Trial Outcomes & Findings for Coaching Alternative Parenting Strategies (CAPS) Study (NCT NCT02684903)

Last Updated: 2023-11-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

408 participants

Primary outcome timeframe

Pre- and Post-intervention (8 months)

Results posted on

2023-11-02

Participant Flow

Number Started represents the number of parent participants and the number of child participants. There were 204 parent participants and 204 child participants enrolled for a total of 408 participants (in 204 parent-child dyads).

Participant milestones

Participant milestones
Measure	Services As Usual (SAU) Participants receive all the usual services provided by DHS- Children's Services.	Parent Child Interaction Therapy (PCIT) Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.
Overall Study STARTED	168	240
Overall Study COMPLETED	133	193
Overall Study NOT COMPLETED	35	47

Reasons for withdrawal

Reasons for withdrawal
Measure	Services As Usual (SAU) Participants receive all the usual services provided by DHS- Children's Services.	Parent Child Interaction Therapy (PCIT) Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.
Overall Study COVID-19 shutdown of lab	4	6
Overall Study Lost to Follow-up	31	41

Baseline Characteristics

Only the 204 parents' age data were included in this analysis.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Pre- and Post-intervention (8 months)

Population: These participating child welfare-involved families were block-randomized to condition by child sex and age, with allocation ratio of PCIT to control group conditions at 1.5:1 to ensure that a sufficient number of families accessed the intervention.

Outcome measures

Outcome measures
Measure	Services As Usual (SAU) n=84 Participants Participants receive all the usual services provided by Department of Human Services (DHS) Children's Services.	Parent Child Interaction Therapy (PCIT) n=120 Participants All participants randomized to PCIT condition. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.	Parent Child Interaction Therapy (PCIT) (Engagers Only) n=79 Participants All participants randomized to PCIT condition who engaged in 1+ sessions. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.
DPICS-IV Observed Parenting Skills (During Child-Led Play) Positive Parenting "PRIDE" skills (pre-treatment)	2.32 number of behaviors Standard Deviation 2.32	2.63 number of behaviors Standard Deviation 2.92	2.86 number of behaviors Standard Deviation 3.10
DPICS-IV Observed Parenting Skills (During Child-Led Play) Positive Parenting "PRIDE" skills (post-treatment)	2.11 number of behaviors Standard Deviation 2.20	8.01 number of behaviors Standard Deviation 9.61	10.19 number of behaviors Standard Deviation 10.47
DPICS-IV Observed Parenting Skills (During Child-Led Play) Negative Parenting "Don't" skills (pre-treatment)	23.62 number of behaviors Standard Deviation 11.66	23.61 number of behaviors Standard Deviation 11.78	24.16 number of behaviors Standard Deviation 11.92
DPICS-IV Observed Parenting Skills (During Child-Led Play) Negative Parenting "Don't" skills (post-treatment)	21.80 number of behaviors Standard Deviation 11.31	14.82 number of behaviors Standard Deviation 9.99	13.30 number of behaviors Standard Deviation 9.42

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Services As Usual (SAU) n=84 Participants Participants receive all the usual services provided by Department of Human Services (DHS) Children's Services.	Parent Child Interaction Therapy (PCIT) n=120 Participants All participants randomized to PCIT condition. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.	Parent Child Interaction Therapy (PCIT) (Engagers Only) n=79 Participants All participants randomized to PCIT condition who engaged in 1+ sessions. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.
DPICS-IV Observational Coding During Clean Up Situation Task Effective commands (pre-treatment)	0.56 percentage of all parenting behaviors Standard Deviation 0.26	0.54 percentage of all parenting behaviors Standard Deviation 0.25	0.53 percentage of all parenting behaviors Standard Deviation 0.24
DPICS-IV Observational Coding During Clean Up Situation Task Effective commands (post-treatment)	0.63 percentage of all parenting behaviors Standard Deviation 0.27	0.60 percentage of all parenting behaviors Standard Deviation 0.29	0.59 percentage of all parenting behaviors Standard Deviation 0.29
DPICS-IV Observational Coding During Clean Up Situation Task Child compliance with parent commands (pre-treatment)	0.69 percentage of all parenting behaviors Standard Deviation 0.28	0.73 percentage of all parenting behaviors Standard Deviation 0.28	0.71 percentage of all parenting behaviors Standard Deviation 0.31
DPICS-IV Observational Coding During Clean Up Situation Task Child compliance with parent commands (post-treatment)	0.78 percentage of all parenting behaviors Standard Deviation 0.22	0.76 percentage of all parenting behaviors Standard Deviation 0.29	0.75 percentage of all parenting behaviors Standard Deviation 0.31
DPICS-IV Observational Coding During Clean Up Situation Task Positive Parenting "PRIDE" skills (pre-treatment)	0.65 percentage of all parenting behaviors Standard Deviation 0.27	0.62 percentage of all parenting behaviors Standard Deviation 0.29	0.63 percentage of all parenting behaviors Standard Deviation 0.28
DPICS-IV Observational Coding During Clean Up Situation Task Positive Parenting "PRIDE" skills (post-treatment)	0.69 percentage of all parenting behaviors Standard Deviation 0.28	0.70 percentage of all parenting behaviors Standard Deviation 0.31	0.71 percentage of all parenting behaviors Standard Deviation 0.31

