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Improving Parent-Child Interactions to Enhance Child Health

Improving Parent-Child Interactions to Prevent Child Obesity in Early Childhood

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03982511
Acronym
PCIT-Health
Enrollment
63
Registered
2019-06-11
Start date
2019-05-29
Completion date
2022-04-08
Last updated
2023-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Obesity

Brief summary

Childhood obesity is a formidable public health issue in the United States, disproportionately affecting children from lower socioeconomic status households. Onset of obesity predicts cardiometabolic risks and other health problems in adolescence and into adulthood; thus, effective and early prevention is critical. Healthy parenting may play a pivotal role in preventing early childhood obesity. Warm, responsive, and consistent parenting is associated with the development of child self-regulation as well as healthy eating and physical activity practices, and thus may be protective against obesity risk. Targeting the parent-child relationship may be especially important when facilitating behavior change in parents who have ongoing stressors (e.g., low-income families). The proposed study aims to test an adaptation of Parent-Child Interaction Therapy (PCIT), an innovative parent management program that improves the parent-child relationship and enhances general parenting skills through the use of therapeutic in vivo coaching. Our adapted version, PCIT-Health, is a selective-prevention intervention that includes content specific to improving parent-child interactions and parenting in obesity-salient contexts, such as mealtime and child screen time. This project will elucidate novel approaches to, and novel targets of, early childhood obesity prevention and will provide data critical to test PCIT-Health in a large-scale randomized controlled trial. Parent-child dyads will be randomly assigned to PCIT-Health or a waitlist control in order to accomplish the following aims: AIM 1: To assess the acceptability and feasibility of the PCIT-Health delivery and assessment methods in low-income parents of overweight young children ages 3 to 6 years. AIM 2: To test the preliminary efficacy and estimate the effect size of PCIT-Health on changes in child BMI z-score (primary outcome) from baseline to (1) intervention completion and (2) 6-month post-intervention. AIM 3: To explore the effect of PCIT-Health on the following secondary outcomes: (1) parent-child relationship quality, (2) parent behavior management skills, (3) child self-regulation, (4) child eating behaviors, (5) child physical activity, and (6) child screen media use.

Interventions

BEHAVIORALPCIT-Health

PCIT-Health (also known as Parents Active in Their Children's Health; PATCH) is an adaptation of Parent-Child Interaction Therapy. PCIT-Health targets (1) the parent-child relationship and (2) parenting efficacy both in general contexts (child play time and clean up time) and specifically in the context of obesity risk-related behaviors (child feeding, family mealtime, and child screen time).

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Michigan
CollaboratorOTHER
Central Michigan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Behavioral observation coders are masked.

Intervention model description

Parent-child dyads will be randomly assigned to PCIT-Health or a waitlist control.

Eligibility

Sex/Gender
ALL
Age
30 Months to 84 Months
Healthy volunteers
Yes

Inclusion criteria

* child BMI \> 5th percentile * child born at 37+ weeks gestation, with no significant neo- or perinatal complications.

Exclusion criteria

* Child is experiencing clinical levels of behavior problems * History of food allergies or medical problems or medications affecting appetite or weight * Non-fluency in English * Significant child or parent developmental delay * Child currently in State custody * Family currently involved with Child Protective Services * Caregiver is receiving or has plans to receive other behavioral parenting interventions

Design outcomes

Primary

MeasureTime frameDescription
Change in Child Body Mass Index (BMI) Z-scorePre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Change in child BMI z-score will be calculated using standardized anthropometric measurement (height and weight) procedure. The z-score is a standard deviation away from the mean, based on the CDC growth charts. Higher z-scores indicate greater weight status. A Z-score of 0 equals the population mean, based on age and sex.
Change in Child Body Mass Index (BMI) PercentilePre-intervention (T1), post-intervention (T2;4 months after pre-intervention), and six-month follow-up (T3;10 months after pre-intervention)Change in child BMI percentile will be calculated using standardized anthropometric measurement (height and weight) procedure

