Trial Outcomes & Findings for Parent Program to Improve Child Behavior Problems (NCT NCT02049749)
NCT ID: NCT02049749
Last Updated: 2019-04-12
Results Overview
Behavior will be measured by the Eyberg Child Behavior Inventory (ECBI). The primary outcome is the ECBI change score (time 3-time1). The ECBI is a parent rating scale designed to measure conduct problem behaviors in children ages 2-16 years. 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. The ECBI has demonstrated strong internal consistency, test-retest reliability, and discriminant validity and has been shown to be a sensitive indicator of intervention efficacy for child behavior problems.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
240 participants
Primary outcome timeframe
Mean Change in ECBI Scores from Baseline to 14-18 weeks. Decreases in ECBI scores reflect improvements in behavior.
Results posted on
2019-04-12
Participant Flow
Participant milestones
| Measure |
No Intervention: Delayed CARE
40 child-caregiver pairs will be randomized to usual treatment plus delayed PriCARE (control). 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 and/or provided with a 1-2 page informational handout on child behavior problems from the CHOP patient care manual. Following the final interview (3-4 months after enrollment for each subject) all participants randomized to the control arm (usual treatment plus delayed PriCARE) will receive the PriCARE training, if desired.
|
Experimental: Immediate CARE
80 child-caregiver pairs will be randomized to usual treatment plus immediate PriCARE, a 6 session adaptation of the CARE group parent training. CARE was developed by Trauma Treatment Training Center and informed by the principles of Parent Child Interaction Therapy. CARE has been used in many populations including daycare providers, biological parents, and foster parents. Goals are to decrease caregiver stress, improve child behavior, and enhance the caregiver-child relationship, family stability, and wellness. CARE teaches parents to follow a child's lead thus building a connection and promoting positive behaviors. CARE focuses on giving attention to child's pro-social behavior and ignoring minor misbehavior. CARE teaches techniques for giving effective commands. The PriCARE curriculum involves 6 1-2 hour sessions over 6-8 weeks. 2 mental health providers lead PriCARE trainings for groups of 4-10 caregivers. Children do not attend PriCARE.
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
160
|
|
Overall Study
COMPLETED
|
80
|
160
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Caregiver relationship is provided for caregiver participants only
Baseline characteristics by cohort
| Measure |
No Intervention: Delayed CARE
n=80 Participants
40 child-caregiver pairs will be randomized to usual treatment plus delayed PriCARE (control). 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 and/or provided with a 1-2 page informational handout on child behavior problems from the CHOP patient care manual. Following the final interview (3-4 months after enrollment for each subject) all participants randomized to the control arm (usual treatment plus delayed PriCARE) will receive the PriCARE training, if desired
|
Experiemental: Immediate CARE
n=160 Participants
80 child-caregiver pairs will be randomized to usual treatment plus immediate PriCARE, a 6 session adaptation of the CARE group parent training. CARE was developed by Trauma Treatment Training Center and informed by the principles of Parent Child Interaction Therapy. CARE has been used in many populations including daycare providers, biological parents, and foster parents. Goals are to decrease caregiver stress, improve child behavior, and enhance the caregiver-child relationship, family stability, and wellness. CARE teaches parents to follow a child's lead thus building a connection and promoting positive behaviors. CARE focuses on giving attention to child's pro-social behavior and ignoring minor misbehavior. CARE teaches techniques for giving effective commands. The PriCARE curriculum involves 6 1-2 hour sessions over 6-8 weeks. 2 mental health providers lead PriCARE trainings for groups of 4-10 caregivers. Children do not attend PriCARE.