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Services As Usual (SAU) n=84 Participants Participants receive all the usual services provided by Department of Human Services (DHS) Children's Services.	Parent Child Interaction Therapy (PCIT) n=120 Participants All participants randomized to PCIT condition. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.	Parent Child Interaction Therapy (PCIT) (Engagers Only) n=79 Participants All participants randomized to PCIT condition who engaged in 1+ sessions. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.
Stop Signal Task: Increased Parent Inhibitory Control Stop signal response time (SSRT) (pre-treatment)	252.84 milliseconds Standard Deviation 68.07	248.25 milliseconds Standard Deviation 54.40	251.44 milliseconds Standard Deviation 58.18
Stop Signal Task: Increased Parent Inhibitory Control Stop signal response time (SSRT) (post-treatment)	255.16 milliseconds Standard Deviation 57.94	237.45 milliseconds Standard Deviation 47.89	236.28 milliseconds Standard Deviation 45.33

SECONDARY outcome

Timeframe: up to 1 year posttreatment

Population: These data are not available from DHS child welfare on the study participants and thus not available to our study team to report here. We have been told that this is due to the fact that the DHS agency internal record-keeping systems do not have data on the study families.

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Services As Usual (SAU) n=84 Participants Participants receive all the usual services provided by Department of Human Services (DHS) Children's Services.	Parent Child Interaction Therapy (PCIT) n=120 Participants All participants randomized to PCIT condition. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.	Parent Child Interaction Therapy (PCIT) (Engagers Only) n=79 Participants All participants randomized to PCIT condition who engaged in 1+ sessions. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.
BRIEF-A: Emotional Control Scale (Increased Parent Emotion Regulation) Emotional Control problems (pre-treatment)	52.57 T-scores Standard Deviation 9.18	53.95 T-scores Standard Deviation 10.87	55.06 T-scores Standard Deviation 11.38
BRIEF-A: Emotional Control Scale (Increased Parent Emotion Regulation) Emotional Control problems (post-treatment)	54.95 T-scores Standard Deviation 11.21	52.72 T-scores Standard Deviation 11.03	53.33 T-scores Standard Deviation 10.97

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Services As Usual (SAU) n=84 Participants Participants receive all the usual services provided by Department of Human Services (DHS) Children's Services.	Parent Child Interaction Therapy (PCIT) n=120 Participants All participants randomized to PCIT condition. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.	Parent Child Interaction Therapy (PCIT) (Engagers Only) n=79 Participants All participants randomized to PCIT condition who engaged in 1+ sessions. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.
BRIEF (Behavioral Rating Inventory of Executive Function) Children's Outcomes Emotional control problems (posttreatment)	54.42 T-scores Standard Deviation 10.30	52.87 T-scores Standard Deviation 11.14	53.03 T-scores Standard Deviation 11.49
BRIEF (Behavioral Rating Inventory of Executive Function) Children's Outcomes Inhibition problems (pre-treatment)	59.11 T-scores Standard Deviation 12.00	58.36 T-scores Standard Deviation 12.34	59.84 T-scores Standard Deviation 11.76
BRIEF (Behavioral Rating Inventory of Executive Function) Children's Outcomes Inhibition problems (post-treatment)	60.12 T-scores Standard Deviation 11.72	57.98 T-scores Standard Deviation 10.88	58.55 T-scores Standard Deviation 10.92
BRIEF (Behavioral Rating Inventory of Executive Function) Children's Outcomes Shift problems (pretreatment)	54.86 T-scores Standard Deviation 13.08	57.10 T-scores Standard Deviation 11.55	58.63 T-scores Standard Deviation 11.07
BRIEF (Behavioral Rating Inventory of Executive Function) Children's Outcomes Shift problems (posttreatment)	55.46 T-scores Standard Deviation 12.95	55.27 T-scores Standard Deviation 10.89	55.90 T-scores Standard Deviation 10.94
BRIEF (Behavioral Rating Inventory of Executive Function) Children's Outcomes Emotional control problems (pretreatment)	54.30 T-scores Standard Deviation 12.58	54.79 T-scores Standard Deviation 11.76	56.09 T-scores Standard Deviation 12.07