Secondary

MeasureTime frameDescription
Child Screen TimePre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Parent report of weekly amount of time child spends viewing/using screen media. Scores range from 0-168, with total scores reflecting sum of daily screen time across multiple types of screen media. Higher scores = more screen time.
Child Physical ActivityPre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Measured by Actigraph accelerometer to assess sedentary, moderate, moderate-to-vigorous, and vigorous physical activity (MVPA)
Child Sleep (Parent Report)Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Measured by parent report of bedtime, wake time, and naps.
Child Sleep (Via Actigraphy)Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Measured by Actigraph accelerometer.
Child Problematic Media UsePre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Measured by the parent-report via Problematic Media Use Measure (Domoff et al., 2019). Higher scores = greater problematic media use. Total scores = mean of items; Min = 1 to Max = 5.
Restrictive Mediation of Television (Parent-report)Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Scores on the Restrictive Mediation subscale of the Parental Mediation Scale (Valkenburg et al., 1999) will be calculated via sum score of 5 items. Min = 5, max = 20, higher scores = better outcome.
Parent-child Relationship Quality (Observed)Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Dyadic Parent-Child Interaction Coding System-IV (DPICS-IV) will be used. The DPICS provides a reliable measure of parent-child relationship quality (e.g., parents' child-centered skills, parent and child positive and negative physical and verbal interactions) and parent behavior management skills (e.g., use of contingent reinforcement, effective discipline, child compliance). This outcome reflects behavioral observation of parents' child-centered skills (DO skills) during child led play. This is a count variable that can range from 0 displayed skills (min) with no determined maximum. Higher numbers = more skills (better outcome).
Parent-child Relationship Quality (Parent Report)Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Scores on the Parent-child Dysfunctional Interaction (PCDI) subscale of the Parenting Stress Index will be used as the parent-report of parent-child relationship quality. Values range from 12 to 60, with higher scores indicating greater dysfunction in (poorer quality of) the parent-child relationship.
Child Self-regulation (Parent Report)Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Emotion Regulation (ER) Checklist, higher scores = greater regulation (better outcome). Mean calculation for total score, with Min=1 to Max=4
Location/Quantity of Screen Media in the Home (Parent-report)Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Parents will report on the location/quantity of screen media in home and child's bedroom.
Media Parenting Practices (Observed)Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Family mealtime observations will be coded for presence and use of screen media (TV, mobile device present, other media present). Coding of the observed behavior is as follows: TV on = 1 if TV is on during mealtime, TV on = 0 if TV is off during mealtime, lower values = better outcomes. Mobile device present = 1 if a mobile device is present, 0 if no mobile device is present, with lower values= better outcomes. Other media present = 1 if other screens are present, 0 if no other screens are present (lower values=better outcomes).
Parent Feeding Practices (Observed)Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Family mealtime observations will be coded using a modified version of the Mealtime Interaction Coding System. Aspects of task accomplishment (TA) and behavior control BC) were coded. Scores could range from 1 (min) to 3 (max), with higher scores = better outcomes.
Pressure to Eat (Parent-report)Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Scores on the Child Feeding Questionnaire (CFQ)- Pressure to Eat subscale will be calculated. This subscale score is a mean, with minimum of 1 and maximum of 5 (higher scores = more pressure to eat, a worse outcome).
Restriction (Parent-report)Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Scores on the Child Feeding Questionnaire (CFQ)-Restriction subscale will be calculated. A mean is calculated for this subscale (min = 1 to max = 5). Higher scores = greater restriction of food (poorer outcome).
Emotional Feeding (Parent-report)Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Child Feeding Questionnaire (CFQ)- Emotional Feeding subscale will be calculated with a mean of responses to items. Min = 1 to max = 5. Higher scores reflect worse outcome.
Instrumental Feeding (Parent-report)Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Scores on the Parental Feeding Questionnaire (PFQ)- Instrumental Feeding subscale will be calculated. Mean calculation of responses, with scores ranging from 1 (min) to 5 (max). Higher scores reflect poorer outcome.
Active Mediation of Television (Parent-report)Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Scores on the Instructive Mediation subscale of the Parental Mediation Scale (Valkenburg et al., 1999) will be calculated via sum score of 5 items. Min = 5, max = 20, higher scores = better outcome.
Social Coviewing of Television (Parent-report)Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Scores on the Social Coviewing subscale of the Parental Mediation Scale (Valkenburg et al., 1999) will be calculated via sum score of 5 items. Min = 5, max = 20, higher scores = better outcome.

Other

MeasureTime frameDescription
Child Disruptive Behaviors (Parent Report)Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Eyberg Child Behavior Inventory (ECBI); intensity t-score. Higher t-scores indicate poorer outcomes (i.e., greater intensity of behavior problems). T-scores have a mean of 50 (SD = 10). T-scores of 60 or higher indicate clinical significance.
Child Psychological Functioning (Parent Report)Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Behavior Assessment System for Children (BASC-3); internalizing symptoms t-score (lower scores better outcome) and adaptive skills t-score (higher scores better outcome). T-scores M = 50, SD = 10, with clinical cut-offs at 70 or above.
Child Psychosocial Strengths (Parent Report)Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)Psychosocial Strengths Inventory for Children and Adolescents (PSICA). Scores reflect total sum, ranging from 36 (min) to 252 (max); higher scores indicate better outcomes.

Countries

United States

Participant flow

Pre-assignment details

After enrollment (providing consent), but before assignment, two families declined to continue participating in the study. (n = 4).

Participants by arm

ArmCount
PCIT-Health
Participants assigned to the PCIT-Health arm will receive the intervention. PCIT-Health: PCIT-Health (also known as Parents Active in Their Children's Health; PATCH) is an adaptation of Parent-Child Interaction Therapy. PCIT-Health targets (1) the parent-child relationship and (2) parenting efficacy both in general contexts (child play time and clean up time) and specifically in the context of obesity risk-related behaviors (child feeding, family mealtime, and child screen time). Due to the pandemic, telehealth PCIT-Health was provided to most of the participants.
41
Wait List Control
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
18
Total59

