory will be completed to document the degree to which a practice has the organizational and individual competencies needed to support integrated BH care. All 32 items reflect the diverse activities (e.g., workflows, financing, service delivery, care coordination) suggested as functions for PCPs (scale: 0 = no function exists; 1 = some function; 2 = function is complete). Thus, total scale scores can range from 0 to 64. Investigators will use scores for each of the 32 competency items (range 0-2) and the total score (range 0-64) to describe the overall level of collaborative care competencies achieved per practice. | 18 months after provider baseline | |
Primary | Change from baseline in care management competencies and functions at 24 months | The Mental Health Practice Readiness Inventory will be completed to document the degree to which a practice has the organizational and individual competencies needed to support integrated BH care. All 32 items reflect the diverse activities (e.g., workflows, financing, service delivery, care coordination) suggested as functions for PCPs (scale: 0 = no function exists; 1 = some function; 2 = function is complete). Thus, total scale scores can range from 0 to 64. Investigators will use scores for each of the 32 competency items (range 0-2) and the total score (range 0-64) to describe the overall level of collaborative care competencies achieved per practice. | 24 months after provider baseline | |
Primary | Severity of ADHD, ODD, CD, and ANX/DEP symptoms at home and in community | To assess the severity of the child's behavioral and emotional problems, the Vanderbilt ADHD Diagnostic Rating Scale will be completed by caregivers. The VADPRS includes 5 symptom severity subscales, each with a varying number of items: (hyperactivity/impulsivity (n=9), inattention (n=9), oppositional behavior (n=7), conduct problems (n=15), and anxiety/depression (n=7). The scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance (impairment) subscale (n=7) used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional behavior (21), conduct problems (45), anxiety/depression (21) ,and performance (24). | At caregiver baseline | |
Primary | Change from baseline in severity of ADHD, ODD, CD, and ANX/DEP symptoms at home and in community at 3 months | To assess the severity of the child's behavioral and emotional problems, the Vanderbilt ADHD Diagnostic Rating Scale will be completed by caregivers. The VADPRS includes 5 symptom severity subscales, each with a varying number of items: (hyperactivity/impulsivity (n=9), inattention (n=9), oppositional behavior (n=7), conduct problems (n=15), and anxiety/depression (n=7). The scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance (impairment) subscale (n=7) used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional behavior (21), conduct problems (45), anxiety/depression (21) ,and performance (24). | 3 months after caregiver baseline | |
Primary | Change from baseline in severity of ADHD, ODD, CD, and ANX/DEP symptoms at home and in community at 6 months | To assess the severity of the child's behavioral and emotional problems, the Vanderbilt ADHD Diagnostic Rating Scale will be completed by caregivers. The VADPRS includes 5 symptom severity subscales, each with a varying number of items: (hyperactivity/impulsivity (n=9), inattention (n=9), oppositional behavior (n=7), conduct problems (n=15), and anxiety/depression (n=7). The scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance (impairment) subscale (n=7) used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional behavior (21), conduct problems (45), anxiety/depression (21) ,and performance (24). | 6 months after caregiver baseline | |
Primary | Change from baseline in severity of ADHD, ODD, CD, and ANX/DEP symptoms at home and in community at 12 months | To assess the severity of the child's behavioral and emotional problems, the Vanderbilt ADHD Diagnostic Rating Scale will be completed by caregivers. The VADPRS includes 5 symptom severity subscales, each with a varying number of items: (hyperactivity/impulsivity (n=9), inattention (n=9), oppositional behavior (n=7), conduct problems (n=15), and anxiety/depression (n=7). The scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance (impairment) subscale (n=7) used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional behavior (21), conduct problems (45), anxiety/depression (21) ,and performance (24). | 12 months after caregiver baseline | |
Primary | Severity of ADHD, ODD/CD, and ANX/DEP symptoms at school | Paralleling the VADPRS, the VADTRS will be completed by teachers. This version includes 3 of the same subscales in the parent version -- hyperactivity/impulsivity (n=9), inattention (n=9), and anxiety/depression (n=7) -- but it also includes an aggregated oppositional/conduct scale (n=10 items). Scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance subscale (n=8 items) that is used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional/conduct problems (30), anxiety/depression (21) ,and performance (24). Practices will continue to separately request their own forms during services (e.g., for medication monitoring). | At teacher baseline | |
Primary | Change from baseline in severity of ADHD, ODD/CD, and ANX/DEP symptoms at school at 3 months | Paralleling the VADPRS, the VADTRS will be completed by teachers. This version includes 3 of the same subscales in the parent version -- hyperactivity/impulsivity (n=9), inattention (n=9), and anxiety/depression (n=7) -- but it also includes an aggregated oppositional/conduct scale (n=10 items). Scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance subscale (n=8 items) that is used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional/conduct problems (30), anxiety/depression (21) ,and performance (24). Practices will continue to separately request their own forms during services (e.g., for medication monitoring). | 3 months after teacher baseline | |