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Services As Usual (SAU) n=84 Participants Participants receive all the usual services provided by Department of Human Services (DHS) Children's Services.	Parent Child Interaction Therapy (PCIT) n=120 Participants All participants randomized to PCIT condition. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.	Parent Child Interaction Therapy (PCIT) (Engagers Only) n=79 Participants All participants randomized to PCIT condition who engaged in 1+ sessions. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.
Parent Physiological Regulation Parent Resting RSA (at pretreatment)	6.30 ms^2 Standard Deviation 1.38	5.97 ms^2 Standard Deviation 1.45	5.88 ms^2 Standard Deviation 1.53
Parent Physiological Regulation Parent Resting RSA (at posttreatment)	5.77 ms^2 Standard Deviation 1.59	5.57 ms^2 Standard Deviation 1.71	5.35 ms^2 Standard Deviation 1.71
Parent Physiological Regulation Parent RSA during DPICS Child-Led Play Task (pretreatment)	5.99 ms^2 Standard Deviation 1.38	5.76 ms^2 Standard Deviation 1.37	5.67 ms^2 Standard Deviation 1.44
Parent Physiological Regulation Parent RSA during DPICS Child-Led Play Task (posttreatment)	5.57 ms^2 Standard Deviation 1.48	5.58 ms^2 Standard Deviation 1.54	5.52 ms^2 Standard Deviation 1.57
Parent Physiological Regulation Parent RSA during DPICS Clean Up Task (pretreatment)	6.05 ms^2 Standard Deviation 1.22	5.79 ms^2 Standard Deviation 1.29	5.71 ms^2 Standard Deviation 1.32
Parent Physiological Regulation Parent RSA during DPICS Clean Up Task (posttreatment)	5.81 ms^2 Standard Deviation 1.44	5.51 ms^2 Standard Deviation 1.39	5.41 ms^2 Standard Deviation 1.43
Parent Physiological Regulation Parent RSA during Social Engagement task (pretreatment)	6.51 ms^2 Standard Deviation 1.24	6.19 ms^2 Standard Deviation 1.36	6.02 ms^2 Standard Deviation 1.43
Parent Physiological Regulation Parent RSA during Social Engagement task (posttreatment)	6.27 ms^2 Standard Deviation 1.48	5.98 ms^2 Standard Deviation 1.46	5.85 ms^2 Standard Deviation 1.47

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Services As Usual (SAU) n=84 Participants Participants receive all the usual services provided by Department of Human Services (DHS) Children's Services.	Parent Child Interaction Therapy (PCIT) n=120 Participants All participants randomized to PCIT condition. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.	Parent Child Interaction Therapy (PCIT) (Engagers Only) n=79 Participants All participants randomized to PCIT condition who engaged in 1+ sessions. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.
Child Emotion Regulation Child False Alarms to Anger (pretreatment)	0.38 percentage of responses Standard Deviation 0.27	0.40 percentage of responses Standard Deviation 0.31	0.41 percentage of responses Standard Deviation 0.31
Child Emotion Regulation Child False Alarms to Anger (posttreatment)	0.38 percentage of responses Standard Deviation 0.28	0.34 percentage of responses Standard Deviation 0.24	0.35 percentage of responses Standard Deviation 0.24

OTHER_PRE_SPECIFIED outcome

Timeframe: pre- and post-intervention (8 months)

Population: CHILD RSA data reported here

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).

