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Child Behavior ProblemPriCARENCT04110236

Pilot of Enhanced Child Adult Relationship Enhancement in Pediatric Primary Care

A study testing PriCARE and Positive Discipline Module in people with Child Behavior Problem and Parent-Child Relations, run by Children's Hospital of Philadelphia at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 several primary care clinics in Philadelphia and 2 primary care clinics in North Carolina. Read more about this study

Who is it for?
Ages 2 to 6 yearsHealthy volunteers can take part
What is being tested?
PriCARE and Positive Discipline Module
Could I receive a placebo?
No, everyone receives an active treatment
How many people
238 participants
Where
2 sitesUnited States
Study dates
3 Dec 2019to 4 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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
  • Caregiver must have the appropriate technological tools and access to participate when in-person sessions are not available
  • Child attends one of the CHOP primary care sites in Pennsylvania or one of two University of North Carolina (UNC Children's Primary Care and UNC Pediatrics at Panther Creek) primary care sites

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19146

Other trials in United States

About this study

Official title: Pilot Evaluation of Enhanced Child Adult Relationship Enhancement in Pediatric Primary Care (PriCARE) Intervention

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 several primary care clinics in Philadelphia and 2 primary care clinics in North Carolina.

Read the 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 several CHOP Primary Care Centers and two University of North Carolina primary care sites. The investigators intend to randomize up to 119 child-caregiver pairs (238 subjects) to receive PriCARE immediately plus usual treatment (intervention group) and up to 119 child-parent pairs (238 subjects) to receive PriCARE at a later time plus usual treatment (control group) for a total of up to 238 child-caregiver pairs (476 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).

Being tested
PriCARE, Positive Discipline Module
Keywords
Child behavior problems, Caregiver child relationship, Primary care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PriCAREBehavioural

    Also called Child Adult Relationship Enhancement in Primary Care

    PriCARE is a group caregiver training program designed to improve child behaviors, caregiver-child relationships, parenting capacity, and reduce caregiver stress. Sessions occur in the primary care clinic or virtually. PriCARE uses the 3 P skills (Praise, Paraphrase and Point-out-Behavior). The training starts with skills on giving attention to children's positive, pro-social behaviors, while ignoring minor misbehaviors. The second part of the training teaches skills for giving effective commands in order to set age-appropriate limits and increase compliance. 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.

  • Positive Discipline ModuleBehavioural

    Also called PriCARE Positive Discipline Module

    The PriCARE Positive Discipline Module is a pilot group caregiver training program designed to teach caregivers positive discipline techniques, including appropriate timeout procedures. The sessions are offered in the primary care setting or virtually. 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.

Study groups in NCT04110236
Study groupRoleWhat they receive
Immediate PriCAREExperimentalCaregiver-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 1-2 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.
Receives: Behavioral: PriCARE
Delayed PriCARENo interventionThe 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.
Immediate PriCARE Positive Discipline ModuleExperimentalA subset of participants (up to 40 caregiver-child pairs) 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. If they are randomized to the immediate PriCARE Positive Discipline group, they will attend an additional 4-6 sessions 4-6 weeks after completion of the 6-week PriCARE intervention. This module teaches 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.
Receives: Behavioral: Positive Discipline Module
Delayed PriCARE Positive Discipline ModuleNo interventionThe delayed Positive Discipline group will not receive the Positive Discipline Module intervention until after their third interview data collection is complete (in 2-3 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the Parenting Scale (PS) score from time 1 to 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

    Measured: Baseline (time 1), 8-17 weeks (time 2)

Secondary outcomes (4)

  1. Change in the Eyberg Child Behavior Inventory (ECBI) score from time 1 to 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.

    Measured: Baseline (time 1), 8-17 weeks (time 2)

  2. Change in the Dyadic Parent-Child Interaction Coding (DPICS) score from time 1 to 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.

    Measured: Baseline (time 1), 8-17 weeks (time 2)

  3. Change in the Child Abuse Potential Inventory (CAPI) score from time 1 to 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.

    Measured: Baseline (time 1), 8-17 weeks (time 2)

  4. Therapeutic Attitudes Inventory (TAI)

    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.

    Measured: 8-17 weeks (time 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2019
  2. Study start3 Dec 2019
  3. Primary completion22 Jun 2022
  4. Study completion4 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
238 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04110236
Sponsor's protocol ID
19-016283
Acronym
PriCARE
Status last verified
Mar 2023
First submitted
27 Sep 2019
Last updated
20 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Weitzman C, Wegner L; Section on Developmental and Behavioral Pediatrics; Committee on Psychosocial Aspects of Child and Family Health; Council on Early Childhood; Society for Developmental and Behavioral Pediatrics; American Academy of Pediatrics. Promoting optimal development: screening for behavioral and emotional problems. Pediatrics. 2015 Feb;135(2):384-95. doi: 10.1542/peds.2014-3716.

    PubMed 25624375

  • Bultas MW, McMillin SE, Broom MA, Zand DH. Brief, Rapid Response, Parenting Interventions Within Primary Care Settings. J Behav Health Serv Res. 2017 Oct;44(4):695-699. doi: 10.1007/s11414-015-9479-2.

    PubMed 26289564

  • Querido JG, Warner TD, Eyberg SM. Parenting styles and child behavior in African American families of preschool children. J Clin Child Adolesc Psychol. 2002 Jun;31(2):272-7. doi: 10.1207/S15374424JCCP3102_12.

    PubMed 12056110

  • Asarnow JR, Rozenman M, Wiblin J, Zeltzer L. Integrated Medical-Behavioral Care Compared With Usual Primary Care for Child and Adolescent Behavioral Health: A Meta-analysis. JAMA Pediatr. 2015 Oct;169(10):929-37. doi: 10.1001/jamapediatrics.2015.1141.

    PubMed 26259143

  • Meadows T, Valleley R, Haack MK, Thorson R, Evans J. Physician "costs" in providing behavioral health in primary care. Clin Pediatr (Phila). 2011 May;50(5):447-55. doi: 10.1177/0009922810390676. Epub 2010 Dec 30.

    PubMed 21196418

  • 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.

  • Schuhmann EM, Foote RC, Eyberg SM, Boggs SR, Algina J. Efficacy of parent-child interaction therapy: interim report of a randomized trial with short-term maintenance. J Clin Child Psychol. 1998 Mar;27(1):34-45. doi: 10.1207/s15374424jccp2701_4.

    PubMed 9561935

  • Eyberg SM, Ross AW. Assessment of Child Behavior Problems: The Validation of a New Inventory. J Clin Child Psycho. 1978.

  • McKelvey LM, Burrow NA, Balamurugan A, Whiteside-Mansell L, Plummer P. Effects of home visiting on adolescent mothers' parenting attitudes. Am J Public Health. 2012 Oct;102(10):1860-2. doi: 10.2105/AJPH.2012.300934. Epub 2012 Aug 16.

    PubMed 22897545

  • 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.

  • Irvine AB, Biglan A, Smolkowski K, Ary DV. The value of the Parenting Scale for measuring the discipline practices of parents of middle school children. Behav Res Ther. 1999 Feb;37(2):127-42. doi: 10.1016/s0005-7967(98)00114-4.

    PubMed 9990744

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing PriCARE and Positive Discipline Module in people with Child Behavior Problem and Parent-Child Relations, run by Children's Hospital of Philadelphia at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Parenting Scale (PS) score from time 1 to time 2 (time frame: Baseline (time 1), 8-17 weeks (time 2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04110236, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.

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