Baseline characteristics

CharacteristicPCIT-HealthWait List ControlTotal
Age, Categorical
Caregiver
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
Caregiver
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Caregiver
Between 18 and 65 years
27 Participants11 Participants38 Participants
Age, Categorical
Child
<=18 years
14 Participants7 Participants21 Participants
Age, Categorical
Child
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Child
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous53.36 months
STANDARD_DEVIATION 16.06
50.86 months
STANDARD_DEVIATION 11.95
52.52 months
STANDARD_DEVIATION 14.56
BMI percentile68.09 percentile
STANDARD_DEVIATION 30.5
73.94 percentile
STANDARD_DEVIATION 26.52
70.04 percentile
STANDARD_DEVIATION 28.7
Body Mass Index (BMI) z-score0.71 Z-score
STANDARD_DEVIATION 1.21
0.77 Z-score
STANDARD_DEVIATION 0.84
0.73 Z-score
STANDARD_DEVIATION 1.08
Ethnicity (NIH/OMB)
Caregiver
Hispanic or Latino
1 Participants1 Participants2 Participants
Ethnicity (NIH/OMB)
Caregiver
Not Hispanic or Latino
26 Participants10 Participants36 Participants
Ethnicity (NIH/OMB)
Caregiver
Unknown or Not Reported
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Child
Hispanic or Latino
1 Participants2 Participants3 Participants
Ethnicity (NIH/OMB)
Child
Not Hispanic or Latino
13 Participants5 Participants18 Participants
Ethnicity (NIH/OMB)
Child
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Caregiver
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Caregiver
Asian
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Caregiver
Black or African American
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Caregiver
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Caregiver
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Caregiver
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Caregiver
White
23 Participants11 Participants34 Participants
Race (NIH/OMB)
Child
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Child
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Child
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Child
More than one race
1 Participants2 Participants3 Participants
Race (NIH/OMB)
Child
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Child
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Child
White
12 Participants5 Participants17 Participants
Region of Enrollment
United States
41 participants18 participants59 participants
Sex: Female, Male
Caregiver
Female
16 Participants8 Participants24 Participants
Sex: Female, Male
Caregiver
Male
11 Participants3 Participants14 Participants
Sex: Female, Male
Child
Female
5 Participants3 Participants8 Participants
Sex: Female, Male
Child
Male
9 Participants4 Participants13 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 410 / 18
other
Total, other adverse events
0 / 410 / 18
serious
Total, serious adverse events
0 / 410 / 18

Outcome results

Primary

Change in Child Body Mass Index (BMI) Percentile

Change in child BMI percentile will be calculated using standardized anthropometric measurement (height and weight) procedure

Time frame: Pre-intervention (T1), post-intervention (T2;4 months after pre-intervention), and six-month follow-up (T3;10 months after pre-intervention)

Population: For Time 2, n = 11 for PCIT-health and n = 7 for control. For Time 3, n = 9 for PCIT-health and n = 6 for control.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthChange in Child Body Mass Index (BMI) PercentileChange in BMI percentile (T2-T1); negative values indicate decrease in BMI percentile3.66 percentileStandard Error 2.29
PCIT-HealthChange in Child Body Mass Index (BMI) PercentileChange in BMI percentile (T3-T1); negative values indicate decrease in BMI percentile1.12 percentileStandard Error 2.56
Wait List ControlChange in Child Body Mass Index (BMI) PercentileChange in BMI percentile (T2-T1); negative values indicate decrease in BMI percentile1.74 percentileStandard Error 3.24
Wait List ControlChange in Child Body Mass Index (BMI) PercentileChange in BMI percentile (T3-T1); negative values indicate decrease in BMI percentile0.88 percentileStandard Error 3.72
Comparison: Difference on difference from T2 to T1 for BMI z-scorep-value: 0.73ANOVA
Comparison: Difference on difference for BMI z-score from T3 to T1p-value: 0.98ANOVA
Comparison: Difference on difference for BMI percentile from T2 to T1p-value: 0.63ANOVA
Comparison: Difference on difference for BMI percentile from T3 to T1p-value: 0.96ANOVA
Primary

Change in Child Body Mass Index (BMI) Z-score

Change in child BMI z-score will be calculated using standardized anthropometric measurement (height and weight) procedure. The z-score is a standard deviation away from the mean, based on the CDC growth charts. Higher z-scores indicate greater weight status. A Z-score of 0 equals the population mean, based on age and sex.

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: For Time 2, n = 11 for PCIT-health and n = 7 for control. For Time 3, n = 9 for PCIT-health and n = 6 for control.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthChange in Child Body Mass Index (BMI) Z-scoreChange in BMI z-score (T2-T1); negative values indicate decrease in BMI z-score0.11 Z-scoreStandard Error 0.08
PCIT-HealthChange in Child Body Mass Index (BMI) Z-scoreChange in BMI z-score (T3-T1); negative values indicate decrease in BMI z-score0.01 Z-scoreStandard Error 0.1
Wait List ControlChange in Child Body Mass Index (BMI) Z-scoreChange in BMI z-score (T2-T1); negative values indicate decrease in BMI z-score0.06 Z-scoreStandard Error 0.12
Wait List ControlChange in Child Body Mass Index (BMI) Z-scoreChange in BMI z-score (T3-T1); negative values indicate decrease in BMI z-score0.02 Z-scoreStandard Error 0.15
Comparison: Difference on difference from T2 to T1 for BMI z-scorep-value: 0.73ANOVA
Comparison: Difference on difference for BMI z-scores from T3 to T1.p-value: 0.98ANOVA
Secondary

Active Mediation of Television (Parent-report)

Scores on the Instructive Mediation subscale of the Parental Mediation Scale (Valkenburg et al., 1999) will be calculated via sum score of 5 items. Min = 5, max = 20, higher scores = better outcome.