Outcome measures

Outcome measures
Measure	Services As Usual (SAU) n=84 Participants Participants receive all the usual services provided by Department of Human Services (DHS) Children's Services.	Parent Child Interaction Therapy (PCIT) n=120 Participants All participants randomized to PCIT condition. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.	Parent Child Interaction Therapy (PCIT) (Engagers Only) n=79 Participants All participants randomized to PCIT condition who engaged in 1+ sessions. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.
Child Physiological Regulation Child resting RSA (pretreatment)	6.68 ms^2 Standard Deviation 1.20	6.41 ms^2 Standard Deviation 1.40	6.48 ms^2 Standard Deviation 1.34
Child Physiological Regulation Child resting RSA (postreatment)	6.36 ms^2 Standard Deviation 1.33	6.47 ms^2 Standard Deviation 1.31	6.35 ms^2 Standard Deviation 1.25
Child Physiological Regulation Child RSA during child-led play task (pretreatment)	5.40 ms^2 Standard Deviation 1.10	5.38 ms^2 Standard Deviation 1.10	5.42 ms^2 Standard Deviation 1.12
Child Physiological Regulation Child RSA during child-led play task (posttreatment)	5.28 ms^2 Standard Deviation 1.04	5.33 ms^2 Standard Deviation 1.22	5.29 ms^2 Standard Deviation 1.18
Child Physiological Regulation Child RSA during clean-up task (pretreatment)	4.95 ms^2 Standard Deviation 0.96	4.92 ms^2 Standard Deviation 1.05	4.98 ms^2 Standard Deviation 1.07
Child Physiological Regulation Child RSA during clean-up task (postreatment)	4.73 ms^2 Standard Deviation 1.18	4.79 ms^2 Standard Deviation 1.22	4.67 ms^2 Standard Deviation 1.21
Child Physiological Regulation Child RSA during Social Engagement task with parent (pretreatment)	6.10 ms^2 Standard Deviation 1.14	5.95 ms^2 Standard Deviation 1.23	5.98 ms^2 Standard Deviation 1.23
Child Physiological Regulation Child RSA during Social Engagement task with parent (postreatment)	5.91 ms^2 Standard Deviation 1.11	6.05 ms^2 Standard Deviation 1.11	5.96 ms^2 Standard Deviation 1.09

OTHER_PRE_SPECIFIED outcome

Timeframe: pre- and post-intervention (8 months)

Population: These are CHILD scores.

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

Outcome measures

Outcome measures
Measure	Services As Usual (SAU) n=84 Participants Participants receive all the usual services provided by Department of Human Services (DHS) Children's Services.	Parent Child Interaction Therapy (PCIT) n=120 Participants All participants randomized to PCIT condition. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.	Parent Child Interaction Therapy (PCIT) (Engagers Only) n=79 Participants All participants randomized to PCIT condition who engaged in 1+ sessions. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.
Decreased Child Symptoms Anxiety (post-treatment)	54.23 t-scores Standard Deviation 9.55	57.92 t-scores Standard Deviation 14.50	58.78 t-scores Standard Deviation 14.53
Decreased Child Symptoms PTS-Arousal (pre-treatment)	58.80 t-scores Standard Deviation 13.74	59.70 t-scores Standard Deviation 14.34	61.51 t-scores Standard Deviation 14.72
Decreased Child Symptoms PTS-Arousal (post-treatment)	58.35 t-scores Standard Deviation 14.17	57.05 t-scores Standard Deviation 13.51	57.32 t-scores Standard Deviation 13.83
Decreased Child Symptoms PTS-Avoidance (pre-treatment)	57.08 t-scores Standard Deviation 15.33	59.04 t-scores Standard Deviation 18.55	60.94 t-scores Standard Deviation 19.05
Decreased Child Symptoms PTS-Avoidance (post-treatment)	56.96 t-scores Standard Deviation 15.93	55.97 t-scores Standard Deviation 16.63	57.84 t-scores Standard Deviation 18.18
Decreased Child Symptoms PTS-Intrusion (pre-treatment)	57.47 t-scores Standard Deviation 14.62	58.98 t-scores Standard Deviation 16.98	61.65 t-scores Standard Deviation 17.52
Decreased Child Symptoms PTS-Intrusion (post-treatment)	53.95 t-scores Standard Deviation 10.83	56.00 t-scores Standard Deviation 14.12	57.81 t-scores Standard Deviation 15.75
Decreased Child Symptoms Anxiety (pre-treatment)	55.33 t-scores Standard Deviation 10.59	59.25 t-scores Standard Deviation 14.50	60.96 t-scores Standard Deviation 14.10

