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Pilot of Enhanced Child Adult Relationship Enhancement in Pediatric Primary Care (PriCARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110236
Recruitment Status : Not yet recruiting
First Posted : October 1, 2019
Last Update Posted : November 8, 2019
Sponsor:
Collaborators:
Annie E. Casey Foundation
The Pew Charitable Trusts
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:
The purpose of this study is to evaluate the efficacy of the enhanced PriCARE intervention in improving parenting capacity, decreasing child behavior problems, and reducing risk of child maltreatment at 4 primary care clinics in Philadelphia and 2 primary care clinics in North Carolina.

Condition or disease Intervention/treatment Phase
Child Behavior Problem Parent-Child Relations Behavioral: PriCARE Behavioral: Positive Discipline Module Not Applicable

Detailed Description:

Child behavioral concerns are common among families served by Children's Hospital of Philadelphia (CHOP) and University of North Carolina (UNC) pediatric primary care centers. To address this, Child Adult Relationship Enhancement in Pediatric Primary Care (PriCARE) was developed. PriCARE has been evaluated in primary care centers at CHOP and UNC with promising findings with regards to reductions in child behavioral problems. The PriCARE curriculum has now been enhanced with strategies to increase participant engagement, retention of skills, and attendance. Efficacy of this enhanced PriCARE curriculum has not yet been evaluated. Nor has the impact of the PriCARE intervention on child maltreatment risk been explored.

The primary objective of this study is to evaluate the efficacy of the enhanced PriCARE program to improve parenting capacity as measured by the Parenting Scale total score and 3 sub-scales.

The secondary objectives are to:

  1. Measure the impact of PriCARE on parent-reported child behavior problems as assessed by the Eyberg Child Behavior Inventory intensity and problems scales.
  2. Measure the impact of PriCARE on the quality of the parent-child relationship as measured by the Dyadic Parent-Child Interaction Coding.
  3. Measure the impact of PriCARE on the risk of child maltreatment as measured by the Child Abuse Potential Inventory.
  4. Identify and describe predictors of attendance in PriCARE groups.
  5. Identify and describe modifiers of the efficacy of PriCARE including but not limited to caregiver and child demographics.
  6. Assess caregivers' perceptions of the efficacy of PriCARE on improving parenting skills and child behavior as measured by the Therapeutic Attitude Inventory (TAI).
  7. Develop and pilot a new PriCARE Positive Discipline Module.
  8. Collect pilot data on added benefit of completing the PriCARE Positive Discipline Module.

The investigators will perform a randomized controlled trial (RCT) of the effectiveness of the enhanced PriCARE on objectives listed above among 2- to 6-year-old children and their parents at four CHOP urban Primary Care Centers and two University of North Carolina primary care sites. The investigators intend to randomize up to 110 child-caregiver pairs (220 subjects) to receive PriCARE immediately plus usual treatment (intervention group) and up to 110 child-parent pairs (220 subjects) to receive PriCARE at a later time plus usual treatment (control group) for a total of up to 220 child-caregiver pairs (440 subjects). All child-caregivers pairs randomized to the control group will be placed on a waitlist and offered PriCARE after completion of data collection. Child maltreatment risk, parenting attitudes and skills, child behavior, and quality of the child-caregiver relationship will be measured at baseline (time 1) and approximately 8-17 weeks after randomization (time 2) for both the intervention and control groups. The follow up interview will also include a brief satisfaction questionnaire for participants randomized to the intervention group. For the subgroup of participants who complete the Positive Discipline Module, these measurements will be repeated approximately 2-4 weeks after completion of the Positive Discipline intervention (time 3).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The study team member who will administer the follow-up study interviews will remain blinded to the group status throughout the duration of the study.
Primary Purpose: Treatment
Official Title: Pilot Evaluation of Enhanced Child Adult Relationship Enhancement in Pediatric Primary Care (PriCARE) Intervention
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arm Intervention/treatment
Experimental: Immediate PriCARE
Caregiver-child dyads assigned to the immediate PriCARE group will receive the PriCARE intervention as soon as possible plus usual treatment. The intervention will last approximately 6-8 weeks. Each group will have approximately 4-13 participants and 2 facilitators and will meet 6 times for 1-2 hours per session. Parents are expected to practice the skills they learn with their children between sessions.
Behavioral: PriCARE
PriCARE is a group caregiver training program located in the primary care setting designed to improve child behaviors, caregiver-child relationships, parenting capacity, and reduce caregiver stress. PriCARE uses the 3 P skills (Praise, Paraphrase and Point-out-Behavior). The training starts with skills focused on giving attention to children's positive, pro-social behaviors, while ignoring minor misbehaviors. The second part of the training teaches techniques for giving effective commands in order to set age-appropriate limits and increase compliance to commands. PriCARE includes a stress education section that contextualizes the use of these skills with the types of behaviors and problems exhibited by many children living with psychosocial adversity and familial stress. Caregivers are encouraged to practice the skills with their child in between sessions. Since PriCARE's initial and successful pilot, the intervention has been enhanced in order to increase engagement and effectiveness.
Other Name: Child Adult Relationship Enhancement in Primary Care

