Child Behavior Problems
Conditions
Keywords
Child Behavior Problems, Parent Training Program
Brief summary
The purpose of this research study is to learn whether or not a brief parenting program called Child Adult Relationship Enhancement (CARE) offered at a primary care office can help improve behavior problems in children who are 2-6 years old.
Detailed description
The study will be a randomized controlled trial (RCT) of the CARE intervention. The study will include 2-6 year old children who receive their primary care at the Children's Hospital of Philadelphia, South Philadelphia Primary Care clinic and whose caregiver and/or doctor has concern about a behavior problem in the child. The caregivers will also be subjects in the study. Child-caregiver pairs who agree to be in the study will be randomly assigned to receive the CARE training immediately or in 3-4 months. The CARE intervention will last 6 weeks and child behavior and parenting will be measured at baseline, 6-8 weeks, and 14-18 weeks. Investigators will also measure parent satisfaction with the CARE intervention. * Child Adult Relationship Enhancement (CARE) is a group parent training program. * The goals of the program are to teach parents skills that help their children successfully reach developmental milestones while increasing positive behaviors. * The program also was designed to help parents manage and decrease negative child behaviors. * Each training will be led by 2 therapists and 4-10 parents will attend the CARE program together. * Children do not attend the training but parents are encouraged to practice the skills learned at CARE between the sessions.
Interventions
BEHAVIORALImmediate CARE
CARE is a group parent training informed by the principles of Parent Child Interaction Therapy and was developed by Trauma Treatment Training Center and CHOP Policy Lab. CARE has been used in many populations including residential treatment center/domestic violence shelter staff, daycare providers, graduate students, biological parents, and foster parents/caseworkers. Goals are to decrease stress for caregivers, improve child behavior, and enhance the caregiver-child relationship, family stability, and wellness. The training teaches parents to follow a child's lead thus building a connection and promoting positive behaviors. The focus is on giving attention to child's pro-social behavior and ignoring minor misbehavior. The second phase teaches techniques for giving effective commands.
Sponsors
University of Pennsylvania
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Caregiver is 18 years or older 2. Caregiver is English speaking 3. Child is 2-6 years old 4. Caregiver reports that child has a behavior problem 5. Child attends CHOP South Philadelphia Primary Care for primary care 6. Parental/guardian permission is provided (informed consent)
Exclusion criteria
1. Child has a cognitive age less than 2 years old as determined by the referring clinician 2. Child is already receiving behavioral health therapy or medication (other than medication for Attention Deficit Hyperactivity Disorder)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Eyberg Child Behavior Inventory (ECBI) Score at Different Time Points (Baseline up to 18 Weeks) | Mean Change in ECBI Scores from Baseline to 14-18 weeks. Decreases in ECBI scores reflect improvements in behavior. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Parental Disciplinary Practices Assessed at Different Time Points (Baseline up to 18 Weeks) | Mean change in scores from baseline to 14-18 weeks. Increases in scores indicate decreased risk for abuse and better outcomes. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 80 |
| Experiemental: 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. | 160 |
| Total | 240 |
Baseline characteristics
| Characteristic | Experiemental: Immediate CARE | No Intervention: Delayed CARE | Total |
|---|---|---|---|
| Adult Adolescent Parenting Inventory 2 (AAPI2) Corporal Punishment | 5.67 units on a scale STANDARD_DEVIATION 1.78 | 5.40 units on a scale STANDARD_DEVIATION 1.37 | 5.58 units on a scale STANDARD_DEVIATION 1.66 |
| Adult Adolescent Parenting Inventory 2 (AAPI2) Empathy | 4.21 units on a scale STANDARD_DEVIATION 2.06 | 4.23 units on a scale STANDARD_DEVIATION 2.14 | 4.22 units on a scale STANDARD_DEVIATION 2.08 |