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Services As Usual (SAU) n=84 Participants Participants receive all the usual services provided by Department of Human Services (DHS) Children's Services.	Parent Child Interaction Therapy (PCIT) n=120 Participants All participants randomized to PCIT condition. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.	Parent Child Interaction Therapy (PCIT) (Engagers Only) n=79 Participants All participants randomized to PCIT condition who engaged in 1+ sessions. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.
Eyberg Child Behavior Inventory (ECBI) Child Behavior Problem Scores (Decreased Disruptive Behavior Problems) ECBI-Number child behavior problems (post-treatment)	56.13 T-scores Standard Deviation 10.95	50.43 T-scores Standard Deviation 9.67	50.46 T-scores Standard Deviation 9.93
Eyberg Child Behavior Inventory (ECBI) Child Behavior Problem Scores (Decreased Disruptive Behavior Problems) ECBI-Intensity child behavior problems (pre-treatment)	58.61 T-scores Standard Deviation 10.79	56.33 T-scores Standard Deviation 10.38	57.56 T-scores Standard Deviation 10.65
Eyberg Child Behavior Inventory (ECBI) Child Behavior Problem Scores (Decreased Disruptive Behavior Problems) ECBI-Intensity child behavior problems (post-treatment)	57.01 T-scores Standard Deviation 9.31	51.35 T-scores Standard Deviation 9.85	50.39 T-scores Standard Deviation 9.94
Eyberg Child Behavior Inventory (ECBI) Child Behavior Problem Scores (Decreased Disruptive Behavior Problems) ECBI-Number child behavior problems (pre-treatment)	58.64 T-scores Standard Deviation 11.79	55.74 T-scores Standard Deviation 11.08	57.00 T-scores Standard Deviation 11.46

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Services As Usual (SAU) n=84 Participants Participants receive all the usual services provided by Department of Human Services (DHS) Children's Services.	Parent Child Interaction Therapy (PCIT) n=120 Participants All participants randomized to PCIT condition. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.	Parent Child Interaction Therapy (PCIT) (Engagers Only) n=79 Participants All participants randomized to PCIT condition who engaged in 1+ sessions. Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.
BRIEF-A: Parent Self-ratings Inhibition problems (pre-treatment)	55.15 T-scores Standard Deviation 10.27	55.92 T-scores Standard Deviation 9.93	55.95 T-scores Standard Deviation 9.87
BRIEF-A: Parent Self-ratings Emotional control problems (pretreatment)	52.57 T-scores Standard Deviation 9.18	53.95 T-scores Standard Deviation 10.87	55.06 T-scores Standard Deviation 11.38
BRIEF-A: Parent Self-ratings Emotional control problems (posttreatment)	54.95 T-scores Standard Deviation 11.21	52.72 T-scores Standard Deviation 11.03	53.33 T-scores Standard Deviation 10.97
BRIEF-A: Parent Self-ratings Inhibition problems (post-treatment)	55.32 T-scores Standard Deviation 9.99	54.41 T-scores Standard Deviation 9.81	54.33 T-scores Standard Deviation 9.74
BRIEF-A: Parent Self-ratings Initiate problems (pre)	52.50 T-scores Standard Deviation 10.87	54.33 T-scores Standard Deviation 10.95	54.51 T-scores Standard Deviation 10.63
BRIEF-A: Parent Self-ratings Initiate problems (post)	53.83 T-scores Standard Deviation 12.46	52.18 T-scores Standard Deviation 10.97	52.93 T-scores Standard Deviation 10.85
BRIEF-A: Parent Self-ratings Monitor problems (pretreatment)	50.93 T-scores Standard Deviation 10.10	52.48 T-scores Standard Deviation 10.06	53.19 T-scores Standard Deviation 10.57
BRIEF-A: Parent Self-ratings Monitor problems (posttreatment)	52.24 T-scores Standard Deviation 11.27	51.35 T-scores Standard Deviation 9.85	51.46 T-scores Standard Deviation 9.53

