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Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers (KEEP-P)

Randomized Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03106636
Acronym
KEEP-P
Enrollment
442
Registered
2017-04-10
Start date
2014-05-20
Completion date
2018-10-01
Last updated
2020-07-14

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

Conditions

Child Behavior

Keywords

Preschool-aged, Foster children, child welfare, Fostercare, Parent training, early adversity, curriculum based, early intervention, preschool, foster placement disruptions, manualized intervention, group based intervention, high-risk children

Brief summary

Randomized Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers (KEEP-P). The goal of the proposed study is to conduct a randomized clinical trial of a new, low-cost, manualized, group-based intervention for preschoolers and their caregivers. The investigators will examine the extent to which the two intervention conditions show improved parenting, reduced rates of disrupted placements, and improved child outcomes.

Detailed description

Randomized Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers (KEEP-P). Preschool-aged foster and other high-risk children are at increased risk for numerous negative outcomes. However, there is very limited use of evidence-based interventions for these young children. Major barriers to progress in this area include a lack of available evidence-based programs for high-risk children across the preschool years and the tendency for the few existing evidence-based interventions to be resource intensive in terms of funding and the level of staff expertise required to be implemented with fidelity. Readily scalable, evidence-based interventions for foster and other high-risk preschoolers are clearly needed to reduce the widespread disparities. The goal of the proposed study is to conduct a randomized clinical trial of a new, low-cost, manualized, group-based intervention for caregivers of preschool aged children. The investigators propose to evaluate two versions of the intervention: (a) a basic version that employs a curriculum consisting of 12 weekly psychoeducational caregiver support groups and (b) an augmented version that consists of the caregiver support groups with extended curriculum including with the addition of information about recent findings in early brain development and the elements of the Filming Interactions to Nurture Development (FIND) video coaching program. Across four waves of data collection (baseline, immediately postintervention, and 12 and 18 months postbaseline), the investigators will examine the extent to which the two intervention conditions show improved parenting, reduced rates of disrupted placements, and improved child outcomes. The investigators will conduct multivariate modeling to examine mediating mechanisms underlying the hypothesized immediate and longer- term intervention effects. Finally, the investigators will conduct a comprehensive economic evaluation to examine the incremental costs associated with implementing the intervention and the benefits realized in the intervention conditions in terms of increased positive outcomes for children.

Interventions

BEHAVIORALKEEP-P

The KEEP-P program is a low-cost, manualized, group-based intervention for caregivers of preschool aged children. This trial is evaluating 2 versions of the intervention. KEEP-P is a basic version that employs a curriculum of 12 weekly psychoeducational caregiver support groups Across four waves of data collection (baseline, post-intervention, and 12 and 18 months post-baseline), we will examine the extent to which this intervention condition shows improved parenting, reduced rates of disrupted placements, and improved child outcomes.

BEHAVIORALKEEP-P+

The KEEP-P program is a low-cost, manualized, group-based intervention for caregivers of preschool aged children. This trial is evaluating 2 versions of the intervention. KEEP-P+ is an augmented version that consists of the caregiver support groups with extended curriculum including information about recent findings in early brain development and the elements of the Filming Interactions to Nurture Development video coaching program. Across four waves of data collection (baseline, post-intervention, and 12 and 18 months post-baseline), we will examine the extent to which this intervention condition show improved parenting, reduced rates of disrupted placements, and improved child outcomes.

Sponsors

Oregon Social Learning Center
CollaboratorOTHER
University of Oregon
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
ALL
Age
30 Months to 6 Years
Healthy volunteers
Yes

Inclusion criteria

* Preschool-aged foster children * Preschool-aged children referred to early intervention/childhood special education services

Exclusion criteria

* Children will be excluded from recruitment if they or their primary caregiver are not sufficiently fluent in English to complete the assessment or if it is determined that the child would not be able to complete the assessment procedures due to a severe developmental, medical, or physical disorder.

