An interventional study of PCIT-Health in Child Obesity, sponsored by Central Michigan University. Completed at 1 site in United States. Open to participants aged 30 Months to 84 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by Central Michigan University · Not applicable, Interventional, and Prevention
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.
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This study's enrollment of 63 is below the median of 103 across 869 interventional studies indexed under Pediatric Obesity.
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Exclusion Criteria:
Participants assigned to the PCIT-Health arm will receive the intervention.
Behavioral: PCIT-Health
Participants in the wait list control will receive an invitation to participate in the intervention 10 months after baseline data collection.
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).
Also known as: PATCH Program
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
| Milestone | PCIT-Health | Wait List Control |
|---|---|---|
| Started | 41 | 18 |
| Completed | 30 | 15 |
| Not completed | 11 | 3 |
Change in child BMI percentile will be calculated using standardized anthropometric measurement (height and weight) procedure
| percentile | PCIT-Health | Wait List Control |
|---|---|---|
| Change in BMI percentile (T2-T1); negative values indicate decrease in BMI percentile | 3.66 ± 2.29 | 1.74 ± 3.24 |
| Change in BMI percentile (T3-T1); negative values indicate decrease in BMI percentile | 1.12 ± 2.56 | 0.88 ± 3.72 |
Emotion Regulation (ER) Checklist, higher scores = greater regulation (better outcome). Mean calculation for total score, with Min=1 to Max=4
| units on a scale | PCIT-Health | Wait List Control |
|---|---|---|
| Change from T2 to T1 on ER subscale | 0.23 ± 0.31 | 0.03 ± 0.38 |
| Change from T3 to T1 on ER subscale | 0.26 ± 0.29 | 0.26 ± 0.42 |
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.
| Hours per week | PCIT-Health | Wait List Control |
|---|---|---|
| Change in weekly screen time from T2 to T1 | -5.72 ± 12.52 | 0.36 ± 18.37 |
| Change in weekly screen time from T3 to T1 | -2.92 ± 12.08 | -8.75 ± 26.62 |
Measured by Actigraph accelerometer to assess sedentary, moderate, moderate-to-vigorous, and vigorous physical activity (MVPA)
| minutes | PCIT-Health | Wait List Control |
|---|---|---|
| Change in Moderate-Vigorous Physical Activity minutes from T2 to T1 (higher scores = more activity) | 38.26 ± 13.78 | 2.94 ± 19.48 |
| Change in Moderate-Vigorous Physical Activity minutes from T3 to T1 (higher scores = more activity) | 32.55 ± 18.40 | 16.46 ± 24.09 |
| Change in Sedentary minutes from T2 to T1 (higher scores = less activity) | -59.17 ± 31.46 | 5.23 ± 44.50 |
| Change in Sedentary minutes from T3 to T1 (higher scores = less activity) | 14.59 ± 40.32 | -51.65 ± 52.79 |
Measured by parent report of bedtime, wake time, and naps.
| hours | PCIT-Health | Wait List Control |
|---|---|---|
| Change in hours of sleep from T2 to T1 | -1.0 ± 2.25 | -0.36 ± 1.50 |
| Change in hours of sleep from T3 to T1 | -1.05 ± 2.68 | -2.44 ± 1.33 |
Measured by Actigraph accelerometer.
| hours | PCIT-Health | Wait List Control |
|---|---|---|
| Change in minutes of sleep from T2 to T1 | -10.15 ± 8.19 | 2.47 ± 12.38 |
| Change in minutes of sleep from T3 to T1 | -29.54 ± 10.10 | 9.29 ± 13.22 |
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.
| units on a scale | PCIT-Health | Wait List Control |
|---|---|---|
| Change in problematic media use from T2 to T1 | -0.30 ± 0.15 | -0.38 ± 0.21 |
| Change in problematic media use from T3 to T1 | -0.36 ± 0.16 | -0.15 ± 0.23 |
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).
| Skills | PCIT-Health | Wait List Control |
|---|---|---|
| Change in child-centered skills from T2 to T1 | 7.65 ± 1.57 | 0.00 ± 2.12 |
| Change in child-centered skills from T3 to T1 | 6.35 ± 1.99 | -0.11 ± 2.73 |
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.
| score on a scale | PCIT-Health | Wait List Control |
|---|---|---|
| Change in PCDI from T2 to T1 | -9.59 ± 4.00 | 7.64 ± 5.66 |
| Change in PCDI from T3 to T1 | -13.21 ± 3.63 | 6.22 ± 5.27 |
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).
