Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-01-04 @ 8:38 AM
Study NCT ID:
NCT02684903
Status:
COMPLETED
Last Update Posted:
2023-11-02
First Post:
2016-02-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Coaching Alternative Parenting Strategies (CAPS) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000068356', 'term': 'Self-Control'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eskowron@uoregon.edu', 'phone': '541-346-9329', 'title': 'Dr. Elizabeth Skowron', 'organization': 'University of Oregon'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected during the time frame encompassing data collection, from participant study entry through study completion, an average of 8 months.', 'description': 'Our definition of adverse event is consistent with clinicaltrials.gov, and is "an untoward or unfavorable medical occurrence in a study participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant\'s participation in the research." No adverse events occurred in this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Services As Usual (SAU) - Parents', 'description': "Participants receive all the usual services provided by DHS- Children's Services.", 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 0, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Services As Usual (SAU) - Children', 'description': "Participants receive all the usual services provided by DHS- Children's Services.", 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 0, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Parent Child Interaction Therapy (PCIT) - Parents', 'description': "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.\n\nParent 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.", 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 0, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Parent Child Interaction Therapy (PCIT) - Children', 'description': "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.\n\nParent 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.", 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 0, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Parent-Child Interaction Therapy (PCIT) Engagers Only - Parents', 'description': 'All participants randomized to PCIT condition who engaged in 1+ sessions.', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 0, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Parent-Child Interaction Therapy (PCIT) Engagers Only - Children', 'description': 'All participants randomized to PCIT condition who engaged in 1+ sessions.', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 0, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'DPICS-IV Observed Parenting Skills (During Child-Led Play)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Services As Usual (SAU)', 'description': "Participants receive all the usual services provided by Department of Human Services (DHS) Children's Services."}, {'id': 'OG001', 'title': 'Parent Child Interaction Therapy (PCIT)', 'description': "All participants randomized to PCIT condition.\n\nParticipants 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.\n\nParent 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."}, {'id': 'OG002', 'title': 'Parent Child Interaction Therapy (PCIT) (Engagers Only)', 'description': "All participants randomized to PCIT condition who engaged in 1+ sessions.\n\nParticipants 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.\n\nParent 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."}], 'classes': [{'title': 'Positive Parenting "PRIDE" skills (pre-treatment)', 'categories': [{'measurements': [{'value': '2.32', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '2.63', 'spread': '2.92', 'groupId': 'OG001'}, {'value': '2.86', 'spread': '3.10', 'groupId': 'OG002'}]}]}, {'title': 'Positive Parenting "PRIDE" skills (post-treatment)', 'categories': [{'measurements': [{'value': '2.11', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '8.01', 'spread': '9.61', 'groupId': 'OG001'}, {'value': '10.19', 'spread': '10.47', 'groupId': 'OG002'}]}]}, {'title': 'Negative Parenting "Don\'t" skills (pre-treatment)', 'categories': [{'measurements': [{'value': '23.62', 'spread': '11.66', 'groupId': 'OG000'}, {'value': '23.61', 'spread': '11.78', 'groupId': 'OG001'}, {'value': '24.16', 'spread': '11.92', 'groupId': 'OG002'}]}]}, {'title': 'Negative Parenting "Don\'t" skills (post-treatment)', 'categories': [{'measurements': [{'value': '21.80', 'spread': '11.31', 'groupId': 'OG000'}, {'value': '14.82', 'spread': '9.99', 'groupId': 'OG001'}, {'value': '13.30', 'spread': '9.42', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre- and Post-intervention (8 months)', 'description': '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.', 'unitOfMeasure': 'number of behaviors', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'DPICS-IV Observational Coding During Clean Up Situation Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Services As Usual (SAU)', 'description': "Participants receive all the usual services provided by DHS- Children's Services."}, {'id': 'OG001', 'title': 'Parent Child Interaction Therapy (PCIT)', 'description': "All participants randomized to PCIT condition.