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthActive Mediation of Television (Parent-report)Change in active mediation from T2 to T12.86 score on a scaleStandard Error 0.61
PCIT-HealthActive Mediation of Television (Parent-report)Change in active mediation from T3 to T12.95 score on a scaleStandard Error 0.84
Wait List ControlActive Mediation of Television (Parent-report)Change in active mediation from T2 to T10.64 score on a scaleStandard Error 0.86
Wait List ControlActive Mediation of Television (Parent-report)Change in active mediation from T3 to T10.44 score on a scaleStandard Error 1.21
Comparison: Difference on difference for active mediation from T2 to T1p-value: 0.05ANOVA
Comparison: Difference on difference for active mediation scores from T3 to T1p-value: 0.11ANOVA
Secondary

Child Physical Activity

Measured by Actigraph accelerometer to assess sedentary, moderate, moderate-to-vigorous, and vigorous physical activity (MVPA)

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Smaller n due to incomplete data (not wearing actigraph for minimum number of days).

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthChild Physical ActivityChange in Moderate-Vigorous Physical Activity minutes from T2 to T1 (higher scores = more activity)38.26 minutesStandard Error 13.78
PCIT-HealthChild Physical ActivityChange in Moderate-Vigorous Physical Activity minutes from T3 to T1 (higher scores = more activity)32.55 minutesStandard Error 18.4
PCIT-HealthChild Physical ActivityChange in Sedentary minutes from T2 to T1 (higher scores = less activity)-59.17 minutesStandard Error 31.46
PCIT-HealthChild Physical ActivityChange in Sedentary minutes from T3 to T1 (higher scores = less activity)14.59 minutesStandard Error 40.32
Wait List ControlChild Physical ActivityChange in Sedentary minutes from T3 to T1 (higher scores = less activity)-51.65 minutesStandard Error 52.79
Wait List ControlChild Physical ActivityChange in Moderate-Vigorous Physical Activity minutes from T2 to T1 (higher scores = more activity)2.94 minutesStandard Error 19.48
Wait List ControlChild Physical ActivityChange in Sedentary minutes from T2 to T1 (higher scores = less activity)5.23 minutesStandard Error 44.5
Wait List ControlChild Physical ActivityChange in Moderate-Vigorous Physical Activity minutes from T3 to T1 (higher scores = more activity)16.46 minutesStandard Error 24.09
Comparison: Difference on difference score for MVPA minutes from T2 to T1p-value: 0.16ANOVA
Comparison: Difference on difference score for MVPA minutes from T3 to T1p-value: 0.61ANOVA
Comparison: Difference on difference score for sedentary minutes from T2 to T1p-value: 0.26ANOVA
Comparison: Difference on difference score for sedentary minutes from T3 to T1p-value: 0.34ANOVA
Secondary

Child Problematic Media Use

Measured by the parent-report via Problematic Media Use Measure (Domoff et al., 2019). Higher scores = greater problematic media use. Total scores = mean of items; Min = 1 to Max = 5.

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data. Higher scores indicate higher problematic media use.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthChild Problematic Media UseChange in problematic media use from T2 to T1-0.30 units on a scaleStandard Error 0.15
PCIT-HealthChild Problematic Media UseChange in problematic media use from T3 to T1-0.36 units on a scaleStandard Error 0.16
Wait List ControlChild Problematic Media UseChange in problematic media use from T2 to T1-0.38 units on a scaleStandard Error 0.21
Wait List ControlChild Problematic Media UseChange in problematic media use from T3 to T1-0.15 units on a scaleStandard Error 0.23
Comparison: Difference on difference for problematic media use from T2 to T1p-value: 0.77ANOVA
Comparison: Difference on difference for problematic media use from T3 to T1p-value: 0.47ANOVA
Secondary

Child Screen Time

Parent report of weekly amount of time child spends viewing/using screen media. Scores range from 0-168, with total scores reflecting sum of daily screen time across multiple types of screen media. Higher scores = more screen time.

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthChild Screen TimeChange in weekly screen time from T2 to T1-5.72 Hours per weekStandard Deviation 12.52
PCIT-HealthChild Screen TimeChange in weekly screen time from T3 to T1-2.92 Hours per weekStandard Deviation 12.08
Wait List ControlChild Screen TimeChange in weekly screen time from T2 to T10.36 Hours per weekStandard Deviation 18.37
Wait List ControlChild Screen TimeChange in weekly screen time from T3 to T1-8.75 Hours per weekStandard Deviation 26.62
Comparison: Difference on difference for child weekly screen time from T2 to T1p-value: 0.28ANOVA
Comparison: Difference on difference for child weekly screen time from T3 to T1p-value: 0.43ANOVA
Secondary

Child Self-regulation (Parent Report)

Emotion Regulation (ER) Checklist, higher scores = greater regulation (better outcome). Mean calculation for total score, with Min=1 to Max=4

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthChild Self-regulation (Parent Report)Change from T2 to T1 on ER subscale0.23 units on a scaleStandard Deviation 0.31
PCIT-HealthChild Self-regulation (Parent Report)Change from T3 to T1 on ER subscale0.26 units on a scaleStandard Deviation 0.29
Wait List ControlChild Self-regulation (Parent Report)Change from T2 to T1 on ER subscale0.03 units on a scaleStandard Deviation 0.38
Wait List ControlChild Self-regulation (Parent Report)Change from T3 to T1 on ER subscale0.26 units on a scaleStandard Deviation 0.42
Comparison: Difference on difference for Emotion regulation subscale from T2 to T1p-value: 0.12ANOVA
Comparison: Difference on difference for emotion regulation subscale from T3 to T1p-value: 0.96ANOVA
Secondary

Child Sleep (Parent Report)

Measured by parent report of bedtime, wake time, and naps.

