Ignite Creation Date:
2024-05-06 @ 8:10 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02684903
Status:
COMPLETED
Last Update Posted:
2023-11-02
First Post:
2016-02-02
Brief Title:
Coaching Alternative Parenting Strategies CAPS Study
Sponsor:
University of Oregon
Organization:
University of Oregon
Study Overview
Official Title:
Coaching Alternative Parenting Strategies CAPS Study Targeting Neurobiological and Behavioral Mechanisms of Self-regulation in High-risk Families
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPS
Brief Summary:
This is a randomized controlled trial RCT of Parent-Child Interaction Therapy PCIT designed to test the effects of PCIT on self-regulation and behavior in child maltreating CM parents and their elementary-school children Two hundred-fifty 250 maltreating mothers and their children age 5-8 years will be drawn from Child Protective Services and randomized to the PCIT intervention or a control condition services as usual Key contextual risk factors will be assessed including cumulative risk parent mental health and parent substance use A multirater multimethod approach to assessment will include measures of self-regulation parenting skills and childrens behavior outcomes Families will be followed to 1 year for CM recidivism Findings from this proposed study are expected to have significant implications for optimizing CM parenting interventions by a determining the sensitivity of CM parent and child neurobehavioral self-regulation systems to intervention and b identifying individual differences in self-regulation that mediate and moderate response to intervention and long-term maintenance of gains
Detailed Description:
Child maltreatment CM constitutes a serious public health problem in the United States and is known to compromise childrens developing self-regulation skills and amplify risk for substance use and other regulatory disorders Parent-Child Interaction Therapy PCIT an intensive 20-session parenting intervention has been shown to improve the quality of CM parenting improve positive parenting and child behavior and produce declines in CM recidivism Chaffin et al 2004 though the mechanisms underlying its effects are little understood This project addresses gaps in the CM intervention literature in that it a uses an experimental intervention design to test a theoretical model of change underlying PCITs effects b includes a battery of neurobehavioral measures of self-regulation and c uses observational measures of parenting in an RCT of an evidence-based intervention for strengthening parent self-regulation reducing CM and supporting improvements in child regulation and behavior Study aims are to
Aim 1 Test the main effects of PCIT on CM-specific outcomes including reductions in harsh aversive parenting and CM recidivism and promotion of childrens behavioral adjustment It is hypothesized that intervention families will show significantly greater behavior improvements ie decreased negative parenting increased positive parenting and decreased child internalizingexternalizing problems at posttest and lower CM recidivism at 6-month follow-up compared to families receiving services as usual SAU
Specific Aim 2 Determine the impact of PCIT on indices of CM parents self-regulation First the investigators will test the hypothesis that PCIT exerts direct effects on improving CM parents capacities for self-regulation in the context of parenting Second the investigators will investigate how measures of self-regulation in parents mediate PCIT intervention effects on reductions in CM and improvements in parenting Third the investigators will explore whether parents preintervention self-regulation levels moderate intervention effects on outcomes The moderating roles of CM subtype ie physical abuse vs neglect severity and other key sociocontextual factors on the outcomes of interest also will be considered
Specific Aim 3 Investigate the impact of PCIT on neurobehavioral indices of CM childrens self-regulation CM exerts detrimental effects on childrens developing capacities to regulate attention emotion physiology and behavior Deficits in these domains confer heightened risk for psychopathology early-onset conduct problems and later substance abuse The investigators hypothesize that PCIT though directed primarily toward parenting will effect improvements in neurobiological indicators of CM childrens self-regulation at post-treatment relative to the control group Next the investigators will test the extent to which child outcomes are mediated through intervention effects on parenting It is hypothesized that child regulatory deficits and behavior problems will be attenuated by PCIT-based reductions in aversive parenting that result from the intervention
Aim 1 Test the main effects of PCIT on CM-specific outcomes including reductions in harsh aversive parenting and CM recidivism and promotion of childrens behavioral adjustment It is hypothesized that intervention families will show significantly greater behavior improvements ie decreased negative parenting increased positive parenting and decreased child internalizingexternalizing problems at posttest and lower CM recidivism at 6-month follow-up compared to families receiving services as usual SAU
Specific Aim 2 Determine the impact of PCIT on indices of CM parents self-regulation First the investigators will test the hypothesis that PCIT exerts direct effects on improving CM parents capacities for self-regulation in the context of parenting Second the investigators will investigate how measures of self-regulation in parents mediate PCIT intervention effects on reductions in CM and improvements in parenting Third the investigators will explore whether parents preintervention self-regulation levels moderate intervention effects on outcomes The moderating roles of CM subtype ie physical abuse vs neglect severity and other key sociocontextual factors on the outcomes of interest also will be considered
Specific Aim 3 Investigate the impact of PCIT on neurobehavioral indices of CM childrens self-regulation CM exerts detrimental effects on childrens developing capacities to regulate attention emotion physiology and behavior Deficits in these domains confer heightened risk for psychopathology early-onset conduct problems and later substance abuse The investigators hypothesize that PCIT though directed primarily toward parenting will effect improvements in neurobiological indicators of CM childrens self-regulation at post-treatment relative to the control group Next the investigators will test the extent to which child outcomes are mediated through intervention effects on parenting It is hypothesized that child regulatory deficits and behavior problems will be attenuated by PCIT-based reductions in aversive parenting that result from the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None