\n\nParticipants 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.\n\nParent 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."}, {'id': 'OG002', 'title': 'Parent Child Interaction Therapy (PCIT) (Engagers Only)', 'description': "All participants randomized to PCIT condition who engaged in 1+ sessions.\n\nParticipants 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.\n\nParent 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."}], 'classes': [{'title': 'Effective commands (pre-treatment)', 'categories': [{'measurements': [{'value': '0.56', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '0.53', 'spread': '0.24', 'groupId': 'OG002'}]}]}, {'title': 'Effective commands (post-treatment)', 'categories': [{'measurements': [{'value': '0.63', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.60', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '0.59', 'spread': '0.29', 'groupId': 'OG002'}]}]}, {'title': 'Child compliance with parent commands (pre-treatment)', 'categories': [{'measurements': [{'value': '0.69', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '0.71', 'spread': '0.31', 'groupId': 'OG002'}]}]}, {'title': 'Child compliance with parent commands (post-treatment)', 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '0.75', 'spread': '0.31', 'groupId': 'OG002'}]}]}, {'title': 'Positive Parenting "PRIDE" skills (pre-treatment)', 'categories': [{'measurements': [{'value': '0.65', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '0.63', 'spread': '0.28', 'groupId': 'OG002'}]}]}, {'title': 'Positive Parenting "PRIDE" skills (post-treatment)', 'categories': [{'measurements': [{'value': '0.69', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '0.71', 'spread': '0.31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre- and Post-intervention (8 months)', 'description': '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.', 'unitOfMeasure': 'percentage of all parenting behaviors', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Stop Signal Task: Increased Parent Inhibitory Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Services As Usual (SAU)', 'description': "Participants receive all the usual services provided by DHS- Children's Services."}, {'id': 'OG001', 'title': 'Parent Child Interaction Therapy (PCIT)', 'description': "All participants randomized to PCIT condition.\n\nParticipants 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.\n\nParent 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."}, {'id': 'OG002', 'title': 'Parent Child Interaction Therapy (PCIT) (Engagers Only)', 'description': "All participants randomized to PCIT condition who engaged in 1+ sessions.\n\nParticipants 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.\n\nParent 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."}], 'classes': [{'title': 'Stop signal response time (SSRT) (pre-treatment)', 'categories': [{'measurements': [{'value': '252.84', 'spread': '68.07', 'groupId': 'OG000'}, {'value': '248.25', 'spread': '54.40', 'groupId': 'OG001'}, {'value': '251.44', 'spread': '58.18', 'groupId': 'OG002'}]}]}, {'title': 'Stop signal response time (SSRT) (post-treatment)', 'categories': [{'measurements': [{'value': '255.16', 'spread': '57.94', 'groupId': 'OG000'}, {'value': '237.45', 'spread': '47.89', 'groupId': 'OG001'}, {'value': '236.28', 'spread': '45.33', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre- and post-intervention (8 months)', 'description': '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.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Reduced Child Maltreatment (CM) Recidivism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Services As Usual (SAU)', 'description': "Participants receive all the usual services provided by Department of Human Services (DHS) Children's Services."}, {'id': 'OG001', 'title': 'Parent Child Interaction Therapy (PCIT)', 'description': "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.\n\n.\n\nParent 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."}], 'timeFrame': 'up to 1 year posttreatment', 'description': 'Fewer new episodes of CM per Maltreatment Classification Coding of Child Welfare case records', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'BRIEF-A: Emotional Control Scale (Increased Parent Emotion Regulation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Services As Usual (SAU)', 'description': "Participants receive all the usual services provided by DHS- Children's Services."}, {'id': 'OG001', 'title': 'Parent Child Interaction Therapy (PCIT)', 'description': "All participants randomized to PCIT condition.\n\nParticipants 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.\n\nParent 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."}, {'id': 'OG002', 'title': 'Parent Child Interaction Therapy (PCIT) (Engagers Only)', 'description': "All participants randomized to PCIT condition who engaged in 1+ sessions.\n\nParticipants 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.\n\nParent 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."