No Intervention: Delayed PriCARE
The delayed PriCARE group will not receive the PriCARE intervention until after their data collection for this study is complete (in 3-6 months). In addition, they will be immediately offered usual treatment. Under usual treatment, patients will be referred to a behavioral health specialist at the discretion of their pediatrician and the office social worker for additional diagnosis and treatment.
Experimental: Positive Discipline PriCARE
A subset of participants who were assigned to the immediate PriCARE group will be offered to participate in the PriCARE Positive Discipline Module if they attended at least 4 PriCARE sessions and completed both main study interviews. This module will occur 4-6 weeks after completion of the 6-week PriCARE intervention and will teach techniques related to behavior reward charts, appropriate timeout protocol, and other positive discipline techniques for handling persistent behaviors not addressed by the other PriCARE skills.
Behavioral: PriCARE
PriCARE is a group caregiver training program located in the primary care setting designed to improve child behaviors, caregiver-child relationships, parenting capacity, and reduce caregiver stress. PriCARE uses the 3 P skills (Praise, Paraphrase and Point-out-Behavior). The training starts with skills focused on giving attention to children's positive, pro-social behaviors, while ignoring minor misbehaviors. The second part of the training teaches techniques for giving effective commands in order to set age-appropriate limits and increase compliance to commands. PriCARE includes a stress education section that contextualizes the use of these skills with the types of behaviors and problems exhibited by many children living with psychosocial adversity and familial stress. Caregivers are encouraged to practice the skills with their child in between sessions. Since PriCARE's initial and successful pilot, the intervention has been enhanced in order to increase engagement and effectiveness.
Other Name: Child Adult Relationship Enhancement in Primary Care

Behavioral: Positive Discipline Module
The PriCARE Positive Discipline Module is a pilot group caregiver training program located in the primary care setting designed to teach caregivers positive discipline techniques, including appropriate timeout procedures. This training will supplement the content of the main PriCARE intervention and provide caregivers with skills for addressing difficult behaviors not reduced through positive attention and strategic ignoring. This module will be offered to a subset of CHOP participants who were randomized to the intervention arm, successfully completed the main study interviews, and attended at least 4 out of the 6 PriCARE sessions.
Other Name: PriCARE Positive Discipline Module




Primary Outcome Measures :
  1. Change in the Parenting Scale (PS) score from time 1 to time 2 [ Time Frame: Baseline (time 1), 8-17 weeks (time 2) ]
    The primary objective of the study is to evaluate the efficacy of the enhanced PriCARE program to improve parenting capacity as measured by the Parenting Scale (PS), a 30-item questionnaire that assesses dysfunctional parenting discipline strategies. Participants respond to various hypothetical situations with a 7-point Likert scale, where 7 is the "ineffective" end of the scale and a lower overall score indicates more effective parenting. There are 3 scale factors: 1) laxness, 2) over-reactivity, and 3) verbosity. Some items are unrelated to any of these 3 factors. The 11 Laxness items relate to permissive discipline, lack of rule reinforcement and providing positive consequences for misbehaviors. The 10 Over-Reactivity items reflect anger, irritability or meanness. The 7 Verbosity items suggest longer verbal responses such as talking when talking is ineffective. All item responses are averaged to compute the total score. Each factors' items are averaged to compute the factor scores


Secondary Outcome Measures :
  1. Change in the Eyberg Child Behavior Inventory (ECBI) score from time 1 to time 2 [ Time Frame: Baseline (time 1), 8-17 weeks (time 2) ]
    The investigators will assess the efficacy of the enhanced PriCARE on decreasing caregiver-reported child behavior problems as measured by the ECBI. The ECBI is a parent rating scale designed to measure conduct problem behaviors in children ages 2-16 years old. The instrument contains 36 items that assess behavior on two scales. The problem scale provides a yes/no problem identification rating for each item, and the sum of yes responses yields a problem score with a potential range from 0 to 36 with a clinical cutoff of 15. The intensity scale provides a frequency-of-occurrence rating for each item, ranging from never (1) to always (7) and the ratings are summed to yield an intensity score with a potential range from 36 to 252 with a clinical cutoff of 131. Higher scores indicate worse outcomes.