| score on a scale | PCIT-Health | Wait List Control |
|---|---|---|
| Change in pressure to eat scores from T2 to T1 | -0.84 ± 0.21 | -0.59 ± 0.29 |
| Change in pressure to eat scores from T3 to T1 | -0.59 ± 0.21 | -0.58 ± 0.31 |
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).
| score on a scale | PCIT-Health | Wait List Control |
|---|---|---|
| Change in Restriction scores from T2 to T1 | -0.71 ± 0.18 | -0.25 ± 0.26 |
| Change in Restriction scores from T3 to T1 | -0.88 ± 0.20 | -0.53 ± 0.29 |
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.
| score on a scale | PCIT-Health | Wait List Control |
|---|---|---|
| Change in emotional feeding from T2 to T1 | -0.19 ± 0.13 | -0.16 ± 0.19 |
| Change in emotional feeding from T3 to T1 | -0.37 ± 0.12 | -0.20 ± 0.18 |
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.
| score on a scale | PCIT-Health | Wait List Control |
|---|---|---|
| Change in instrumental feeding from T2 to T1 | -0.74 ± 0.12 | -0.27 ± 0.16 |
| Change in instrumental feeding from T3 to T1 | -0.91 ± 0.13 | -0.36 ± 0.19 |
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.
| score on a scale | PCIT-Health | Wait List Control |
|---|---|---|
| Change in active mediation from T2 to T1 | 2.86 ± 0.61 | 0.64 ± 0.86 |
| Change in active mediation from T3 to T1 | 2.95 ± 0.84 | 0.44 ± 1.21 |
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.
| score on a scale | PCIT-Health | Wait List Control |
|---|---|---|
| Change in restrictive mediation from T2 to T1 | 2.36 ± 0.57 | -1.27 ± 0.81 |
| Change in restrictive mediation from T3 to T1 | 1.53 ± 0.61 | 0.22 ± 0.89 |
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.
| score on a scale | PCIT-Health | Wait List Control |
|---|---|---|
| Change in social coviewing from T2 to T1 | 1.14 ± 0.61 | 0.45 ± 0.86 |
| Change in social coviewing from T3 to T1 | 1.11 ± 0.63 | 0.78 ± 0.91 |
Parents will report on the location/quantity of screen media in home and child's bedroom.
| number of screens | PCIT-Health | Wait List Control |
|---|---|---|
| Change in number of screens in the home from T2 to T1 | 0.32 ± 0.89 | 0.18 ± 1.18 |
| Change in number of screens in the home from T3 to T1 | 0.49 ± 0.94 | -0.39 ± 1.30 |
| Change in number of screens in the child's bedroom from T2 to T1 | -0.21 ± 0.22 | 0.19 ± 0.30 |
| Change in number of screens in the child's bedroom from T3 to T1 | -0.58 ± 0.22 | 0.33 ± 0.32 |
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).
| score on a scale | PCIT-Health | Wait List Control |
|---|---|---|
| Change in TV on during mealtime from T2 to T1 | -0.39 ± 0.11 | 0.11 ± 0.18 |
| Change in TV on during mealtime from T3 to T1 | -0.33 ± 0.10 | 0.00 ± 0.16 |
| Change in mobile device present during mealtime from T2 to T1 | -0.09 ± 0.12 | 0.11 ± 0.20 |
| Change in mobile device present during mealtime from T3 to T1 | 0.00 ± 0.11 | 0.29 ± 0.18 |
| Change in other media present during mealtime from T2 to T1 | -0.17 ± 0.08 | 0.22 ± 0.13 |
| Change in other media present during mealtime from T3 to T1 | -0.22 ± 0.09 | 0.0 ± 0.14 |
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.
| score on a scale | PCIT-Health | Wait List Control |
|---|---|---|
| Change in TA score during mealtime from T2 to T1 | 0.09 ± 0.07 | -0.33 ± 0.12 |
| Change in TA score during mealtime from T3 to T1 | 0.11 ± 0.08 | 0.14 ± 0.13 |
| Change in BC score during mealtime from T2 to T1 | 0.13 ± 0.10 | -0.11 ± 0.17 |
| Change in BC score during mealtime from T3 to T1 | 0.11 ± 0.08 | 0.14 ± 0.13 |
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.
| T-score | PCIT-Health | Wait List Control |
|---|---|---|
| Change in ECBI intensity t-score from T2 to T1 | -8.95 ± 1.25 | 0.55 ± 1.77 |
| Change in ECBI intensity t-score from T3 to T1 | -8.74 ± 1.40 | -1.11 ± 2.04 |
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.