}], 'classes': [{'title': 'Emotional Control problems (pre-treatment)', 'categories': [{'measurements': [{'value': '52.57', 'spread': '9.18', 'groupId': 'OG000'}, {'value': '53.95', 'spread': '10.87', 'groupId': 'OG001'}, {'value': '55.06', 'spread': '11.38', 'groupId': 'OG002'}]}]}, {'title': 'Emotional Control problems (post-treatment)', 'categories': [{'measurements': [{'value': '54.95', 'spread': '11.21', 'groupId': 'OG000'}, {'value': '52.72', 'spread': '11.03', 'groupId': 'OG001'}, {'value': '53.33', 'spread': '10.97', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre- and post-intervention (8 months)', 'description': '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.', 'unitOfMeasure': 'T-scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "BRIEF (Behavioral Rating Inventory of Executive Function) Children's Outcomes", 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Services As Usual (SAU)', 'description': "Participants receive all the usual services provided by DHS- Children's Services."}, {'id': 'OG001', 'title': 'Parent Child Interaction Therapy (PCIT)', 'description': "All participants randomized to PCIT condition.\n\nParticipants 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.\n\nParent 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."}, {'id': 'OG002', 'title': 'Parent Child Interaction Therapy (PCIT) (Engagers Only)', 'description': "All participants randomized to PCIT condition who engaged in 1+ sessions.\n\nParticipants 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.\n\nParent 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."}], 'classes': [{'title': 'Inhibition problems (pre-treatment)', 'categories': [{'measurements': [{'value': '59.11', 'spread': '12.00', 'groupId': 'OG000'}, {'value': '58.36', 'spread': '12.34', 'groupId': 'OG001'}, {'value': '59.84', 'spread': '11.76', 'groupId': 'OG002'}]}]}, {'title': 'Inhibition problems (post-treatment)', 'categories': [{'measurements': [{'value': '60.12', 'spread': '11.72', 'groupId': 'OG000'}, {'value': '57.98', 'spread': '10.88', 'groupId': 'OG001'}, {'value': '58.55', 'spread': '10.92', 'groupId': 'OG002'}]}]}, {'title': 'Shift problems (pretreatment)', 'categories': [{'measurements': [{'value': '54.86', 'spread': '13.08', 'groupId': 'OG000'}, {'value': '57.10', 'spread': '11.55', 'groupId': 'OG001'}, {'value': '58.63', 'spread': '11.07', 'groupId': 'OG002'}]}]}, {'title': 'Shift problems (posttreatment)', 'categories': [{'measurements': [{'value': '55.46', 'spread': '12.95', 'groupId': 'OG000'}, {'value': '55.27', 'spread': '10.89', 'groupId': 'OG001'}, {'value': '55.90', 'spread': '10.94', 'groupId': 'OG002'}]}]}, {'title': 'Emotional control problems (pretreatment)', 'categories': [{'measurements': [{'value': '54.30', 'spread': '12.58', 'groupId': 'OG000'}, {'value': '54.79', 'spread': '11.76', 'groupId': 'OG001'}, {'value': '56.09', 'spread': '12.07', 'groupId': 'OG002'}]}]}, {'title': 'Emotional control problems (posttreatment)', 'categories': [{'measurements': [{'value': '54.42', 'spread': '10.30', 'groupId': 'OG000'}, {'value': '52.87', 'spread': '11.14', 'groupId': 'OG001'}, {'value': '53.03', 'spread': '11.49', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre- and post-intervention', 'description': "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.", 'unitOfMeasure': 'T-scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Parent Physiological Regulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Services As Usual (SAU)', 'description': "Participants receive all the usual services provided by Department of Human Services (DHS) Children's Services."}, {'id': 'OG001', 'title': 'Parent Child Interaction Therapy (PCIT)', 'description': "All participants randomized to PCIT condition.\n\nParticipants 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.\n\nParent 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."}, {'id': 'OG002', 'title': 'Parent Child Interaction Therapy (PCIT) (Engagers Only)', 'description': "All participants randomized to PCIT condition who engaged in 1+ sessions.\n\nParticipants 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.\n\nParent 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."}], 'classes': [{'title': 'Parent Resting RSA (at pretreatment)', 'categories': [{'measurements': [{'value': '6.30', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '5.97', 'spread': '1.45', 'groupId': 'OG001'}, {'value': '5.88', 'spread': '1.53', 'groupId': 'OG002'}]}]}, {'title': 'Parent Resting RSA (at posttreatment)', 'categories': [{'measurements': [{'value': '5.77', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '5.57', 'spread': '1.71', 'groupId': 'OG001'}, {'value': '5.35', 'spread': '1.71', 'groupId': 'OG002'}]}]}, {'title': 'Parent RSA during DPICS Child-Led Play Task (pretreatment)', 'categories': [{'measurements': [{'value': '5.99', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '5.76', 'spread': '1.37', 'groupId': 'OG001'}, {'value': '5.67', 'spread': '1.44', 'groupId': 'OG002'}]}]}, {'title': 'Parent RSA during DPICS Child-Led Play Task (posttreatment)', 'categories': [{'measurements': [{'value': '5.57', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '5.58', 'spread': '1.54', 