Adverse Events

Services As Usual (SAU) - Parents

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Services As Usual (SAU) - Children

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Parent Child Interaction Therapy (PCIT) - Parents

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Parent Child Interaction Therapy (PCIT) - Children

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Parent-Child Interaction Therapy (PCIT) Engagers Only - Parents

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Parent-Child Interaction Therapy (PCIT) Engagers Only - Children

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Elizabeth Skowron

University of Oregon

Phone: 541-346-9329

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Services As Usual (SAU) n=168 Participants Participants receive all the usual services provided by DHS- Children's Services.	Parent Child Interaction Therapy (PCIT) n=240 Participants Participants randomized to receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. 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.	Total n=408 Participants Total of all reporting groups
Age, Continuous	32.12 years STANDARD_DEVIATION 5.82 • n=84 Participants • Only the 204 parents' age data were included in this analysis.	32.41 years STANDARD_DEVIATION 6.70 • n=120 Participants • Only the 204 parents' age data were included in this analysis.	32.29 years STANDARD_DEVIATION 6.34 • n=204 Participants • Only the 204 parents' age data were included in this analysis.
Sex: Female, Male Female	73 Participants n=84 Participants • Only PARENT sex is included in this analysis.	107 Participants n=120 Participants • Only PARENT sex is included in this analysis.	180 Participants n=204 Participants • Only PARENT sex is included in this analysis.
Sex: Female, Male Male	11 Participants n=84 Participants • Only PARENT sex is included in this analysis.	13 Participants n=120 Participants • Only PARENT sex is included in this analysis.	24 Participants n=204 Participants • Only PARENT sex is included in this analysis.
Race/Ethnicity, Customized PARENT participants · European American/White	62 Participants n=84 Participants • PARENT and CHILD data are reported in separate sections below.	82 Participants n=120 Participants • PARENT and CHILD data are reported in separate sections below.	144 Participants n=204 Participants • PARENT and CHILD data are reported in separate sections below.
Race/Ethnicity, Customized PARENT participants · Multiracial/Multiethnic	15 Participants n=84 Participants • PARENT and CHILD data are reported in separate sections below.	27 Participants n=120 Participants • PARENT and CHILD data are reported in separate sections below.	42 Participants n=204 Participants • PARENT and CHILD data are reported in separate sections below.
Race/Ethnicity, Customized PARENT participants · Hispanic American/Latinx	2 Participants n=84 Participants • PARENT and CHILD data are reported in separate sections below.	3 Participants n=120 Participants • PARENT and CHILD data are reported in separate sections below.	5 Participants n=204 Participants • PARENT and CHILD data are reported in separate sections below.
Race/Ethnicity, Customized PARENT participants · African American/Black	2 Participants n=84 Participants • PARENT and CHILD data are reported in separate sections below.	2 Participants n=120 Participants • PARENT and CHILD data are reported in separate sections below.	4 Participants n=204 Participants • PARENT and CHILD data are reported in separate sections below.
Race/Ethnicity, Customized PARENT participants · Asian/Pacific Islander	0 Participants n=84 Participants • PARENT and CHILD data are reported in separate sections below.	3 Participants n=120 Participants • PARENT and CHILD data are reported in separate sections below.	3 Participants n=204 Participants • PARENT and CHILD data are reported in separate sections below.
Race/Ethnicity, Customized PARENT participants · Native American/Alaskan Aleutian	2 Participants n=84 Participants • PARENT and CHILD data are reported in separate sections below.	1 Participants n=120 Participants • PARENT and CHILD data are reported in separate sections below.	3 Participants n=204 Participants • PARENT and CHILD data are reported in separate sections below.
Race/Ethnicity, Customized PARENT participants · Not reported	1 Participants n=84 Participants • PARENT and CHILD data are reported in separate sections below.	2 Participants n=120 Participants • PARENT and CHILD data are reported in separate sections below.	3 Participants n=204 Participants • PARENT and CHILD data are reported in separate sections below.
Race/Ethnicity, Customized CHILD participants · European American/White	49 Participants n=84 Participants • PARENT and CHILD data are reported in separate sections below.	68 Participants n=120 Participants • PARENT and CHILD data are reported in separate sections below.	117 Participants n=204 Participants • PARENT and CHILD data are reported in separate sections below.