  2. Change in the Dyadic Parent-Child Interaction Coding (DPICS) score from time 1 to time 2 [ Time Frame: Baseline (time 1), 8-17 weeks (time 2) ]
    Investigators will assess the efficacy of enhanced PriCARE on impacting the quality of the caregiver-child relationship with the DPICS. Each dyad is observed in 3 standard situations that involve varying levels of parental control and display dyadic interactions targeted by PriCARE: child-led play, caregiver-led play, clean-up. The coding manual has definitions, examples, and guidelines for deciding how to code the 24 standard caregiver and child behaviors. The interactions are video-recorded and coded by a blinded research assistant. Zero, or not observed, is the minimum for all behaviors. The total score is the sum of the coded behaviors within each category, thus there is no set maximum. A second research assistant re-codes 25% of randomly selected videos to check for coding reliability. Reliability will be assessed using % agreement, intraclass correlations, and Cohen's kappa. Comparing pre- and post-intervention videos will demonstrate caregiver and child behavior changes.

  3. Change in the Child Abuse Potential Inventory (CAPI) score from time 1 to time 2 [ Time Frame: Baseline (time 1), 8-17 weeks (time 2) ]
    CAPI change scores from time 1 to time 2 will be measured. CAPI, a 160-item survey, measures traits & parenting styles typical of known physical child abusers. Each item has a weighted value based on if agree vs. disagree is chosen and then the values are summed. Child physical abuse scores range from 0-486 with higher scores indicating caregiver has traits similar to those of known child abusers and has a higher risk of abuse. Ranges for factor scales are: distress (0-261), rigidity (0-64), unhappiness (0-69), problems with child and self (0-30), problems with family (0-38), problems with others (0-24) Higher factor scores imply higher symptom levels. Three validity scales and ranges are: lie (0-18), random (0-18), inconsistency (0-20). Ego-strength score ranges from 0-40 with higher score indicating more emotional stability. Loneliness score ranges from 0-15; higher score means more isolation.

  4. Therapeutic Attitudes Inventory (TAI) [ Time Frame: 8-17 weeks (time 2) ]
    The investigators will assess caregivers' perceptions of the efficacy of PriCARE on improving parenting skills and child behavior as measured by the TAI. The TAI is a brief 10-question satisfaction measure of parent training and parent-child treatments. Questions are answered on a 5-point Likert scale with 1 indicating the lowest ("nothing", "much worse than before", "much less confident", etc.) and 5 indicating the highest ("very many useful techniques", "very much better than before", "more confident", etc.). Responses are added together and greater TAI total scores indicate greater levels of participant satisfaction. The potential scores range from 10-50.


Other Outcome Measures:
  1. Change in the Parenting Scale (PS) score from time 2 to time 3 [ Time Frame: 8-17 weeks (time 2) to 14-24 weeks (time 3) ]
    Change in PS from time 2 to time 3 will be measured in the subset of CHOP participants completing the Positive Discipline Module. PS is a 30-item questionnaire that assesses dysfunctional parenting discipline strategies. Participants respond to various hypothetical situations with a 7-point Likert scale, where 7 is the "ineffective" end of the scale and a lower overall score indicates more effective parenting. There are 3 scale factors: 1) laxness, 2) over-reactivity, and 3) verbosity. Some items are unrelated to any of these 3 factors. The 11 Laxness items relate to permissive discipline, lack of rule reinforcement and providing positive consequences for misbehaviors. The 10 Over-Reactivity items reflect anger, irritability or meanness. The 7 Verbosity items suggest longer verbal responses such as talking when talking is ineffective. All item responses are averaged to compute the total score. Each factors' items are averaged to compute the factor scores.

  2. Change in the Eyberg Child Behavior Inventory (ECBI) score from time 2 to time 3 [ Time Frame: 8-17 weeks (time 2), 14-24 weeks (time 3) ]
    Change in ECBI scores from time 2 to time 3 will be measured in the subset of CHOP participants completing the Positive Discipline Module. The ECBI is a parent rating scale designed to measure conduct problem behaviors in children ages 2-16 years old. The instrument contains 36 items that assess behavior on two scales. The problem scale provides a yes/no problem identification rating for each item, and the sum of yes responses yields a problem score with a potential range from 0 to 36 with a clinical cutoff of 15. The intensity scale provides a frequency-of-occurrence rating for each item, ranging from never (1) to always (7) and the ratings are summed to yield an intensity score with a potential range from 36 to 252 with a clinical cutoff of 131. Higher scores indicate worse outcomes.