'groupId': 'OG001'}, {'value': '5.52', 'spread': '1.57', 'groupId': 'OG002'}]}]}, {'title': 'Parent RSA during DPICS Clean Up Task (pretreatment)', 'categories': [{'measurements': [{'value': '6.05', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '5.79', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '5.71', 'spread': '1.32', 'groupId': 'OG002'}]}]}, {'title': 'Parent RSA during DPICS Clean Up Task (posttreatment)', 'categories': [{'measurements': [{'value': '5.81', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '5.51', 'spread': '1.39', 'groupId': 'OG001'}, {'value': '5.41', 'spread': '1.43', 'groupId': 'OG002'}]}]}, {'title': 'Parent RSA during Social Engagement task (pretreatment)', 'categories': [{'measurements': [{'value': '6.51', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '6.19', 'spread': '1.36', 'groupId': 'OG001'}, {'value': '6.02', 'spread': '1.43', 'groupId': 'OG002'}]}]}, {'title': 'Parent RSA during Social Engagement task (posttreatment)', 'categories': [{'measurements': [{'value': '6.27', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '5.98', 'spread': '1.46', 'groupId': 'OG001'}, {'value': '5.85', 'spread': '1.47', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre- and post-intervention', 'description': "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).", 'unitOfMeasure': 'ms^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Child Emotion Regulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Services As Usual (SAU)', 'description': "Participants receive all the usual services provided by Department of Human Services (DHS) Children's Services."}, {'id': 'OG001', 'title': 'Parent Child Interaction Therapy (PCIT)', 'description': "All participants randomized to PCIT condition.\n\nParticipants 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.\n\nParent 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."}, {'id': 'OG002', 'title': 'Parent Child Interaction Therapy (PCIT) (Engagers Only)', 'description': "All participants randomized to PCIT condition who engaged in 1+ sessions.\n\nParticipants 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.\n\nParent 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."}], 'classes': [{'title': 'Child False Alarms to Anger (pretreatment)', 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '0.41', 'spread': '0.31', 'groupId': 'OG002'}]}]}, {'title': 'Child False Alarms to Anger (posttreatment)', 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '0.35', 'spread': '0.24', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post intervention (6 mo)', 'description': 'Emotional go/no-go task performance: False alarms to anger. Higher scores reflect greater rate of false alarms to anger (worse outcome).', 'unitOfMeasure': 'percentage of responses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Child Physiological Regulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Services As Usual (SAU)', 'description': "Participants receive all the usual services provided by Department of Human Services (DHS) Children's Services."}, {'id': 'OG001', 'title': 'Parent Child Interaction Therapy (PCIT)', 'description': "All participants randomized to PCIT condition.\n\nParticipants 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.\n\nParent 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."}, {'id': 'OG002', 'title': 'Parent Child Interaction Therapy (PCIT) (Engagers Only)', 'description': "All participants randomized to PCIT condition who engaged in 1+ sessions.\n\nParticipants 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.\n\nParent 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."}], 'classes': [{'title': 'Child resting RSA (pretreatment)', 'categories': [{'measurements': [{'value': '6.68', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '6.41', 'spread': '1.40', 'groupId': 'OG001'}, {'value': '6.48', 'spread': '1.34', 'groupId': 'OG002'}]}]}, {'title': 'Child resting RSA (postreatment)', 'categories': [{'measurements': [{'value': '6.36', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '6.47', 'spread': '1.31', 'groupId': 'OG001'}, {'value': '6.35', 'spread': '1.25', 'groupId': 'OG002'}]}]}, {'title': 'Child RSA during child-led play task (pretreatment)', 'categories': [{'measurements': [{'value': '5.40', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '5.38', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '5.42', 'spread': '1.12', 'groupId': 'OG002'}]}]}, {'title': 'Child RSA during child-led play task (posttreatment)', 'categories': [{'measurements': [{'value': '5.28', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '5.33', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '5.29', 'spread': '1.18', 'groupId': 'OG002'}]}]}, {'title': 'Child RSA during clean-up task (pretreatment)', 'categories': [{'measurements': [{'value': '4.95', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '4.92', 'spread': '1.05', 'groupId': 'OG001'}, {'value': '4.98', 'spread': '1.07', 'groupId': 'OG002'}]}]}, {'title': 'Child RSA during clean-up task (postreatment)', 'categories': [{'measurements': [{'value': '4.73', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '4.79', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '4.67', 