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
40 Participants
n=80 Participants
|
80 Participants
n=160 Participants
|
120 Participants
n=240 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=80 Participants
|
80 Participants
n=160 Participants
|
120 Participants
n=240 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=80 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=240 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=80 Participants
|
105 Participants
n=160 Participants
|
163 Participants
n=240 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=80 Participants
|
55 Participants
n=160 Participants
|
77 Participants
n=240 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=80 Participants
|
22 Participants
n=160 Participants
|
33 Participants
n=240 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=80 Participants
|
138 Participants
n=160 Participants
|
206 Participants
n=240 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=80 Participants
|
0 Participants
n=160 Participants
|
1 Participants
n=240 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=80 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=240 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=80 Participants
|
4 Participants
n=160 Participants
|
4 Participants
n=240 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=80 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=240 Participants
|
|
Race (NIH/OMB)
Black or African American
|
54 Participants
n=80 Participants
|
103 Participants
n=160 Participants
|
157 Participants
n=240 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=80 Participants
|
46 Participants
n=160 Participants
|
68 Participants
n=240 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=80 Participants
|
2 Participants
n=160 Participants
|
6 Participants
n=240 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=80 Participants
|
5 Participants
n=160 Participants
|
5 Participants
n=240 Participants
|
|
Caregiver relationship to child
Mother
|
40 Participants
n=40 Participants • Caregiver relationship is provided for caregiver participants only
|
74 Participants
n=80 Participants • Caregiver relationship is provided for caregiver participants only
|
114 Participants
n=120 Participants • Caregiver relationship is provided for caregiver participants only
|
|
Caregiver relationship to child
Father
|
0 Participants
n=40 Participants • Caregiver relationship is provided for caregiver participants only
|
1 Participants
n=80 Participants • Caregiver relationship is provided for caregiver participants only
|
1 Participants
n=120 Participants • Caregiver relationship is provided for caregiver participants only
|
|
Caregiver relationship to child
Grandmother
|
0 Participants
n=40 Participants • Caregiver relationship is provided for caregiver participants only
|
5 Participants
n=80 Participants • Caregiver relationship is provided for caregiver participants only
|
5 Participants
n=120 Participants • Caregiver relationship is provided for caregiver participants only
|
|
ECBI Problem Scale
|
18 units on a scale
STANDARD_DEVIATION 8 • n=40 Participants • ECBI measures were only collected on child participants and not caregivers
|
21 units on a scale
STANDARD_DEVIATION 8 • n=80 Participants • ECBI measures were only collected on child participants and not caregivers
|
20 units on a scale
STANDARD_DEVIATION 8 • n=120 Participants • ECBI measures were only collected on child participants and not caregivers
|
|
ECBI Intensity Scale
|
139 units on a scale
STANDARD_DEVIATION 39 • n=40 Participants • ECBI Measures only collected for child participants.
|
153 units on a scale
STANDARD_DEVIATION 39 • n=80 Participants • ECBI Measures only collected for child participants.
|
149 units on a scale
STANDARD_DEVIATION 40 • n=120 Participants • ECBI Measures only collected for child participants.
|
|
Adult Adolescent Parenting Inventory 2 (AAPI2)
Expectations
|
4.45 units on a scale
STANDARD_DEVIATION 1.53 • n=40 Participants • AAPI scores were only measured and reported for caregiver participants
|
4.66 units on a scale
STANDARD_DEVIATION 1.66 • n=80 Participants • AAPI scores were only measured and reported for caregiver participants
|
4.59 units on a scale
STANDARD_DEVIATION 1.62 • n=120 Participants • AAPI scores were only measured and reported for caregiver participants
|
|
Adult Adolescent Parenting Inventory 2 (AAPI2)
Empathy
|
4.23 units on a scale
STANDARD_DEVIATION 2.14 • n=40 Participants • AAPI scores were only measured and reported for caregiver participants
|
4.21 units on a scale
STANDARD_DEVIATION 2.06 • n=80 Participants • AAPI scores were only measured and reported for caregiver participants
|
4.22 units on a scale
STANDARD_DEVIATION 2.08 • n=120 Participants • AAPI scores were only measured and reported for caregiver participants
|
|
Adult Adolescent Parenting Inventory 2 (AAPI2)
Corporal Punishment
|
5.40 units on a scale
