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A Clinical Trial for Treatment-Resistant Subtypes of Self Injury

Award Number: R01HD076653
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/27/2013
PERIOD OF PERFORMANCE END DATE: 05/31/2025

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A Clinical Trial for Treatment-Resistant Subtypes of Self Injury - Project Summary/Abstract At least one quarter of the 18 million persons in the US with intellectual and developmental disabilities engage in self-injurious behavior (SIB), which can result in injuries, disfigurement, and loss of function (e.g., blindness). In most cases, SIB is maintained by social reinforcement (e.g., attention). SIB that persists in the absence of social reinforcement has been referred to as automatically reinforced SIB (ASIB), based on the supposition that the behavior itself produces some type of biological reinforcement. The current standard of care approach to treatment for ASIB includes two phases: a Pre-Treatment Assessment (a Competing Stimulus Assessment to identify stimuli associated with reductions in ASIB), followed by treatment where competing stimuli are delivered on a noncontingent reinforcement (NCR) schedule. Our NICHD- supported research to date has identified subtypes of ASIB that vary greatly in terms of their responsiveness to these treatments. Subtypes are based on results of standardized assessment conditions: Subtype 1 varies inversely with the level of stimulation across conditions; Subtype 2 is invariant; and Subtype 3 is characterized by self-restraint, a self-limiting behavior that occurs to avoid ASIB, but also impairs adaptive functioning. Treatments using NCR with competing stimuli alone are effective in over 82% of cases with Subtype 1, but in only 7% of cases with Subtype 2 or 3, necessitating restraint or protective equipment to sufficiently reduce ASIB. The identification of subtypes has revealed the urgent need for more effective interventions for the treatment-resistant subtypes. Fortunately, our research (R01 HD076653) has also led to several recent discoveries that provide the conceptual and empirical basis for a new Intensified Approach to treatment targeting the most treatment-resistant subtypes (Subtype 2 and 3 ASIB). The proposed treatment approach is based on the same principles as the current Standard of Care Approach (Matching Law and reinforcer competition), but employs novel methods to more effectively compete with reinforcement maintaining Subtype 2 and 3 ASIB, and to address self-restraint for Subtype 3. The proposed Intensified Approach to treatment includes three phases: 1) Pre-Treatment Assessments will identify competing stimuli, tasks, and self-control devices that reduce ASIB; 2) Intensive Training to strengthen skills needed to fully access available reinforcement, and replace debilitating self-restraint; and 3) Combination Treatment using NCR to deliver, and differential reinforcement for engagement with: multiple competing stimuli, competing tasks, and alternative self-control devices (for Subtype 3). Combination Treatment is designed to greatly increase the amount and vary the sources of alternative reinforcement. Aim 1 is to identify and establish competing stimuli, competing tasks, and self-control devices (Subtype 3 ASIB). Aim 2 is to employ a randomized crossover design to demonstrate the effectiveness of Combination Treatment (developed using the Intensified Approach), relative to NCR with competing stimuli alone (developed using the current Standard of Care Approach) for reducing ASIB and self-restraint.


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: 2025 ( Subtotal = $0 )
2025	2024	HUGO W. MOSER RESEARCH INSTITUTE AT KENNEDY KRIEGER, INC.	707 N BROADWAY	BALTIMORE	MD	21205	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	000	10	12/13/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $333,354 )
2024	2024	HUGO W. MOSER RESEARCH INSTITUTE AT KENNEDY KRIEGER, INC.	707 N BROADWAY	BALTIMORE	MD	21205	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	001	10	5/6/2024	NON-COMPETING CONTINUATION	$30,305
2024	2024	HUGO W. MOSER RESEARCH INSTITUTE AT KENNEDY KRIEGER, INC.	707 N BROADWAY	BALTIMORE	MD	21205	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	000	10	2/29/2024	NON-COMPETING CONTINUATION	$303,049
														Subtotal = $333,354