'spread': '1.21', 'groupId': 'OG002'}]}]}, {'title': 'Child RSA during Social Engagement task with parent (pretreatment)', 'categories': [{'measurements': [{'value': '6.10', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '5.95', 'spread': '1.23', 'groupId': 'OG001'}, {'value': '5.98', 'spread': '1.23', 'groupId': 'OG002'}]}]}, {'title': 'Child RSA during Social Engagement task with parent (postreatment)', 'categories': [{'measurements': [{'value': '5.91', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '6.05', 'spread': '1.11', 'groupId': 'OG001'}, {'value': '5.96', 'spread': '1.09', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre- and post-intervention (8 months)', 'description': "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).", 'unitOfMeasure': 'ms^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'CHILD RSA data reported here'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Decreased Child Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Services As Usual (SAU)', 'description': "Participants receive all the usual services provided by DHS- Children's Services."}, {'id': 'OG001', 'title': 'Parent Child Interaction Therapy (PCIT)', 'description': "All participants randomized to PCIT condition.\n\nParticipants 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.\n\nParent 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."}, {'id': 'OG002', 'title': 'Parent Child Interaction Therapy (PCIT) (Engagers Only)', 'description': "All participants randomized to PCIT condition who engaged in 1+ sessions.\n\nParticipants 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.\n\nParent 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."}], 'classes': [{'title': 'PTS-Arousal (pre-treatment)', 'categories': [{'measurements': [{'value': '58.80', 'spread': '13.74', 'groupId': 'OG000'}, {'value': '59.70', 'spread': '14.34', 'groupId': 'OG001'}, {'value': '61.51', 'spread': '14.72', 'groupId': 'OG002'}]}]}, {'title': 'PTS-Arousal (post-treatment)', 'categories': [{'measurements': [{'value': '58.35', 'spread': '14.17', 'groupId': 'OG000'}, {'value': '57.05', 'spread': '13.51', 'groupId': 'OG001'}, {'value': '57.32', 'spread': '13.83', 'groupId': 'OG002'}]}]}, {'title': 'PTS-Avoidance (pre-treatment)', 'categories': [{'measurements': [{'value': '57.08', 'spread': '15.33', 'groupId': 'OG000'}, {'value': '59.04', 'spread': '18.55', 'groupId': 'OG001'}, {'value': '60.94', 'spread': '19.05', 'groupId': 'OG002'}]}]}, {'title': 'PTS-Avoidance (post-treatment)', 'categories': [{'measurements': [{'value': '56.96', 'spread': '15.93', 'groupId': 'OG000'}, {'value': '55.97', 'spread': '16.63', 'groupId': 'OG001'}, {'value': '57.84', 'spread': '18.18', 'groupId': 'OG002'}]}]}, {'title': 'PTS-Intrusion (pre-treatment)', 'categories': [{'measurements': [{'value': '57.47', 'spread': '14.62', 'groupId': 'OG000'}, {'value': '58.98', 'spread': '16.98', 'groupId': 'OG001'}, {'value': '61.65', 'spread': '17.52', 'groupId': 'OG002'}]}]}, {'title': 'PTS-Intrusion (post-treatment)', 'categories': [{'measurements': [{'value': '53.95', 'spread': '10.83', 'groupId': 'OG000'}, {'value': '56.00', 'spread': '14.12', 'groupId': 'OG001'}, {'value': '57.81', 'spread': '15.75', 'groupId': 'OG002'}]}]}, {'title': 'Anxiety (pre-treatment)', 'categories': [{'measurements': [{'value': '55.33', 'spread': '10.59', 'groupId': 'OG000'}, {'value': '59.25', 'spread': '14.50', 'groupId': 'OG001'}, {'value': '60.96', 'spread': '14.10', 'groupId': 'OG002'}]}]}, {'title': 'Anxiety (post-treatment)', 'categories': [{'measurements': [{'value': '54.23', 'spread': '9.55', 'groupId': 'OG000'}, {'value': '57.92', 'spread': '14.50', 'groupId': 'OG001'}, {'value': '58.78', 'spread': '14.53', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre- and post-intervention (8 months)', 'description': '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', 'unitOfMeasure': 't-scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'These are CHILD scores.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Eyberg Child Behavior Inventory (ECBI) Child Behavior Problem Scores (Decreased Disruptive Behavior Problems)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Services As Usual (SAU)', 'description': "Participants receive all the usual services provided by DHS- Children's Services."}, {'id': 'OG001', 'title': 'Parent Child Interaction Therapy (PCIT)', 'description': "All participants randomized to PCIT condition.\n\nParticipants 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.\n\nParent 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."}, {'id': 'OG002', 'title': 'Parent Child Interaction Therapy (PCIT) (Engagers Only)', 'description': "All participants randomized to PCIT condition who engaged in 1+ sessions.\n\nParticipants 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.\n\nParent 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."