STANDARD_DEVIATION 1.37 • n=40 Participants • AAPI scores were only measured and reported for caregiver participants
|
5.67 units on a scale
STANDARD_DEVIATION 1.78 • n=80 Participants • AAPI scores were only measured and reported for caregiver participants
|
5.58 units on a scale
STANDARD_DEVIATION 1.66 • n=120 Participants • AAPI scores were only measured and reported for caregiver participants
|
|
Adult Adolescent Parenting Inventory 2 (AAPI2)
Parent-child roles
|
5.30 units on a scale
STANDARD_DEVIATION 2.14 • n=40 Participants • AAPI scores were only measured and reported for caregiver participants
|
5.16 units on a scale
STANDARD_DEVIATION 2.32 • n=80 Participants • AAPI scores were only measured and reported for caregiver participants
|
5.21 units on a scale
STANDARD_DEVIATION 2.26 • n=120 Participants • AAPI scores were only measured and reported for caregiver participants
|
|
Adult Adolescent Parenting Inventory 2 (AAPI2)
Power and independence
|
5.22 units on a scale
STANDARD_DEVIATION 2.12 • n=40 Participants • AAPI scores were only measured and reported for caregiver participants
|
5.20 units on a scale
STANDARD_DEVIATION 1.93 • n=80 Participants • AAPI scores were only measured and reported for caregiver participants
|
5.21 units on a scale
STANDARD_DEVIATION 1.99 • n=120 Participants • AAPI scores were only measured and reported for caregiver participants
|
PRIMARY outcome
Timeframe: Mean Change in ECBI Scores from Baseline to 14-18 weeks. Decreases in ECBI scores reflect improvements in behavior.Population: Eyberg Child Behavior Inventory (ECBI) is a 36 item parent rating scale that measures problem behaviors in children 2-16 on the problem scale and intensity scale.The intensity score (range 36-252) is the total frequency of occurrence for the behaviors. The problem score (range 0-36) is the total number of behaviors for which the response is "yes".
Behavior will be measured by the Eyberg Child Behavior Inventory (ECBI). The primary outcome is the ECBI change score (time 3-time1). The ECBI is a parent rating scale designed to measure conduct problem behaviors in children ages 2-16 years. 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. The ECBI has demonstrated strong internal consistency, test-retest reliability, and discriminant validity and has been shown to be a sensitive indicator of intervention efficacy for child behavior problems.
Outcome measures
| Measure |
No Intervention: Delayed CARE
n=40 Participants
40 child-caregiver pairs will be randomized to usual treatment plus delayed PriCARE (control). 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 and/or provided with a 1-2 page informational handout on child behavior problems from the CHOP patient care manual. Following the final interview (3-4 months after enrollment for each subject) all participants randomized to the control arm (usual treatment plus delayed PriCARE) will receive the PriCARE training, if desired
|
Experiemental: Immediate CARE
n=80 Participants
80 child-caregiver pairs will be randomized to usual treatment plus immediate PriCARE, a 6 session adaptation of the CARE group parent training. CARE was developed by Trauma Treatment Training Center and informed by the principles of Parent Child Interaction Therapy. CARE has been used in many populations including daycare providers, biological parents, and foster parents. Goals are to decrease caregiver stress, improve child behavior, and enhance the caregiver-child relationship, family stability, and wellness. CARE teaches parents to follow a child's lead thus building a connection and promoting positive behaviors. CARE focuses on giving attention to child's pro-social behavior and ignoring minor misbehavior. CARE teaches techniques for giving effective commands. The PriCARE curriculum involves 6 1-2 hour sessions over 6-8 weeks. 2 mental health providers lead PriCARE trainings for groups of 4-10 caregivers. Children do not attend PriCARE.
|
|---|---|---|
|
Change From Baseline in the Eyberg Child Behavior Inventory (ECBI) Score at Different Time Points (Baseline up to 18 Weeks)
Adjusted ECBI Intenstity Change Score
|
-7 units on a scale
Interval -17.0 to 2.0
|
-22 units on a scale
Interval -29.0 to -16.0
|
|
Change From Baseline in the Eyberg Child Behavior Inventory (ECBI) Score at Different Time Points (Baseline up to 18 Weeks)
Adjusted ECBI Problem Change Score
|
-2 units on a scale
Interval -4.0 to 0.0
|
-5 units on a scale
Interval -7.0 to -4.0
|
SECONDARY outcome
Timeframe: Mean change in scores from baseline to 14-18 weeks. Increases in scores indicate decreased risk for abuse and better outcomes.Population: Adult Adolescent Parenting Inventory (AAPI-2): assesses 5 parenting constructs:1) inappropriate expectations of child,2) lack of empathy towards child's needs,3)belief in corporal punishment, 4) reverses parent-child roles, 5) restricts child's power and independence.Range for each scale is 1-10. Lower numbers indicate higher abuse risk.
