Pilot of Enhanced Child Adult Relationship Enhancement in Pediatric Primary Care
NCT ID: NCT04110236
Last Updated: 2023-03-20
Study Results
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Basic Information
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COMPLETED
NA
238 participants
INTERVENTIONAL
2019-12-03
2022-08-04
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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 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.
PriCARE
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.
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.
No interventions assigned to this group
Immediate PriCARE Positive Discipline Module
A 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.
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.
Delayed PriCARE Positive Discipline Module
The 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.
No interventions assigned to this group
Interventions
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PriCARE
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 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
2 Years
6 Years
ALL
Yes
Sponsors
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Annie E. Casey Foundation
OTHER_GOV
The Pew Charitable Trusts
OTHER
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Joanne Wood, MD, MSHP
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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University of North Carolina
Chapel Hill, North Carolina, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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Kiely J, DePaul E, Rojas S, Cortes S, Schilling S, Dougherty S, Wood JN. Evaluation of Virtual Enhanced Child Adult Relationship Enhancement in Primary Care Intervention. J Dev Behav Pediatr. 2024 Sep-Oct 01;45(5):e439-e447. doi: 10.1097/DBP.0000000000001292. Epub 2024 Jun 21.
Other Identifiers
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19-016283
Identifier Type: -
Identifier Source: org_study_id
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