}], 'classes': [{'title': 'ECBI-Intensity child behavior problems (pre-treatment)', 'categories': [{'measurements': [{'value': '58.61', 'spread': '10.79', 'groupId': 'OG000'}, {'value': '56.33', 'spread': '10.38', 'groupId': 'OG001'}, {'value': '57.56', 'spread': '10.65', 'groupId': 'OG002'}]}]}, {'title': 'ECBI-Intensity child behavior problems (post-treatment)', 'categories': [{'measurements': [{'value': '57.01', 'spread': '9.31', 'groupId': 'OG000'}, {'value': '51.35', 'spread': '9.85', 'groupId': 'OG001'}, {'value': '50.39', 'spread': '9.94', 'groupId': 'OG002'}]}]}, {'title': 'ECBI-Number child behavior problems (pre-treatment)', 'categories': [{'measurements': [{'value': '58.64', 'spread': '11.79', 'groupId': 'OG000'}, {'value': '55.74', 'spread': '11.08', 'groupId': 'OG001'}, {'value': '57.00', 'spread': '11.46', 'groupId': 'OG002'}]}]}, {'title': 'ECBI-Number child behavior problems (post-treatment)', 'categories': [{'measurements': [{'value': '56.13', 'spread': '10.95', 'groupId': 'OG000'}, {'value': '50.43', 'spread': '9.67', 'groupId': 'OG001'}, {'value': '50.46', 'spread': '9.93', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre- and post-intervention (8 months)', 'description': '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.', 'unitOfMeasure': 'T-scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'BRIEF-A: Parent Self-ratings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Services As Usual (SAU)', 'description': "Participants receive all the usual services provided by DHS- Children's Services."}, {'id': 'OG001', 'title': 'Parent Child Interaction Therapy (PCIT)', 'description': "All participants randomized to PCIT condition.\n\nParticipants 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.\n\nParent 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."}, {'id': 'OG002', 'title': 'Parent Child Interaction Therapy (PCIT) (Engagers Only)', 'description': "All participants randomized to PCIT condition who engaged in 1+ sessions.\n\nParticipants 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.\n\nParent 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."}], 'classes': [{'title': 'Emotional control problems (pretreatment)', 'categories': [{'measurements': [{'value': '52.57', 'spread': '9.18', 'groupId': 'OG000'}, {'value': '53.95', 'spread': '10.87', 'groupId': 'OG001'}, {'value': '55.06', 'spread': '11.38', 'groupId': 'OG002'}]}]}, {'title': 'Emotional control problems (posttreatment)', 'categories': [{'measurements': [{'value': '54.95', 'spread': '11.21', 'groupId': 'OG000'}, {'value': '52.72', 'spread': '11.03', 'groupId': 'OG001'}, {'value': '53.33', 'spread': '10.97', 'groupId': 'OG002'}]}]}, {'title': 'Inhibition problems (pre-treatment)', 'categories': [{'measurements': [{'value': '55.15', 'spread': '10.27', 'groupId': 'OG000'}, {'value': '55.92', 'spread': '9.93', 'groupId': 'OG001'}, {'value': '55.95', 'spread': '9.87', 'groupId': 'OG002'}]}]}, {'title': 'Inhibition problems (post-treatment)', 'categories': [{'measurements': [{'value': '55.32', 'spread': '9.99', 'groupId': 'OG000'}, {'value': '54.41', 'spread': '9.81', 'groupId': 'OG001'}, {'value': '54.33', 'spread': '9.74', 'groupId': 'OG002'}]}]}, {'title': 'Initiate problems (pre)', 'categories': [{'measurements': [{'value': '52.50', 'spread': '10.87', 'groupId': 'OG000'}, {'value': '54.33', 'spread': '10.95', 'groupId': 'OG001'}, {'value': '54.51', 'spread': '10.63', 'groupId': 'OG002'}]}]}, {'title': 'Initiate problems (post)', 'categories': [{'measurements': [{'value': '53.83', 'spread': '12.46', 'groupId': 'OG000'}, {'value': '52.18', 'spread': '10.97', 'groupId': 'OG001'}, {'value': '52.93', 'spread': '10.85', 'groupId': 'OG002'}]}]}, {'title': 'Monitor problems (pretreatment)', 'categories': [{'measurements': [{'value': '50.93', 'spread': '10.10', 'groupId': 'OG000'}, {'value': '52.48', 'spread': '10.06', 'groupId': 'OG001'}, {'value': '53.19', 'spread': '10.57', 'groupId': 'OG002'}]}]}, {'title': 'Monitor problems (posttreatment)', 'categories': [{'measurements': [{'value': '52.24', 'spread': '11.27', 'groupId': 'OG000'}, {'value': '51.35', 'spread': '9.85', 'groupId': 'OG001'}, {'value': '51.46', 'spread': '9.53', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre- and post-intervention (8 months)', 'description': 'Parents self-report on the BRIEF- A with lower scores reflecting fewer regulatory control problems. Standardized T-scores (M=50, SD = 10) are obtained.', 'unitOfMeasure': 'T-scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Services As Usual (SAU)', 'description': "Participants receive all the usual services provided by DHS- Children's Services."}, {'id': 'FG001', 'title': 'Parent Child Interaction Therapy (PCIT)', 'description': "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.\n\nParent 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."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '(84 parents and 84 children)', 'groupId': 'FG000', 'numSubjects': '168'}, {'comment': '(120 parents and 120 children)', 'groupId': 'FG001', 'numSubjects': '240'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '(68 parents and 65 children)', 'groupId': 'FG000', 'numSubjects': '133'}, {'comment': '(100 parents and 93 children)', 'groupId': 'FG001', 'numSubjects': '193'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'COVID-19 shutdown of lab', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '41'}]}]}], 'preAssignmentDetails': '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).