Coaching Alternative Parenting Strategies (CAPS) Study

Parenting Clinical Trial

— CAPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02684903
• Other study ID #: 1R01DA036533-01A1
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: April 2022

Study information

• Verified date: October 2023
• Source: University of Oregon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: April 2022
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Child Abuse
• Parenting
• Self-control

Intervention

Behavioral:
• Parent Child Interaction Therapy
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.

Locations

Country	Name	City	State
United States	University of Oregon	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
University of Oregon

Country where clinical trial is conducted

United States, 

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* Note: There are 167 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BRIEF-A: Emotional Control Scale (Increased Parent Emotion Regulation)	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.	pre- and post-intervention (8 months)
Other	BRIEF (Behavioral Rating Inventory of Executive Function) Children's Outcomes	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.	pre- and post-intervention
Other	Parent Physiological Regulation	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).	pre- and post-intervention
Other	Child Emotion Regulation	Emotional go/no-go task performance: False alarms to anger. Higher scores reflect greater rate of false alarms to anger (worse outcome).	Post intervention (6 mo)
Other	Child Physiological Regulation	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).	pre- and post-intervention (8 months)
Other	Decreased Child Symptoms	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	pre- and post-intervention (8 months)
Other	Eyberg Child Behavior Inventory (ECBI) Child Behavior Problem Scores (Decreased Disruptive Behavior Problems)	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.	pre- and post-intervention (8 months)
Other	BRIEF-A: Parent Self-ratings	Parents self-report on the BRIEF- A with lower scores reflecting fewer regulatory control problems. Standardized T-scores (M=50, SD = 10) are obtained.	pre- and post-intervention (8 months)
Primary	DPICS-IV Observed Parenting Skills (During Child-Led Play)	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.	Pre- and Post-intervention (8 months)
Primary	DPICS-IV Observational Coding During Clean Up Situation Task	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.	Pre- and Post-intervention (8 months)
Primary	Stop Signal Task: Increased Parent Inhibitory Control	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.	pre- and post-intervention (8 months)
Secondary	Reduced Child Maltreatment (CM) Recidivism	Fewer new episodes of CM per Maltreatment Classification Coding of Child Welfare case records	up to 1 year posttreatment