  3. Change in the Dyadic Parent-Child Interaction Coding (DPICS) score from time 2 to time 3 [ Time Frame: 8-17 weeks (time 2), 14-24 weeks (time 3) ]
    Change in DPICS scores from time 2 to time 3 will be measured in the subset of CHOP participants completing the Positive Discipline Module. Each dyad is observed in 3 standard situations that involve varying levels of parental control and display dyadic interactions targeted by PriCARE: child-led play, caregiver-led play, clean-up. The coding manual has definitions, examples, and guidelines for deciding how to code the 24 standard caregiver and child behaviors. The interactions are video-recorded and coded by a blinded research assistant. Zero, or not observed, is the minimum for all behaviors. The total score is the sum of the coded behaviors within each category, thus there is no set maximum. A second research assistant re-codes 25% of randomly selected videos to check for coding reliability. Reliability will be assessed using % agreement, intraclass correlations, and Cohen's kappa. Comparing pre- and post-intervention videos will demonstrate caregiver and child behavior changes.

  4. Therapeutic Attitudes Inventory (TAI) at time 3 [ Time Frame: 14-24 weeks (time 3) ]
    The investigators will assess caregivers' perceptions of the efficacy of PriCARE on improving parenting skills and child behavior as measured by the TAI at time 3 for the subset of participants completing the Positive Discipline Module. The TAI is a brief 10-question satisfaction measure of parent training and parent-child treatments. Questions are answered on a 5-point Likert scale with 1 indicating the lowest ("nothing", "much worse than before", "much less confident", etc.) and 5 indicating the highest ("very many useful techniques", "very much better than before", "more confident", etc.). Responses are added together and greater TAI total scores indicate greater levels of participant satisfaction. The potential scores range from 10-50.

  5. Change in the Child Abuse Potential Inventory (CAPI) score from baseline to time 2 to time 3 [ Time Frame: 8-17 weeks (time 2), 14-24 weeks (time 3) ]
    CAPI change scores from time 2 to 3 will be measured in subjects participating in the Positive Discipline Module. CAPI, a 160-item survey, measures traits & parenting styles typical of known physical child abusers. Each item has a weighted value based on if agree vs. disagree is chosen and then the values are summed. Child physical abuse scores range from 0-486 with higher scores indicating the caregiver has traits similar to those of known child abusers and has a higher risk of abuse. Ranges for factor scales are: distress (0-261), rigidity (0-64), unhappiness (0-69), problems with child and self (0-30), problems with family (0-38), problems with others (0-24) Higher factor scores imply higher symptom levels. Three validity scales and ranges are: lie (0-18), random (0-18), inconsistency (0-20). Ego-strength score ranges from 0-40 with higher score indicating more emotional stability. Loneliness score ranges from 0-15; higher score means more isolation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Caregiver is 18 years or older
  • Caregiver is English speaking
  • Caregiver is legal guardian of child and provides informed consent
  • Caregiver has cellular phone with text messaging capacity
  • Caregiver is available for scheduled times PriCARE hosts groups
  • Child is 2-6 years old
  • Child attends one of four CHOP primary care sites (CHOP's South Philadelphia Primary Care Center, Karabots Pediatric Care Center, Cobbs Creek Pediatric Care Center, Primary Care, and CHOP Campus) or one of two University of North Carolina (UNC Children's Primary Care and UNC Pediatrics at Panther Creek) primary care sites

Exclusion Criteria:

  • Caregiver has already completed the PriCARE program
  • Child has already received a behavioral health diagnosis or is already receiving individualized behavior health therapy or associated medication for Oppositional Defiance Disorder, Conduct Disorder, or Attention- Deficit/Hyperactivity Disorder
  • Child is being evaluated for or has been diagnosed with autism
  • Child has a cognitive age less than 2 years old as determined by screening questions and/or the referring clinician.
  • Child has caused physical injuries, such as bruises or cuts, more than once and on purpose to their caregiver, him/herself, or other children or people

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110236


Contacts
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Contact: Joanne Wood, MD, MSHP 267-426-3107 woodjo@email.chop.edu
Contact: Devon Kratchman, BS 267-425-1735 kratchmand@email.chop.edu