Issue Date FY: 2023 ( Subtotal = $336,716 )
2023	2023	HUGO W. MOSER RESEARCH INSTITUTE AT KENNEDY KRIEGER, INC.	707 N BROADWAY	BALTIMORE	MD	21205	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	001	9	3/9/2023	NON-COMPETING CONTINUATION	$336,716
2023	2021	HUGO W. MOSER RESEARCH INSTITUTE AT KENNEDY KRIEGER, INC.	707 N BROADWAY	BALTIMORE	MD	21205	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	000	8	1/25/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $336,716

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	HUGO W. MOSER RESEARCH INSTITUTE AT KENNEDY KRIEGER, INC.	707 N BROADWAY	BALTIMORE	MD	21205	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	000	8	8/17/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $336,712 )
2021	2021	HUGO W. MOSER RESEARCH INSTITUTE AT KENNEDY KRIEGER, INC.	707 N BROADWAY	BALTIMORE	MD	21205	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	000	8	5/19/2021	NON-COMPETING CONTINUATION	$336,712
														Subtotal = $336,712

Issue Date FY: 2020 ( Subtotal = $343,579 )
2020	2020	HUGO W. MOSER RESEARCH INSTITUTE AT KENNEDY KRIEGER, INC.	707 N BROADWAY	BALTIMORE	MD	21205	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	000	7	6/30/2020	NON-COMPETING CONTINUATION	$343,579
														Subtotal = $343,579

Issue Date FY: 2019 ( Subtotal = $343,574 )
2019	2019	HUGO W. MOSER RESEARCH INSTITUTE AT KENNEDY KRIEGER, INC.	707 N BROADWAY	BALTIMORE	MD	21205	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	002	6	9/20/2019	COMPETING CONTINUATION	$63,960
2019	2019	HUGO W. MOSER RESEARCH INSTITUTE AT KENNEDY KRIEGER, INC.	707 N BROADWAY	BALTIMORE	MD	21205	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	000	6	5/29/2019	COMPETING CONTINUATION	$343,574
2019	2017	HUGO W. MOSER RESEARCH INSTITUTE AT KENNEDY KRIEGER, INC.	707 N BROADWAY	BALTIMORE	MD	21205	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	001	5	9/20/2019	NON-COMPETING CONTINUATION	-$63,960
														Subtotal = $343,574

Issue Date FY: 2017 ( Subtotal = $301,816 )
2017	2017	HUGO W. MOSER RESEARCH INSTITUTE AT KENNEDY KRIEGER, INC.	707 N BROADWAY	BALTIMORE	MD	21205	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	000	5	7/5/2017	NON-COMPETING CONTINUATION	$301,816
														Subtotal = $301,816

Issue Date FY: 2016 ( Subtotal = $298,796 )
2016	2016	HUGO W MOSER RESEARCH INSTITUTE AT KENNEDY KRIEGER INC	707 NORTH BROADWAY	BALTIMORE	MD	21205	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	000	4	6/1/2016	EXTENSION WITH OR WITHOUT FUNDS	$298,796
														Subtotal = $298,796

Issue Date FY: 2015 ( Subtotal = $294,268 )
2015	2015	HUGO W MOSER RESEARCH INSTITUTE AT KENNEDY KRIEGER INC	707 NORTH BROADWAY	BALTIMORE	MD	21205	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	000	3	5/19/2015	NON-COMPETING CONTINUATION	$294,268
														Subtotal = $294,268

Issue Date FY: 2014 ( Subtotal = $293,363 )
2014	2014	HUGO W MOSER RESEARCH INSTITUTE AT KENNEDY KRIEGER INC	707 NORTH BROADWAY	BALTIMORE	MD	21205	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	000	2	6/5/2014	NON-COMPETING CONTINUATION	$293,363
														Subtotal = $293,363

Issue Date FY: 2013 ( Subtotal = $298,591 )
2013	2013	HUGO W MOSER RESEARCH INSTITUTE AT KENNEDY KRIEGER INC	707 NORTH BROADWAY	BALTIMORE	MD	21205	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	000	1	9/27/2013	NEW	$298,591
														Subtotal = $298,591

Grand Total All Awards = $3,180,769

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A Clinical Trial for Treatment-Resistant Subtypes of Self Injury

Award Number: R01HD076653

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/27/2013

PERIOD OF PERFORMANCE END DATE: 05/31/2025

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