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'BG000'}, {'value': '240', 'groupId': 'BG001'}, {'value': '408', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Services As Usual (SAU)', 'description': "Participants receive all the usual services provided by DHS- Children's Services."}, {'id': 'BG001', 'title': 'Parent Child Interaction Therapy (PCIT)', 'description': "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.\n\nParent 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."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32.12', 'spread': '5.82', 'groupId': 'BG000'}, {'value': '32.41', 'spread': '6.70', 'groupId': 'BG001'}, {'value': '32.29', 'spread': '6.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This is PARENT age in years', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "Only the 204 parents' age data were included in this analysis."}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Parent Sex: Female, Male', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only PARENT sex is included in this analysis.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'PARENT participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'categories': [{'title': 'European American/White', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}, {'title': 'Multiracial/Multiethnic', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Hispanic American/Latinx', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'African American/Black', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian/Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native American/Alaskan Aleutian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'CHILD participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'categories': [{'title': 'European American/White', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'Multiracial/Multiethnic', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Hispanic American/Latinx', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'African American/Black', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian/Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native American/Alaskan Aleutian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'PARENT and CHILD data are reported in separate sections below.'}, {'title': 'Participating child age (years)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '4.7', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '4.8', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "Only the CHILD participants' ages were included in this analysis."}, {'title': 'Participating child sex', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Male children', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}, {'title': 'Female children', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only CHILD sex is included in this analysis.'}, {'title': 'Parent education', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Less than high school education', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'High school education', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'Post-high school education', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only PARENT education levels are included in this analysis.'}, {'title': 'Marital status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Single', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}, {'title': 'Married or living together', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only PARENT marital status is included here.'}], 'populationDescription': 'Note the sample is comprised of N = 204 parent and child dyads or 408 total individuals. There are 84 parent-child dyads (168 total individuals) in the services-as-usual condition and 120 parent-child dyads (240 total individuals) in the PCIT intervention condition.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-02', 'size': 185447, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-08T13:46', 'hasProtocol': True}, {'date': '2020-09-02', 'size': 93563, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-08T13:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 408}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-12', 'studyFirstSubmitDate': '2016-02-02', 'resultsFirstSubmitDate': '2023-06-26', 'studyFirstSubmitQcDate': '2016-02-17', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-12', 'studyFirstPostDateStruct': {'date': '2016-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'BRIEF-A: Emotional Control Scale (Increased Parent Emotion Regulation)', 'timeFrame': 'pre- and post-intervention (8 months)', 'description': '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.'}, {'measure': "BRIEF (Behavioral Rating Inventory of Executive Function) Children's Outcomes", 'timeFrame': 'pre- and post-intervention', 'description': "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."}, {'measure': 'Parent Physiological Regulation', 'timeFrame': 'pre- and post-intervention', 'description': "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)."