跳至主要内容
临床试验/NCT02684903
NCT02684903已完成不适用

Coaching Alternative Parenting Strategies (CAPS) Study: Targeting Neurobiological and Behavioral Mechanisms of Self-regulation in High-risk Families

University of Oregon2 个研究点 分布在 1 个国家目标入组 408 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
408
试验地点
2
主要终点
DPICS-IV Observed Parenting Skills (During Child-Led Play)

研究概览

简要总结

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 children's 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.

详细描述

Child maltreatment (CM) constitutes a serious public health problem in the United States and is known to compromise children's 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 PCIT's 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 children's behavioral adjustment. It is hypothesized that intervention families will show significantly greater behavior improvements (i.e., decreased negative parenting, increased positive parenting, and decreased child internalizing/externalizing 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 (i.e., 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 children's self-regulation. CM exerts detrimental effects on children's 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 children's 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
3 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Resident of Lane County
  • Parent is 18 or older
  • Biological or custodial mother of a child between age 3 and 7 years at baseline
  • Resides in the same home setting with the child
  • Must be fluent in English
  • Mom and child must be physically able to complete the assessment
  • Family has an open case with Lane County Dept. Health Services.

排除标准

  • Child sexual abuse in the family

结局指标

主要结局

DPICS-IV Observed Parenting Skills (During Child-Led Play)

时间窗: Pre- and Post-intervention (8 months)

Dyadic Parent-Child Interaction Coding System (DPICS) coded positive "PRIDE" parenting skills and negative "Don't skills" parenting behaviors during the DPICS Child-Led Play task. Scores reflect behavioral counts during the 5-minute task, with higher scores reflecting more behaviors. Higher positive parenting scores reflect better outcomes, whereas higher negative parenting scores reflect worse outcomes.

Stop Signal Task: Increased Parent Inhibitory Control

时间窗: pre- and post-intervention (8 months)

The Stop Signal Response Time (SSRT) was used to assess the efficiency of parent inhibitory control process or time in milliseconds needed to engage an inhibitory response. Lower SSRT scores reflect faster reaction times and better inhibitory control.

DPICS-IV Observational Coding During Clean Up Situation Task

时间窗: Pre- and Post-intervention (8 months)

DPICS-Coded Positive "PRIDE" Parenting skills, Effective Parent Commands, and Child Compliance behaviors during the DPICS Clean Up Situation task. Positive parenting scores reflect the percentage of total coded behaviors during the task that are positive "PRIDE" skills. Effective (direct) parent commands reflect the percentage of all commands that were direct, compliable commands. Child compliance scores reflected the percentage of effective, direct commands that child complied with in the immediately following behavioral turn. High scores on all three scales reflect better outcomes.

次要结局

  • Reduced Child Maltreatment (CM) Recidivism(up to 1 year posttreatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Skowron

Professor, Department of Psychology

University of Oregon

研究点 (2)

Loading locations...

相似试验

Unknown
不适用
Child and Parent-directed Individualized Psychotherapy (CPIP)Child NeglectInternalizing Disorder
NCT05128669University of Leipzig200
进行中(未招募)
不适用
Parent Acceptance and Commitment Therapy (PACT) for Parents of Children With Pediatric Feeding DisorderPediatric Feeding Disorder, ChronicPediatric Feeding Dysfunction, Acute
NCT06001398Children's Mercy Hospital Kansas City73
已完成
不适用
A Trial of Parent-coached Exposure Therapy for Children With Anxiety Disorders and OCDObsessive-Compulsive DisorderAnxiety Disorders
NCT05777161Mayo Clinic162
尚未招募
不适用
Telehealth Parent Coaching to Improve Activity Participation for Young Children With ASD and SPDSensory Processing DisorderAutism Spectrum Disorder
NCT06079632National Taiwan University Hospital68
招募中
不适用
The Oklahoma Parent-Child Assistance ProgramSubstance Use DisordersPregnancy RelatedAlcohol Use Disorder (AUD)Alcohol Use Complicating Pregnancy, First TrimesterAlcohol Use Complicating Pregnancy, Second TrimesterAlcohol Use Complicating Pregnancy, Third TrimesterAlcohol Use Complicating Pregnancy, Unspecified TrimesterAlcohol Use Complicating Pregnancy, Childbirth, and the PuerperiumFetal Alcohol Spectrum DisordersDrug Use DisordersDrug Use Complicating Pregnancy, First TrimesterDrug Use Complicating Pregnancy, Second TrimesterDrug Use Complicating Pregnancy, Third TrimesterDrug Use Complicating Pregnancy, Unspecified TrimesterDrug Use Complicating Pregnancy, Childbirth, and the PuerperiumMaternal Drugs Affecting FetusFetal Alcohol Syndrome
NCT05534568University of Oklahoma200