Primary | Change from baseline in severity of ADHD, ODD/CD, and ANX/DEP symptoms at school at 6 months | Paralleling the VADPRS, the VADTRS will be completed by teachers. This version includes 3 of the same subscales in the parent version -- hyperactivity/impulsivity (n=9), inattention (n=9), and anxiety/depression (n=7) -- but it also includes an aggregated oppositional/conduct scale (n=10 items). Scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance subscale (n=8 items) that is used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional/conduct problems (30), anxiety/depression (21) ,and performance (24). Practices will continue to separately request their own forms during services (e.g., for medication monitoring). | 6 months after teacher baseline | |
Primary | Change from baseline in severity of ADHD, ODD/CD, and ANX/DEP symptoms at school at 12 months | Paralleling the VADPRS, the VADTRS will be completed by teachers. This version includes 3 of the same subscales in the parent version -- hyperactivity/impulsivity (n=9), inattention (n=9), and anxiety/depression (n=7) -- but it also includes an aggregated oppositional/conduct scale (n=10 items). Scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance subscale (n=8 items) that is used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional/conduct problems (30), anxiety/depression (21) ,and performance (24). Practices will continue to separately request their own forms during services (e.g., for medication monitoring). | 12 months after teacher baseline | |
Primary | Pediatric Health Quality | Caregivers will complete the Pediatric Quality of Life (PEDS-QL) to measure health-related quality of life which includes 4 subscales: health/physical status (n=8), emotional health (n=5), school health (n=5), and social health (n=5). All items are rated on a 5-point Likert scale (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). These subscales have very good reliability and treatment validity and are sensitive to the DOCC EBP. | At caregiver baseline | |
Primary | Change from baseline in Pediatric Health Quality at 3 months | Caregivers will complete the Pediatric Quality of Life (PEDS-QL) to measure health-related quality of life which includes 4 subscales: health/physical status (n=8), emotional health (n=5), school health (n=5), and social health (n=5). All items are rated on a 5-point Likert scale (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). These subscales have very good reliability and treatment validity and are sensitive to the DOCC EBP. | 3 months after caregiver baseline | |
Primary | Change from baseline in Pediatric Health Quality at 3 months | Caregivers will complete the Pediatric Quality of Life (PEDS-QL) to measure health-related quality of life which includes 4 subscales: health/physical status (n=8), emotional health (n=5), school health (n=5), and social health (n=5). All items are rated on a 5-point Likert scale (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). These subscales have very good reliability and treatment validity and are sensitive to the DOCC EBP. | 6 months after caregiver baseline | |
Primary | Change from baseline in Pediatric Health Quality at 12 months | Caregivers will complete the Pediatric Quality of Life (PEDS-QL) to measure health-related quality of life which includes 4 subscales: health/physical status (n=8), emotional health (n=5), school health (n=5), and social health (n=5). All items are rated on a 5-point Likert scale (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). These subscales have very good reliability and treatment validity and are sensitive to the DOCC EBP. | 12 months after caregiver baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03077321 -
Improving Access to a Primary Care Based Positive Parenting Program
|
N/A | |
Terminated |
NCT04075071 -
A Pilot Study of Teacher-Child Interaction Training - Universal in Head Start
|
N/A | |
Completed |
NCT04257331 -
Parent Training to Reduce Behavioral Problems in Children With Autism Spectrum Disorder in China
|
N/A | |
Completed |
NCT06311084 -
IMAGINATOR 2.0: Co-design and Early Evaluation of a Novel Blended Digital Intervention Targeting Self-harm in Young People
|
N/A | |
Completed |
NCT03283579 -
Fatty Acids and Attention Deficit and Hyperactivity Disorder Symptoms
|
||
Completed |
NCT04440228 -
TeamSTEPPS in School Mental Health
|
N/A | |
Completed |
NCT04786080 -
Supporting Parents & Kids Through Lockdown Experiences (SPARKLE).
|
N/A | |
Recruiting |
NCT04821856 -
Evaluation of the Effectiveness of Cannabidiol in Treating Severe Behavioural Problems in Children and Adolescents With Intellectual Disability
|
Phase 2 | |
Completed |
NCT05452954 -
Psychosocial ADHD Interventions - Brief Parent Training
|
N/A | |
Active, not recruiting |
NCT05096611 -
Attachment and Biobehavioral Catch-up and Depression Treatment
|
N/A | |
Completed |
NCT06195579 -
Nurtured Heart Parenting Intervention for Child Behavioural Problems
|
N/A | |
Recruiting |
NCT05444205 -
The Pittsburgh Study Early Childhood
|
N/A | |
Completed |
NCT05519943 -
Effectiveness of Group CBT in Children With Mixed Psychiatric Disorders
|
N/A | |
Completed |
NCT06274424 -
Hair Cortisol and Symptoms in Children With Psychopathology During CBT
|
N/A | |
Active, not recruiting |
NCT06040996 -
Evaluation of Improving Parenting Skills Adult ADHD (IPSA): A New Parent Training Program for Parents With ADHD
|
N/A | |
Completed |
NCT05776576 -
Physical Activity and Recreation School Program for Special Needs Individuals and Their Parents
|
||
Completed |
NCT05057728 -
Effectiveness of the Social-Emotional Prevention Program Enhanced Version
|
N/A | |
Recruiting |
NCT04942145 -
Effect of Virtual Reality on Dental Patients
|
N/A | |
Enrolling by invitation |
NCT04763720 -
Implementing Dyadic Developmental Psychotherapy (DDP) - Evaluation Research
|
||
Recruiting |
NCT04635969 -
Determining the Effectiveness of Sexual Health and Development Education for Children With Intellectual Disability
|
N/A |