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthChild Sleep (Parent Report)Change in hours of sleep from T2 to T1-1.0 hoursStandard Deviation 2.25
PCIT-HealthChild Sleep (Parent Report)Change in hours of sleep from T3 to T1-1.05 hoursStandard Deviation 2.68
Wait List ControlChild Sleep (Parent Report)Change in hours of sleep from T2 to T1-0.36 hoursStandard Deviation 1.5
Wait List ControlChild Sleep (Parent Report)Change in hours of sleep from T3 to T1-2.44 hoursStandard Deviation 1.33
Comparison: Difference on difference for parent-reported sleep time from T2 to T1p-value: 0.41ANOVA
Comparison: Difference on difference for parent-reported sleep time from T3 to T1p-value: 0.16ANOVA
Secondary

Child Sleep (Via Actigraphy)

Measured by Actigraph accelerometer.

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Incomplete actigraphy data due to participants wearing actigraph for fewer than minimum required days needed to calculate sleep.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthChild Sleep (Via Actigraphy)Change in minutes of sleep from T2 to T1-10.15 hoursStandard Error 8.19
PCIT-HealthChild Sleep (Via Actigraphy)Change in minutes of sleep from T3 to T1-29.54 hoursStandard Error 10.1
Wait List ControlChild Sleep (Via Actigraphy)Change in minutes of sleep from T2 to T12.47 hoursStandard Error 12.38
Wait List ControlChild Sleep (Via Actigraphy)Change in minutes of sleep from T3 to T19.29 hoursStandard Error 13.22
Comparison: Difference on difference for actigraphy-recorded sleep time from T2 to T1p-value: 0.42ANOVA
Comparison: Difference on difference for actigraphy-recorded sleep time from T3 to T1p-value: 0.04ANOVA
Secondary

Emotional Feeding (Parent-report)

Child Feeding Questionnaire (CFQ)- Emotional Feeding subscale will be calculated with a mean of responses to items. Min = 1 to max = 5. Higher scores reflect worse outcome.

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthEmotional Feeding (Parent-report)Change in emotional feeding from T2 to T1-0.19 score on a scaleStandard Error 0.13
PCIT-HealthEmotional Feeding (Parent-report)Change in emotional feeding from T3 to T1-0.37 score on a scaleStandard Error 0.12
Wait List ControlEmotional Feeding (Parent-report)Change in emotional feeding from T2 to T1-0.16 score on a scaleStandard Error 0.19
Wait List ControlEmotional Feeding (Parent-report)Change in emotional feeding from T3 to T1-0.20 score on a scaleStandard Error 0.18
Comparison: Difference on difference for emotional feeding scores from T2 to T1p-value: 0.91ANOVA
Comparison: Difference on difference for emotional feeding scores from T3 to T1p-value: 0.45ANOVA
Secondary

Instrumental Feeding (Parent-report)

Scores on the Parental Feeding Questionnaire (PFQ)- Instrumental Feeding subscale will be calculated. Mean calculation of responses, with scores ranging from 1 (min) to 5 (max). Higher scores reflect poorer outcome.

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthInstrumental Feeding (Parent-report)Change in instrumental feeding from T2 to T1-0.74 score on a scaleStandard Error 0.12
PCIT-HealthInstrumental Feeding (Parent-report)Change in instrumental feeding from T3 to T1-0.91 score on a scaleStandard Error 0.13
Wait List ControlInstrumental Feeding (Parent-report)Change in instrumental feeding from T2 to T1-0.27 score on a scaleStandard Error 0.16
Wait List ControlInstrumental Feeding (Parent-report)Change in instrumental feeding from T3 to T1-0.36 score on a scaleStandard Error 0.19
Comparison: Difference on difference for instrumental feeding scores from T2 to T1.p-value: 0.03ANOVA
Comparison: Difference on difference for instrumental feeding scores from T3 to T1p-value: 0.03ANOVA
Secondary

Location/Quantity of Screen Media in the Home (Parent-report)

Parents will report on the location/quantity of screen media in home and child's bedroom.

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthLocation/Quantity of Screen Media in the Home (Parent-report)Change in number of screens in the home from T2 to T10.32 number of screensStandard Error 0.89
PCIT-HealthLocation/Quantity of Screen Media in the Home (Parent-report)Change in number of screens in the home from T3 to T10.49 number of screensStandard Error 0.94
PCIT-HealthLocation/Quantity of Screen Media in the Home (Parent-report)Change in number of screens in the child's bedroom from T2 to T1-0.21 number of screensStandard Error 0.22
PCIT-HealthLocation/Quantity of Screen Media in the Home (Parent-report)Change in number of screens in the child's bedroom from T3 to T1-0.58 number of screensStandard Error 0.22
Wait List ControlLocation/Quantity of Screen Media in the Home (Parent-report)Change in number of screens in the child's bedroom from T3 to T10.33 number of screensStandard Error 0.32
Wait List ControlLocation/Quantity of Screen Media in the Home (Parent-report)Change in number of screens in the home from T2 to T10.18 number of screensStandard Error 1.18
Wait List ControlLocation/Quantity of Screen Media in the Home (Parent-report)Change in number of screens in the child's bedroom from T2 to T10.19 number of screensStandard Error 0.3
Wait List ControlLocation/Quantity of Screen Media in the Home (Parent-report)Change in number of screens in the home from T3 to T1-0.39 number of screensStandard Error 1.3
Comparison: Difference on difference for number of screens in the home from T2 to T1p-value: 0.91ANOVA
Comparison: Difference on difference for number of screens in the home from T3 to T1p-value: 0.64ANOVA
Comparison: Difference on difference for number of screens in child bedroom from T2 to T1p-value: 0.31ANOVA
Comparison: Difference on difference for number of screens in child bedroom from T3 to T1p-value: 0.04ANOVA
Secondary

Media Parenting Practices (Observed)

Family mealtime observations will be coded for presence and use of screen media (TV, mobile device present, other media present). Coding of the observed behavior is as follows: TV on = 1 if TV is on during mealtime, TV on = 0 if TV is off during mealtime, lower values = better outcomes. Mobile device present = 1 if a mobile device is present, 0 if no mobile device is present, with lower values= better outcomes. Other media present = 1 if other screens are present, 0 if no other screens are present (lower values=better outcomes).