Investigators want to determine the effect of the CARE intervention on diminishing harsh parenting as measured by the Adult Adolescent Parenting Inventory-2. The Adult Adolescent Parenting Inventory-2 (AAPI-2) is a 40 item parent-report measure that assesses parenting attitudes along 5 dimensions: inappropriate expectations of children, parental lack of empathy towards children's needs, strong belief in the use of corporal punishment as a means of discipline, reversing parent-child role responsibilities, and oppressing children's power and independence. Parents respond to each item on a five point Likert Scale of Strongly Agree, Agree, Disagree, Strongly Disagree and Uncertain. This measure yields a score of 1-10 for each construct. Higher scores indicate lower risk parenting.
Outcome measures
| Measure |
No Intervention: Delayed CARE
n=40 Participants
40 child-caregiver pairs will be randomized to usual treatment plus delayed PriCARE (control). 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 and/or provided with a 1-2 page informational handout on child behavior problems from the CHOP patient care manual. Following the final interview (3-4 months after enrollment for each subject) all participants randomized to the control arm (usual treatment plus delayed PriCARE) will receive the PriCARE training, if desired
|
Experiemental: Immediate CARE
n=80 Participants
80 child-caregiver pairs will be randomized to usual treatment plus immediate PriCARE, a 6 session adaptation of the CARE group parent training. CARE was developed by Trauma Treatment Training Center and informed by the principles of Parent Child Interaction Therapy. CARE has been used in many populations including daycare providers, biological parents, and foster parents. Goals are to decrease caregiver stress, improve child behavior, and enhance the caregiver-child relationship, family stability, and wellness. CARE teaches parents to follow a child's lead thus building a connection and promoting positive behaviors. CARE focuses on giving attention to child's pro-social behavior and ignoring minor misbehavior. CARE teaches techniques for giving effective commands. The PriCARE curriculum involves 6 1-2 hour sessions over 6-8 weeks. 2 mental health providers lead PriCARE trainings for groups of 4-10 caregivers. Children do not attend PriCARE.
|
|---|---|---|
|
Changes From Baseline in Parental Disciplinary Practices Assessed at Different Time Points (Baseline up to 18 Weeks)
Expectations of Children
|
0.575 units on a scale
Standard Deviation 1.56
|
0.362 units on a scale
Standard Deviation 1.46
|
|
Changes From Baseline in Parental Disciplinary Practices Assessed at Different Time Points (Baseline up to 18 Weeks)
Parental Empathy toward Children's Needs
|
0.25 units on a scale
Standard Deviation 1.58
|
0.825 units on a scale
Standard Deviation 1.57
|
|
Changes From Baseline in Parental Disciplinary Practices Assessed at Different Time Points (Baseline up to 18 Weeks)
Use of Corporal Punishment
|
-0.25 units on a scale
Standard Deviation 1.19
|
0.2 units on a scale
Standard Deviation 1.03
|
|
Changes From Baseline in Parental Disciplinary Practices Assessed at Different Time Points (Baseline up to 18 Weeks)
Parent-Child Family Roles
|
0.425 units on a scale
Standard Deviation 1.29
|
0.875 units on a scale
Standard Deviation 1.79
|
|
Changes From Baseline in Parental Disciplinary Practices Assessed at Different Time Points (Baseline up to 18 Weeks)
Children's Power and Independence
|
-0.65 units on a scale
Standard Deviation 2.15
|
0.375 units on a scale
Standard Deviation 1.84
|
Adverse Events
No Intervention: Delayed CARE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experiemental: Immediate CARE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Joanne Wood, PI
Children's Hospital of Philadelphia
Phone: 267-426-3107
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place