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Completed

NCT Number: NCT02684903

Coaching Alternative Parenting Strategies (CAPS) Study

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.

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Key information

Conditions

Child Abuse Behavior Parenting Self-Control Social Behavior

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oregon

Eugene, Oregon, 97403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Child sexual abuse in the family

Treatment and study plan

Parent Child Interaction Therapy

Behavioral

PCIT is a 16-20 session live-coaching parenting intervention. PCIT for Child Welfare families is delivered in two sequential treatment phases following a motivational enhancement training: Phase 1, Child-Directed Interaction (CDI) to enhance positive parenting and interrupt harsh aversive parenting, and Phase 2, Parent-Directed Interaction (PDI) to coach effective parent commands and a consistent time-out protocol when child disobeys.

Other names: PCIT

Primary outcomes

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

    Time frame: 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.

  2. DPICS-IV Observational Coding During Clean Up Situation Task

    Time frame: 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.

  3. Stop Signal Task: Increased Parent Inhibitory Control

    Time frame: 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.

Secondary outcomes

  1. Reduced Child Maltreatment (CM) Recidivism

    Time frame: up to 1 year posttreatment

    Fewer new episodes of CM per Maltreatment Classification Coding of Child Welfare case records

Other outcomes

  1. BRIEF-A: Emotional Control Scale (Increased Parent Emotion Regulation)

    Time frame: pre- and post-intervention (8 months)

    Parents self-report on the BRIEF- A Emotional Control problem scale, with lower scores reflecting fewer emotion control problems (i.e., better emotion regulation). Standardized T-scores (M=50, SD = 10) are obtained.

  2. BRIEF (Behavioral Rating Inventory of Executive Function) Children's Outcomes

    Time frame: pre- and post-intervention

    Children's BRIEF scores per parent-report on Inhibit, Shift, and Emotional Control problems scales, with lower scores reflecting fewer regulatory problems. Standardized T-scores (M=50, SD = 10) are obtained.

  3. Parent Physiological Regulation

    Time frame: pre- and post-intervention

    physiological regulation (Respiratory Sinus Arrhythmia or RSA scores, are a peripheral physiological marker of emotion regulation reflecting parents' parasympathetic nervous system linked cardiac activity. RSA scores were obtained from parents at rest and in response to emotionally salient interactions with their child. Higher RSA scores reflect greater parasympathetic cardiac regulation (better outcome).

  4. Child Emotion Regulation

    Time frame: Post intervention (6 mo)

    Emotional go/no-go task performance: False alarms to anger. Higher scores reflect greater rate of false alarms to anger (worse outcome).

  5. Child Physiological Regulation

    Time frame: pre- and post-intervention (8 months)

    physiological regulation (Respiratory Sinus Arrhythmia or RSA scores, are a peripheral physiological marker of emotion regulation reflecting children's parasympathetic nervous system linked cardiac activity. RSA scores were obtained from children at rest and in response to emotionally salient interactions with their parent. Higher RSA scores reflect greater parasympathetic cardiac regulation (better outcome).

  6. Decreased Child Symptoms

    Time frame: pre- and post-intervention (8 months)

    Trauma Symptom Checklist scores (TSCL-YC); T-scores are reported, in which 50 indicates the population mean with a standard deviation of 10; higher scores indicate greater trauma symptoms. Clinically significant elevations on the TSCL-YC are reflected by scores at or above T=70 cutoff

  7. Eyberg Child Behavior Inventory (ECBI) Child Behavior Problem Scores (Decreased Disruptive Behavior Problems)

    Time frame: pre- and post-intervention (8 months)

    The ECBI is comprised of parent-reported intensity of problem child behaviors (ECBI-Intensity score) and number of problem child behaviors (EBCI-Problem score). Standardized T-scores (M=50, SD=10) are reported, with lower scores reflecting more successful outcome.

  8. BRIEF-A: Parent Self-ratings

    Time frame: pre- and post-intervention (8 months)

    Parents self-report on the BRIEF- A with lower scores reflecting fewer regulatory control problems. Standardized T-scores (M=50, SD = 10) are obtained.

Sponsors and collaborators

Lead sponsor

University of Oregon

Other

Registry information

Official study title

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

Acronym: CAPS

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Feb 18, 2016
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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