Race/Ethnicity, Customized CHILD participants · Multiracial/Multiethnic	27 Participants n=84 Participants • PARENT and CHILD data are reported in separate sections below.	46 Participants n=120 Participants • PARENT and CHILD data are reported in separate sections below.	73 Participants n=204 Participants • PARENT and CHILD data are reported in separate sections below.
Race/Ethnicity, Customized CHILD participants · Hispanic American/Latinx	3 Participants n=84 Participants • PARENT and CHILD data are reported in separate sections below.	3 Participants n=120 Participants • PARENT and CHILD data are reported in separate sections below.	6 Participants n=204 Participants • PARENT and CHILD data are reported in separate sections below.
Race/Ethnicity, Customized CHILD participants · African American/Black	2 Participants n=84 Participants • PARENT and CHILD data are reported in separate sections below.	1 Participants n=120 Participants • PARENT and CHILD data are reported in separate sections below.	3 Participants n=204 Participants • PARENT and CHILD data are reported in separate sections below.
Race/Ethnicity, Customized CHILD participants · Asian/Pacific Islander	0 Participants n=84 Participants • PARENT and CHILD data are reported in separate sections below.	0 Participants n=120 Participants • PARENT and CHILD data are reported in separate sections below.	0 Participants n=204 Participants • PARENT and CHILD data are reported in separate sections below.
Race/Ethnicity, Customized CHILD participants · Native American/Alaskan Aleutian	1 Participants n=84 Participants • PARENT and CHILD data are reported in separate sections below.	1 Participants n=120 Participants • PARENT and CHILD data are reported in separate sections below.	2 Participants n=204 Participants • PARENT and CHILD data are reported in separate sections below.
Race/Ethnicity, Customized CHILD participants · Not reported	2 Participants n=84 Participants • PARENT and CHILD data are reported in separate sections below.	1 Participants n=120 Participants • PARENT and CHILD data are reported in separate sections below.	3 Participants n=204 Participants • PARENT and CHILD data are reported in separate sections below.
Participating child age (years)	4.8 years STANDARD_DEVIATION 1.4 • n=84 Participants • Only the CHILD participants' ages were included in this analysis.	4.7 years STANDARD_DEVIATION 1.4 • n=120 Participants • Only the CHILD participants' ages were included in this analysis.	4.8 years STANDARD_DEVIATION 1.4 • n=204 Participants • Only the CHILD participants' ages were included in this analysis.
Participating child sex Male children	50 Participants n=84 Participants • Only CHILD sex is included in this analysis.	62 Participants n=120 Participants • Only CHILD sex is included in this analysis.	112 Participants n=204 Participants • Only CHILD sex is included in this analysis.
Participating child sex Female children	34 Participants n=84 Participants • Only CHILD sex is included in this analysis.	58 Participants n=120 Participants • Only CHILD sex is included in this analysis.	92 Participants n=204 Participants • Only CHILD sex is included in this analysis.
Parent education Less than high school education	14 Participants n=84 Participants • Only PARENT education levels are included in this analysis.	20 Participants n=120 Participants • Only PARENT education levels are included in this analysis.	34 Participants n=204 Participants • Only PARENT education levels are included in this analysis.
Parent education High school education	43 Participants n=84 Participants • Only PARENT education levels are included in this analysis.	58 Participants n=120 Participants • Only PARENT education levels are included in this analysis.	101 Participants n=204 Participants • Only PARENT education levels are included in this analysis.
Parent education Post-high school education	27 Participants n=84 Participants • Only PARENT education levels are included in this analysis.	42 Participants n=120 Participants • Only PARENT education levels are included in this analysis.	69 Participants n=204 Participants • Only PARENT education levels are included in this analysis.
Marital status Single	64 Participants n=84 Participants • Only PARENT marital status is included here.	74 Participants n=120 Participants • Only PARENT marital status is included here.	138 Participants n=204 Participants • Only PARENT marital status is included here.
Marital status Married or living together	20 Participants n=84 Participants • Only PARENT marital status is included here.	46 Participants n=120 Participants • Only PARENT marital status is included here.	66 Participants n=204 Participants • Only PARENT marital status is included here.