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Family mealtime recordings were provided by one caregiver.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthMedia Parenting Practices (Observed)Change in TV on during mealtime from T2 to T1-0.39 score on a scaleStandard Error 0.11
PCIT-HealthMedia Parenting Practices (Observed)Change in TV on during mealtime from T3 to T1-0.33 score on a scaleStandard Error 0.1
PCIT-HealthMedia Parenting Practices (Observed)Change in mobile device present during mealtime from T2 to T1-0.09 score on a scaleStandard Error 0.12
PCIT-HealthMedia Parenting Practices (Observed)Change in mobile device present during mealtime from T3 to T10.00 score on a scaleStandard Error 0.11
PCIT-HealthMedia Parenting Practices (Observed)Change in other media present during mealtime from T2 to T1-0.17 score on a scaleStandard Error 0.08
PCIT-HealthMedia Parenting Practices (Observed)Change in other media present during mealtime from T3 to T1-0.22 score on a scaleStandard Error 0.09
Wait List ControlMedia Parenting Practices (Observed)Change in other media present during mealtime from T2 to T10.22 score on a scaleStandard Error 0.13
Wait List ControlMedia Parenting Practices (Observed)Change in TV on during mealtime from T2 to T10.11 score on a scaleStandard Error 0.18
Wait List ControlMedia Parenting Practices (Observed)Change in mobile device present during mealtime from T3 to T10.29 score on a scaleStandard Error 0.18
Wait List ControlMedia Parenting Practices (Observed)Change in TV on during mealtime from T3 to T10.00 score on a scaleStandard Error 0.16
Wait List ControlMedia Parenting Practices (Observed)Change in other media present during mealtime from T3 to T10.0 score on a scaleStandard Error 0.14
Wait List ControlMedia Parenting Practices (Observed)Change in mobile device present during mealtime from T2 to T10.11 score on a scaleStandard Error 0.2
Comparison: Difference on difference for TV on during mealtime from T2 to T1p-value: 0.03ANOVA
Comparison: Difference on difference for TV on during mealtime from T3 to T1p-value: 0.1ANOVA
Comparison: Difference on difference for mobile device present during mealtime from T2 to T1p-value: 0.41ANOVA
Comparison: Difference on difference for mobile device present during mealtime from T3 to T1p-value: 0.21ANOVA
Comparison: Difference on difference for other media present during mealtime from T2 to T1p-value: 0.02ANOVA
Comparison: Difference on difference for other media present during mealtime from T3 to T1p-value: 0.2ANOVA
Secondary

Parent-child Relationship Quality (Observed)

Dyadic Parent-Child Interaction Coding System-IV (DPICS-IV) will be used. The DPICS provides a reliable measure of parent-child relationship quality (e.g., parents' child-centered skills, parent and child positive and negative physical and verbal interactions) and parent behavior management skills (e.g., use of contingent reinforcement, effective discipline, child compliance). This outcome reflects behavioral observation of parents' child-centered skills (DO skills) during child led play. This is a count variable that can range from 0 displayed skills (min) with no determined maximum. Higher numbers = more skills (better outcome).

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthParent-child Relationship Quality (Observed)Change in child-centered skills from T2 to T17.65 SkillsStandard Error 1.57
PCIT-HealthParent-child Relationship Quality (Observed)Change in child-centered skills from T3 to T16.35 SkillsStandard Error 1.99
Wait List ControlParent-child Relationship Quality (Observed)Change in child-centered skills from T2 to T10.00 SkillsStandard Error 2.12
Wait List ControlParent-child Relationship Quality (Observed)Change in child-centered skills from T3 to T1-0.11 SkillsStandard Error 2.73
Comparison: Difference on difference for child-centered skills from T2 to T1p-value: 0.005ANOVA
Comparison: Difference on difference for child-centered skills from T3 to T1p-value: 0.05ANOVA
Secondary

Parent-child Relationship Quality (Parent Report)

Scores on the Parent-child Dysfunctional Interaction (PCDI) subscale of the Parenting Stress Index will be used as the parent-report of parent-child relationship quality. Values range from 12 to 60, with higher scores indicating greater dysfunction in (poorer quality of) the parent-child relationship.