| Adult Adolescent Parenting Inventory 2 (AAPI2) Expectations | 4.66 units on a scale STANDARD_DEVIATION 1.66 | 4.45 units on a scale STANDARD_DEVIATION 1.53 | 4.59 units on a scale STANDARD_DEVIATION 1.62 |
| Adult Adolescent Parenting Inventory 2 (AAPI2) Parent-child roles | 5.16 units on a scale STANDARD_DEVIATION 2.32 | 5.30 units on a scale STANDARD_DEVIATION 2.14 | 5.21 units on a scale STANDARD_DEVIATION 2.26 |
| Adult Adolescent Parenting Inventory 2 (AAPI2) Power and independence | 5.20 units on a scale STANDARD_DEVIATION 1.93 | 5.22 units on a scale STANDARD_DEVIATION 2.12 | 5.21 units on a scale STANDARD_DEVIATION 1.99 |
| Age, Categorical <=18 years | 80 Participants | 40 Participants | 120 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 80 Participants | 40 Participants | 120 Participants |
| Caregiver relationship to child Father | 1 Participants | 0 Participants | 1 Participants |
| Caregiver relationship to child Grandmother | 5 Participants | 0 Participants | 5 Participants |
| Caregiver relationship to child Mother | 74 Participants | 40 Participants | 114 Participants |
| ECBI Intensity Scale | 153 units on a scale STANDARD_DEVIATION 39 | 139 units on a scale STANDARD_DEVIATION 39 | 149 units on a scale STANDARD_DEVIATION 40 |
| ECBI Problem Scale | 21 units on a scale STANDARD_DEVIATION 8 | 18 units on a scale STANDARD_DEVIATION 8 | 20 units on a scale STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 11 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 138 Participants | 68 Participants | 206 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 103 Participants | 54 Participants | 157 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) White | 46 Participants | 22 Participants | 68 Participants |
| Sex: Female, Male Female | 105 Participants | 58 Participants | 163 Participants |
| Sex: Female, Male Male | 55 Participants | 22 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 160 |
| other Total, other adverse events | 0 / 80 | 0 / 160 |
| serious Total, serious adverse events | 0 / 80 | 0 / 160 |
Outcome results
Primary
Change From Baseline in the Eyberg Child Behavior Inventory (ECBI) Score at Different Time Points (Baseline up to 18 Weeks)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| No Intervention: Delayed CARE | 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 |
| No Intervention: Delayed CARE | 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 |
| Experiemental: Immediate CARE | 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 | -5 units on a scale |
| Experiemental: Immediate CARE | 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 | -22 units on a scale |
Secondary
Changes From Baseline in Parental Disciplinary Practices Assessed at Different Time Points (Baseline up to 18 Weeks)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Intervention: Delayed CARE | 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 |
| No Intervention: Delayed CARE | 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 |
| No Intervention: Delayed CARE | 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 |
| No Intervention: Delayed CARE | 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 |
| No Intervention: Delayed CARE | 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 |
| Experiemental: Immediate CARE | Changes From Baseline in Parental Disciplinary Practices Assessed at Different Time Points (Baseline up to 18 Weeks) | Children's Power and Independence | 0.375 units on a scale | Standard Deviation 1.84 |
| Experiemental: Immediate CARE | Changes From Baseline in Parental Disciplinary Practices Assessed at Different Time Points (Baseline up to 18 Weeks) | Parental Empathy toward Children's Needs | 0.825 units on a scale | Standard Deviation 1.57 |
| Experiemental: Immediate CARE | Changes From Baseline in Parental Disciplinary Practices Assessed at Different Time Points (Baseline up to 18 Weeks) | Use of Corporal Punishment | 0.2 units on a scale | Standard Deviation 1.03 |
| Experiemental: Immediate CARE | Changes From Baseline in Parental Disciplinary Practices Assessed at Different Time Points (Baseline up to 18 Weeks) | Parent-Child Family Roles | 0.875 units on a scale | Standard Deviation 1.79 |
| Experiemental: Immediate CARE | Changes From Baseline in Parental Disciplinary Practices Assessed at Different Time Points (Baseline up to 18 Weeks) | Expectations of Children | 0.362 units on a scale | Standard Deviation 1.46 |