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A Pragmatic Trial of Parent-focused Prevention in Pediatric Primary Care

Award Number: UH3AT009838
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/15/2018
PERIOD OF PERFORMANCE END DATE: 05/31/2025

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A Pragmatic Trial of Parent-focused Prevention in Pediatric Primary Care - Fifty percent of all adolescents will use some form of illicit drugs before the end of high school, 20-25% will meet criterial for depression, and many others will engage in health compromising behaviors like delinquency and violence—with consequences for their long-term health. Evidence-based interventions shown to prevent these behavioral health concerns could improve adolescent health trajectories if implemented widely in pediatric primary care. The American Academy of Pediatrics’ Bright Futures recommends that pediatricians offer developmentally tailored anticipatory guidance to all parents to support their children’s healthy development, but programs providing guidance are not offered universally. This UG3-UH3 application tests the feasibility and effectiveness of implementing Guiding Good Choices, a universal, evidence-based anticipatory guidance curriculum for parents of early adolescents, in three large, integrated healthcare systems serving socioeconomically diverse families. This intervention reduced adolescent alcohol, tobacco and marijuana use, depression, and general delinquency in two previous rigorous randomized controlled trials. It also strengthened parenting practices and parent-adolescent relationship quality, both broadly protective against behavioral health concerns. Guiding Good Choices has the capacity to achieve population-level impact on adolescent health if made widely available through pediatric primary care. Parents trust pediatricians’ advice regarding their children’s well-being, and current research with socioeconomically diverse groups suggests that they are eager to participate in family-focused programs offered in primary care clinics. Building on this body of research, the investigative team, in close cooperation with the NIH Healthcare Systems Research Collaboratory and healthcare systems partners, will conduct a cluster-randomized trial of Guiding Good Choices in 72 pediatric primary care practices. Half will be randomly assigned to offer the program universally to parents of adolescents ages 11 to 12, and half will serve as usual care controls. The study will use a workflow that is easy to adopt, implement, and maintain by primary care clinics to enroll families in the intervention at the adolescent well visit. We anticipate recruiting over 4,500 families into the trial. The team will use the RE-AIM framework to test implementation outcomes and effectiveness, including hypothesized reductions in several behavioral health problems (e.g., substance use initiation, mental health symptoms and diagnoses), and emergency department and inpatient service utilization. We will use data from the EHR and a supplemental behavioral health survey to monitor outcomes up to 3 years post intervention. We will also assess the feasibility and sustainability of implementing the intervention in each HCS, including health economic evaluation to understand costs in relation to value gained. Throughout the trial the investigative team will engage in ongoing dialog with HCS leaders, pediatricians, and clinic staff to ensure the intervention and implementation process fit the needs of each HCS. We anticipate that evidence of feasibility and effectiveness in three different HCS will foster broad dissemination to achieve public health impact.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = -$33,377 )
2026	2022	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	000	5	12/3/2025	NON-COMPETING CONTINUATION	-$33,377
														Subtotal = -$33,377

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	001	5	5/13/2024	SUPPLEMENT FOR EXPANSION	$0
2024	2022	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	000	5	5/7/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	000	5	10/20/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $1,679,268 )
2022	2022	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	000	5	6/8/2022	NON-COMPETING CONTINUATION	$1,424,326
2022	2022	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	001	5	9/14/2022	SUPPLEMENT FOR EXPANSION	$254,942
														Subtotal = $1,679,268

Issue Date FY: 2021 ( Subtotal = $1,437,320 )
2021	2021	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	000	4	6/15/2021	NON-COMPETING CONTINUATION	$1,437,320
														Subtotal = $1,437,320

Issue Date FY: 2020 ( Subtotal = $1,492,001 )
2020	2020	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	001	3	6/16/2020	NON-COMPETING CONTINUATION	$1,492,001
2020	2019	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	000	2	11/6/2019	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $1,492,001

Issue Date FY: 2019 ( Subtotal = $1,640,906 )
2019	2019	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	000	2	6/12/2019	EXTENSION WITH OR WITHOUT FUNDS	$1,540,949
2019	2019	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	001	2	8/30/2019	SUPPLEMENT FOR EXPANSION	$99,957
														Subtotal = $1,640,906

Grand Total All Awards = $6,216,118

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A Pragmatic Trial of Parent-focused Prevention in Pediatric Primary Care

Award Number: UH3AT009838

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/15/2018

PERIOD OF PERFORMANCE END DATE: 05/31/2025

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