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthParent-child Relationship Quality (Parent Report)Change in PCDI from T2 to T1-9.59 score on a scaleStandard Error 4
PCIT-HealthParent-child Relationship Quality (Parent Report)Change in PCDI from T3 to T1-13.21 score on a scaleStandard Error 3.63
Wait List ControlParent-child Relationship Quality (Parent Report)Change in PCDI from T2 to T17.64 score on a scaleStandard Error 5.66
Wait List ControlParent-child Relationship Quality (Parent Report)Change in PCDI from T3 to T16.22 score on a scaleStandard Error 5.27
Comparison: Difference on difference for PCDI scores from T2 to T1.p-value: 0.02ANOVA
Comparison: Difference on difference for PCDI scores from T3 to T1p-value: 0.008ANOVA
Secondary

Parent Feeding Practices (Observed)

Family mealtime observations will be coded using a modified version of the Mealtime Interaction Coding System. Aspects of task accomplishment (TA) and behavior control BC) were coded. Scores could range from 1 (min) to 3 (max), with higher scores = better outcomes.

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: One caregiver submitted family mealtime observations per family.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthParent Feeding Practices (Observed)Change in TA score during mealtime from T2 to T10.09 score on a scaleStandard Error 0.07
PCIT-HealthParent Feeding Practices (Observed)Change in TA score during mealtime from T3 to T10.11 score on a scaleStandard Error 0.08
PCIT-HealthParent Feeding Practices (Observed)Change in BC score during mealtime from T2 to T10.13 score on a scaleStandard Error 0.1
PCIT-HealthParent Feeding Practices (Observed)Change in BC score during mealtime from T3 to T10.11 score on a scaleStandard Error 0.08
Wait List ControlParent Feeding Practices (Observed)Change in BC score during mealtime from T3 to T10.14 score on a scaleStandard Error 0.13
Wait List ControlParent Feeding Practices (Observed)Change in TA score during mealtime from T2 to T1-0.33 score on a scaleStandard Error 0.12
Wait List ControlParent Feeding Practices (Observed)Change in BC score during mealtime from T2 to T1-0.11 score on a scaleStandard Error 0.17
Wait List ControlParent Feeding Practices (Observed)Change in TA score during mealtime from T3 to T10.14 score on a scaleStandard Error 0.13
Comparison: Difference on difference for mealtime task accomplishment scores from T2 to T1p-value: 0.009ANOVA
Comparison: Difference on difference for mealtime task accomplishment scores from T3 to T1p-value: 0.84ANOVA
Comparison: Difference on difference for mealtime behavior control scores from T2 to T1p-value: 0.24ANOVA
Comparison: Difference on difference for mealtime behavior control scores from T3 to T1.p-value: 0.84ANOVA
Secondary

Pressure to Eat (Parent-report)

Scores on the Child Feeding Questionnaire (CFQ)- Pressure to Eat subscale will be calculated. This subscale score is a mean, with minimum of 1 and maximum of 5 (higher scores = more pressure to eat, a worse outcome).

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthPressure to Eat (Parent-report)Change in pressure to eat scores from T2 to T1-0.84 score on a scaleStandard Error 0.21
PCIT-HealthPressure to Eat (Parent-report)Change in pressure to eat scores from T3 to T1-0.59 score on a scaleStandard Error 0.21
Wait List ControlPressure to Eat (Parent-report)Change in pressure to eat scores from T2 to T1-0.59 score on a scaleStandard Error 0.29
Wait List ControlPressure to Eat (Parent-report)Change in pressure to eat scores from T3 to T1-0.58 score on a scaleStandard Error 0.31
Comparison: Difference on difference for pressure to eat scores from T2 to T1p-value: 0.5ANOVA
Comparison: Difference on difference for pressure to eat scores from T3 to T1p-value: 0.98ANOVA
Secondary

Restriction (Parent-report)

Scores on the Child Feeding Questionnaire (CFQ)-Restriction subscale will be calculated. A mean is calculated for this subscale (min = 1 to max = 5). Higher scores = greater restriction of food (poorer outcome).

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthRestriction (Parent-report)Change in Restriction scores from T2 to T1-0.71 score on a scaleStandard Error 0.18
PCIT-HealthRestriction (Parent-report)Change in Restriction scores from T3 to T1-0.88 score on a scaleStandard Error 0.2
Wait List ControlRestriction (Parent-report)Change in Restriction scores from T2 to T1-0.25 score on a scaleStandard Error 0.26
Wait List ControlRestriction (Parent-report)Change in Restriction scores from T3 to T1-0.53 score on a scaleStandard Error 0.29
Comparison: Difference on difference for restrictive feeding scores from T2 to T1p-value: 0.17ANOVA
Comparison: Difference on difference for restrictive feeding scores from T3 to T1p-value: 0.34ANOVA
Secondary

Restrictive Mediation of Television (Parent-report)

Scores on the Restrictive Mediation subscale of the Parental Mediation Scale (Valkenburg et al., 1999) will be calculated via sum score of 5 items. Min = 5, max = 20, higher scores = better outcome.

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthRestrictive Mediation of Television (Parent-report)Change in restrictive mediation from T2 to T12.36 score on a scaleStandard Error 0.57
PCIT-HealthRestrictive Mediation of Television (Parent-report)Change in restrictive mediation from T3 to T11.53 score on a scaleStandard Error 0.61
Wait List ControlRestrictive Mediation of Television (Parent-report)Change in restrictive mediation from T2 to T1-1.27 score on a scaleStandard Error 0.81
Wait List ControlRestrictive Mediation of Television (Parent-report)Change in restrictive mediation from T3 to T10.22 score on a scaleStandard Error 0.89
Comparison: Difference on difference for restrictive mediation scores from T2 to T1p-value: 0.002ANOVA
Comparison: Difference on difference for restrictive mediation scores from T3 to T1p-value: 0.24ANOVA
Secondary

Social Coviewing of Television (Parent-report)

Scores on the Social Coviewing subscale of the Parental Mediation Scale (Valkenburg et al., 1999) will be calculated via sum score of 5 items. Min = 5, max = 20, higher scores = better outcome.