Locations
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United States, North Carolina
University of North Carolina Not yet recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Samantha Schilling, MS, MSHP    919-966-2504    samantha_schilling@med.unc.edu   
Sub-Investigator: Samantha Schilling, MD, MSHP         
United States, Pennsylvania
Children's Hospital of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States, 19146
Contact: Joanne Wood, MD, MSHP    267-426-3107    woodjo@email.chop.edu   
Contact: Devon Kratchman, BS    267-425-1735    kratchmand@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
Annie E. Casey Foundation
The Pew Charitable Trusts
Investigators
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Principal Investigator: Joanne Wood, MD, MSHP Children's Hospital of Philadelphia

Publications:
Ward-Zimmerman B, Cannata E. Partnering with pediatric primary care: Lessons learned through collaborative colocation. Professional Psychology: Research and Practice. 2012;43(6):596-605.
Eyberg SM, Ross AW. Assessment of Child Behavior Problems: The Validation of a New Inventory. J Clin Child Psycho. 1978.
Arnold DS, O'Leary SG, Wolff LS, Acker MM. The Parenting Scale: A measure of dysfunctional parenting in discipline situations. Psychological Assessment. 1993;5(2):137-44. doi: 10.1037/1040-3590.5.2.137.
Karazsia B, Dulmen M, Wildman B. Confirmatory Factor Analysis of Arnold et al.'s Parenting Scale Across Race, Age, and Sex. Journal of Child & Family Studies. 2008;17(4):500-16. doi: 10.1007/s10826-007-9170-1. PubMed PMID: 32587293.
Steele RG, Nesbitt-Daly JS, Daniel RC, Forehand R. Factor Structure of the Parenting Scale in a Low-Income African American Sample. Journal of Child & Family Studies. 2005;14(4):535-49. doi: 10.1007/s10826-005-7187-x. PubMed PMID: 18485834.
Burns G, Patterson D. Conduct problem behaviors in a stratified random sample of children and adolescents: New Standardization data on the Eyberg Child Behavior Inventory. Psychological Assessment. 1990;2:291-297.
Colvin A, Eyberg S, Adams C. Restandardization of the Eyberg Child Behavior Inventory. 1999
Robinson E, Eyberg S, Ross W. The standardization of an inventory of child conduct problem behaviors. Journal of Clinical Child Psychology. 1980;9:22-28.
Funderburk B, Eyberg SM, Rich BA, Behar L. Further Psychometric Evaluation of the Eyberg and Behar Rating Scales for Parents and Teachers of Preschoolers. Early Education and Development. 2003;14(1):67-81.
Achenbach T. Integrative Guide to the 1991 CBCL/4-18, YSR, and TRF Profiles. Burlington, VT: University of Vermontm 1991.
Eyberg S, Pincus D. Eyberg Child Behavior Inventory and Stutter-Eyberg Student Behavior Inventory-revised: Professional manual. Odessa, FL1999.
Brestan EV JJ, Rayfield AD, Eybert SM. A consumer satisfaction measure for parent-child treatments and its relation to measures of child behavior change. Behavior Therapy. 1999;30:17-30.
Eyberg S, Bessmer J, Newcomb K, Edwards D, Robinson E. Dyadic Parent-Child Interaction Coding Scheme II: A manual. Unpublished manuscript, University of Florida. 1994.
Eyberg SM, Nelson MM, Duke M, Boggs SR. Manual for the Dyadic Parent-Child Interaction Coding System Third Edition. 2004.
Bessmer JL. The Dyadic Parent-Child Interaction Coding System II (DPICS II): Reliability and validity, ProQuest Information & Learning; 1998.
Foote RC. The Dyadic Parent-Child Interaction Coding System II (DPICS II): Reliability and validity with father-child dyads, ProQuest Information & Learning; 2000.
Milner J. The Child Abuse Potential Inventory: Manual. 2nd ed ed. Webster, NC: Psytec; 1986.
Milner J. An interpretive manual for the Child Abuse Potential Inventory. DeKalb, IL: Psytec; 2006.
Milner JS. Assessing physical child abuse risk: The Child Abuse Potential Inventory. Clinical Psychology Review. 1994;14:547-583.

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT04110236     History of Changes
Other Study ID Numbers: 19-016283
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
Child behavior problems
Caregiver child relationship
Primary care
Additional relevant MeSH terms:
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Problem Behavior
Behavioral Symptoms