}, {'measure': 'Child Emotion Regulation', 'timeFrame': 'Post intervention (6 mo)', 'description': 'Emotional go/no-go task performance: False alarms to anger. Higher scores reflect greater rate of false alarms to anger (worse outcome).'}, {'measure': 'Child Physiological Regulation', 'timeFrame': 'pre- and post-intervention (8 months)', 'description': "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)."}, {'measure': 'Decreased Child Symptoms', 'timeFrame': 'pre- and post-intervention (8 months)', 'description': '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'}, {'measure': 'Eyberg Child Behavior Inventory (ECBI) Child Behavior Problem Scores (Decreased Disruptive Behavior Problems)', 'timeFrame': 'pre- and post-intervention (8 months)', 'description': '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.'}, {'measure': 'BRIEF-A: Parent Self-ratings', 'timeFrame': 'pre- and post-intervention (8 months)', 'description': 'Parents self-report on the BRIEF- A with lower scores reflecting fewer regulatory control problems. Standardized T-scores (M=50, SD = 10) are obtained.'}], 'primaryOutcomes': [{'measure': 'DPICS-IV Observed Parenting Skills (During Child-Led Play)', 'timeFrame': 'Pre- and Post-intervention (8 months)', 'description': '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.'}, {'measure': 'DPICS-IV Observational Coding During Clean Up Situation Task', 'timeFrame': 'Pre- and Post-intervention (8 months)', 'description': '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.'}, {'measure': 'Stop Signal Task: Increased Parent Inhibitory Control', 'timeFrame': 'pre- and post-intervention (8 months)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Reduced Child Maltreatment (CM) Recidivism', 'timeFrame': 'up to 1 year posttreatment', 'description': 'Fewer new episodes of CM per Maltreatment Classification Coding of Child Welfare case records'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Child Abuse', 'Parent Child Interaction Therapy (PCIT)', 'Evidenced Based Intervention', 'Self-control'], 'conditions': ['Child Abuse', 'Self-control', 'Parenting']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Aber JL, Cicchetti D. The social-emotional development of maltreated children: An empirical and theoretical analysis. In H. Fitzgerald, B. Lester, & M. Yogman (Eds.), Theory and research in behavioral pediatrics (Vol. 2, pp. 147-205). New York, NY: Plenum, 1984.'}, {'type': 'BACKGROUND', 'citation': 'Abidin RR. Parenting Stress Index (3rd ed.). 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Study Protocol: The Coaching Alternative Parenting Strategies (CAPS) Study of Parent-Child Interaction Therapy in Child Welfare Families. Front Psychiatry. 2020 Sep 2;11:839. doi: 10.3389/fpsyt.2020.00839. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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:\n\nAim 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).\n\nSpecific 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.\n\nSpecific 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resident of Lane County\n* Parent is 18 or older\n* Biological or custodial mother of a child between age 3 and 7 years at baseline\n* Resides in the same home setting with the child\n* Must be fluent in English\n* Mom and child must be physically able to complete the assessment\n* Family has an open case with Lane County Dept. Health Services.\n\nExclusion Criteria:\n\n* Child sexual abuse in the family'}, 'identificationModule': {'nctId': 'NCT02684903', 'acronym': 'CAPS', 'briefTitle': 'Coaching Alternative Parenting Strategies (CAPS) Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Oregon'}, 'officialTitle': 'Coaching Alternative Parenting Strategies (CAPS) Study: Targeting Neurobiological and Behavioral Mechanisms of Self-regulation in High-risk Families', 'orgStudyIdInfo': {'id': '1R01DA036533-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA036533-01A1', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Services As Usual (SAU)', 'description': "Participants receive all the usual services provided by Department of Human Services (DHS) Children's Services."}, {'type': 'EXPERIMENTAL', 'label': 'Parent Child Interaction Therapy (PCIT)', 'description': "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.\n\n.", 'interventionNames': ['Behavioral: Parent Child Interaction Therapy']}], 'interventions': [{'name': 'Parent Child Interaction Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['PCIT'], 'description': '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.', 'armGroupLabels': ['Parent Child Interaction Therapy (PCIT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97403', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'University of Oregon', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}], 'overallOfficials': [{'name': 'Elizabeth A Skowron, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oregon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oregon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Department of Psychology', 'investigatorFullName': 'Elizabeth Skowron', 'investigatorAffiliation': 'University of Oregon'}}}}