| T-score | PCIT-Health | Wait List Control |
|---|---|---|
| Change in internalizing symptoms from T2 to T1 | -9.48 ± 1.54 | -2.55 ± 2.13 |
| Change in internalizing symptoms from T3 to T1 | -8.58 ± 2.02 | -2.00 ± 2.93 |
| Change in adaptive skills from T2 to T1 | -10.2 ± 4.12 | -3.73 ± 5.56 |
| Change in adaptive skills from T3 to T1 | -13.79 ± 5.01 | -10.22 ± 7.27 |
Psychosocial Strengths Inventory for Children and Adolescents (PSICA). Scores reflect total sum, ranging from 36 (min) to 252 (max); higher scores indicate better outcomes.
| score on a scale | PCIT-Health | Wait List Control |
|---|---|---|
| Change in PSICA intensity from T2 to T1 | 30.39 ± 4.16 | -5.39 ± 5.89 |
| Change in PSICA intensity from T3 to T1 | 28.12 ± 4.33 | 6.35 ± 6.29 |
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.
| Z-score | PCIT-Health | Wait List Control |
|---|---|---|
| Change in BMI z-score (T2-T1); negative values indicate decrease in BMI z-score | 0.11 ± 0.08 | 0.06 ± 0.12 |
| Change in BMI z-score (T3-T1); negative values indicate decrease in BMI z-score | 0.01 ± 0.10 | 0.02 ± 0.15 |
Collected over During of the study (approximately 10 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PCIT-Health | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
| Wait List Control | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Age, Categorical(Participants) | PCIT-Health | Wait List Control | Total |
|---|---|---|---|
| Child — <=18 years | 14 | 7 | 21 |
| Child — Between 18 and 65 years | 0 | 0 | 0 |
| Child — >=65 years | 0 | 0 | 0 |
| Caregiver — <=18 years | 0 | 0 | 0 |
| Caregiver — Between 18 and 65 years | 27 | 11 | 38 |
| Caregiver — >=65 years | 0 | 0 | 0 |
| Age, Continuous(months) | PCIT-Health | Wait List Control | Total |
|---|---|---|---|
| Mean | 53.36 ± 16.06 | 50.86 ± 11.95 | 52.52 ± 14.56 |
| Sex: Female, Male(Participants) | PCIT-Health | Wait List Control | Total |
|---|---|---|---|
| Child — Female | 5 | 3 | 8 |
| Child — Male | 9 | 4 | 13 |
| Caregiver — Female | 16 | 8 | 24 |
| Caregiver — Male | 11 | 3 | 14 |
| Ethnicity (NIH/OMB)(Participants) | PCIT-Health | Wait List Control | Total |
|---|---|---|---|
| Child — Hispanic or Latino | 1 | 2 | 3 |
| Child — Not Hispanic or Latino | 13 | 5 | 18 |
| Child — Unknown or Not Reported | 0 | 0 | 0 |
| Caregiver — Hispanic or Latino | 1 | 1 | 2 |
| Caregiver — Not Hispanic or Latino | 26 | 10 | 36 |
| Caregiver — Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | PCIT-Health | Wait List Control | Total |
|---|---|---|---|
| Child — American Indian or Alaska Native | 0 | 0 | 0 |
| Child — Asian | 1 | 0 | 1 |
| Child — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Child — Black or African American | 0 | 0 | 0 |
| Child — White | 12 | 5 | 17 |
| Child — More than one race | 1 | 2 | 3 |
| Child — Unknown or Not Reported | 0 | 0 | 0 |
| Caregiver — American Indian or Alaska Native | 0 | 0 | 0 |
| Caregiver — Asian | 2 | 0 | 2 |
| Caregiver — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Caregiver — Black or African American | 2 | 0 | 2 |
| Caregiver — White | 23 | 11 | 34 |
| Caregiver — More than one race | 0 | 0 | 0 |
| Caregiver — Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | PCIT-Health | Wait List Control | Total |
|---|---|---|---|
| United States | 41 | 18 | 59 |
| Body Mass Index (BMI) z-score(Z-score) | PCIT-Health | Wait List Control | Total |
|---|---|---|---|
| Mean | 0.71 ± 1.21 | 0.77 ± 0.84 | 0.73 ± 1.08 |
| BMI percentile(percentile) | PCIT-Health | Wait List Control | Total |
|---|---|---|---|
| Mean | 68.09 ± 30.50 | 73.94 ± 26.52 | 70.04 ± 28.70 |
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