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthSocial Coviewing of Television (Parent-report)Change in social coviewing from T2 to T11.14 score on a scaleStandard Error 0.61
PCIT-HealthSocial Coviewing of Television (Parent-report)Change in social coviewing from T3 to T11.11 score on a scaleStandard Error 0.63
Wait List ControlSocial Coviewing of Television (Parent-report)Change in social coviewing from T2 to T10.45 score on a scaleStandard Error 0.86
Wait List ControlSocial Coviewing of Television (Parent-report)Change in social coviewing from T3 to T10.78 score on a scaleStandard Error 0.91
Comparison: Difference on difference for social coviewing from T2 to T1p-value: 0.53ANOVA
Comparison: Difference on difference for social coviewing from T3 to T1p-value: 0.77ANOVA
Other Pre-specified

Child Disruptive Behaviors (Parent Report)

Eyberg Child Behavior Inventory (ECBI); intensity t-score. Higher t-scores indicate poorer outcomes (i.e., greater intensity of behavior problems). T-scores have a mean of 50 (SD = 10). T-scores of 60 or higher indicate clinical significance.

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthChild Disruptive Behaviors (Parent Report)Change in ECBI intensity t-score from T2 to T1-8.95 T-scoreStandard Error 1.25
PCIT-HealthChild Disruptive Behaviors (Parent Report)Change in ECBI intensity t-score from T3 to T1-8.74 T-scoreStandard Error 1.4
Wait List ControlChild Disruptive Behaviors (Parent Report)Change in ECBI intensity t-score from T2 to T10.55 T-scoreStandard Error 1.77
Wait List ControlChild Disruptive Behaviors (Parent Report)Change in ECBI intensity t-score from T3 to T1-1.11 T-scoreStandard Error 2.04
Comparison: Difference on difference for ECBI intensity t-scores from T2 to T1p-value: 0ANOVA
Comparison: Difference on difference for ECBI intensity t-scores from T3 to T1p-value: 0.01ANOVA
Other Pre-specified

Child Psychological Functioning (Parent Report)

Behavior Assessment System for Children (BASC-3); internalizing symptoms t-score (lower scores better outcome) and adaptive skills t-score (higher scores better outcome). T-scores M = 50, SD = 10, with clinical cut-offs at 70 or above.

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthChild Psychological Functioning (Parent Report)Change in internalizing symptoms from T2 to T1-9.48 T-scoreStandard Error 1.54
PCIT-HealthChild Psychological Functioning (Parent Report)Change in internalizing symptoms from T3 to T1-8.58 T-scoreStandard Error 2.02
PCIT-HealthChild Psychological Functioning (Parent Report)Change in adaptive skills from T2 to T1-10.2 T-scoreStandard Error 4.12
PCIT-HealthChild Psychological Functioning (Parent Report)Change in adaptive skills from T3 to T1-13.79 T-scoreStandard Error 5.01
Wait List ControlChild Psychological Functioning (Parent Report)Change in adaptive skills from T3 to T1-10.22 T-scoreStandard Error 7.27
Wait List ControlChild Psychological Functioning (Parent Report)Change in internalizing symptoms from T2 to T1-2.55 T-scoreStandard Error 2.13
Wait List ControlChild Psychological Functioning (Parent Report)Change in adaptive skills from T2 to T1-3.73 T-scoreStandard Error 5.56
Wait List ControlChild Psychological Functioning (Parent Report)Change in internalizing symptoms from T3 to T1-2.00 T-scoreStandard Error 2.93
Comparison: Difference on difference for internalizing symptoms from T2 to T1p-value: 0.02ANOVA
Comparison: Difference on difference for internalizing symptoms from T3 to T1p-value: 0.08ANOVA
Comparison: Difference on difference for adaptive skills from T2 to T1p-value: 0.36ANOVA
Comparison: Difference on difference for adaptive skills from T3 to T1p-value: 0.69ANOVA
Other Pre-specified

Child Psychosocial Strengths (Parent Report)

Psychosocial Strengths Inventory for Children and Adolescents (PSICA). Scores reflect total sum, ranging from 36 (min) to 252 (max); higher scores indicate better outcomes.

Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)

Population: Note that the n and means/sd reflect multiple caregivers per family. Statistical analysis accounts for nested data.

ArmMeasureGroupValue (MEAN)Dispersion
PCIT-HealthChild Psychosocial Strengths (Parent Report)Change in PSICA intensity from T2 to T130.39 score on a scaleStandard Error 4.16
PCIT-HealthChild Psychosocial Strengths (Parent Report)Change in PSICA intensity from T3 to T128.12 score on a scaleStandard Error 4.33
Wait List ControlChild Psychosocial Strengths (Parent Report)Change in PSICA intensity from T2 to T1-5.39 score on a scaleStandard Error 5.89
Wait List ControlChild Psychosocial Strengths (Parent Report)Change in PSICA intensity from T3 to T16.35 score on a scaleStandard Error 6.29
Comparison: Difference on difference for PSICA intensity scores from T2 to T1 (higher scores indicate better outcomes).p-value: 0ANOVA
Comparison: Difference on difference for PSICA intensity scores from T3 to T1p-value: 0.01ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026