Design outcomes

Primary

MeasureTime frameDescription
Parenting Stress Via Self-report Measure Parenting Stress Index IV (PSI-IV) Short FormChange from baseline at endpoint (3-4 months post-baseline)The Parenting Stress Index IV (PSI-IV) Short Form evaluates the magnitude of stress in the parent-child relationship based on the parent's perception of the child's characteristics, the personal characteristics of the parent, and the interaction between the parent and child. It is a 5-point Likert scale ranging from strongly agree to strongly disagree with 36 items. Item 32 is the only item which is reverse coded. For all the other items, higher scores indicate higher levels of stress. Total parenting stress score is calculated by summing up scores of all the 36 items, ranging from 36 to 180.
Caregiver's Perceived Sense of Competency in Parenting Via Self-report Measure Parent Sense of Competency Scale (PSOC)Change from baseline at endpoint (3-4 months post-baseline)The FOI-adapted Parenting Sense of Competence (PSOC) questionnaire is filled out by the caregiver to assess parents' sense of competence and enjoyment of parenting. This is an adapted version of the PSOC (original PSOC has 17 items, Johnston & Mash, 1989), with 18 items and simplified language for lower reading levels. Items are answered on a 4-point Likert scale ranging from strongly agree to strongly disagree. Nine items (#s 2,3,4,5,8,9,13,15 and 17) are reverse coded so that, for all items, higher scores indicate greater parenting self-esteem. Total score of parent's perceived sense of competency is calculated by summing up scores of all the 18 items, ranging from 18 to 72.
Observed Level of Developmentally-supportive Parenting Via Observational Measure Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)Change from baseline at endpoint (3-4 months post-baseline)The Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO) is an observational measure which rates developmentally-supportive parenting across four domains: affection, responsiveness, encouragement, and teaching. It is a checklist of 29 items reflecting positive parent-child interaction behaviors. Each behavior is rated according to their frequency as 0 (absent, no behavior observed), 1 (barely, minor or emerging behavior) and 2 (clearly, definitive, strong and frequent behavior). Higher scores indicating higher levels of positive parenting. PICCOLO total score is calculated by summing up scores of all the 29 items, ranging from 0 to 58.
Frequency of Family Routines Via Self-report Measure Family Routines Questionnaire (FRQ)Change from baseline at endpoint (3-4 months post-baseline)The Family Routines Questionnaire (FRQ) is a 28-item measure of the frequency and rated importance of family routines. Scores are calculated based on the how frequent the family's routines are and how important the routines are to them. The frequency of family routines construct was reported in the results. To rate each endorsed routine by the frequency of its performance by the family, daily performance is assigned a weight of 3, a somewhat less frequency performance of 3-5 times a week is assigned a weight of 2; and an even less frequent performance of l-2 times a week is assigned a weight of 1. The 'almost never' category is taken to mean that the family does not participate in the particular routine, and it is therefore assigned a value of 0 in computing the total inventory score. By summing up frequency scores of all the 28 items, the total frequency score ranges from 0 to 84. Higher scores indicate higher frequency of family routines.
Mindful Parenting Via Self-report Measure Interpersonal Mindfulness in Parenting (IEMP)Change from baseline at endpoint (3-4 months post-baseline)The Interpersonal Mindfulness in Parenting (IEMP) scale is a 10-item measure to investigate the quality of interpersonal mindfulness in parenting. Items are answered on a 5-point Likert scale ranging from never true to always true. Four items (#s 1,5,9, and 10) are reverse coded. Total score is the sum of all the item scores, ranging from 10 to 50. Higher scores indicate higher quality of Mindful parenting.
Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)Change from baseline at endpoint (3-4 months post-baseline)The Attachment Diary (ADRY) is a 47-item measure in which caregivers report how the child reacts when hurt, frightened, or separated from the caregiver by placing check marks on a behavior list. All the checked behaviors are coded into three categories, proximity seeking/contact maintenance, avoidance, and resistance, to assess individual differences in child's attachment behaviors. Thus, there are no total scores for the ADRY, only subscale scores for the three categories. Outcomes include scores for proximity seeking/contact maintenance (range from 0 to 14), scores for avoidance (range from 0 to 18), and scores for resistance (range from 0 to 6), which are generated by counting the number of checked behaviors in corresponding subscales. Higher scores indicate higher levels of behaviors correspondingly.
Child Internalizing/Externalizing Symptoms and Total Behavior Score Via Caregiver-report Measure Child Behaviour Checklist (CBCL)Change from baseline at endpoint (3-4 months post-baseline)The Child Behavior Checklist (CBCL) is a 100-item questionnaire to assess emotional and behavioral problems in children. Caregivers are asked to rate how often their child displayed certain behaviors in the past two months on a 3-point Likert scale (0 = Not True, 1 = Somewhat/Sometimes True, 2 = Very True/Often True). Subscales include: Internalizing symptoms - Emotionally Reactive: 21, 46, 82, 83, 92, 97, 99; Anxious/Depressed: 10, 33, 37, 43, 47, 68, 87, 90; Somatic Complaints: 1, 7, 39, 45, 78, 86, 93; Withdrawn: 2, 4, 12, 19, 23, 62, 67, 70, 71, 98 Externalizing symptoms - Attention Problems: 5, 6, 24, 48, 51, 56, 59, 64, 95; Aggressive Behavior: 8, 14, 15, 16, 17, 18, 20, 22, 27, 28, 29, 35, 40, 42, 44, 53, 58, 66, 69, 74, 81, 84, 85, 88, 96 Raw scores for each subscale were calculated by summing up item scores correspondingly and then normalized to T-scores. The means are anchored to 50, with a standard deviation of 10 points. Higher T score indicates more behavior problems.
Preschool and Kindergarten Behavior Scales (PKBS)Change from baseline at endpoint (3-4 months post-baseline)Caregivers perception of their child's behaviors via the Preschool and Kindergarten Behavior Scales (PKBS). Items are on a 4-point scale ranging from never to often. Higher scores indicate more behavior problems. PKBS total score (76 items) sum score ranging between 0-228.
Parental Stress Via Caregiver-report Measure Parent Daily Report (PDR)Change from baseline at endpoint (3-4 months post-baseline)The Parent Daily Report (PDR) is a caregiver-report measure assessing child behaviour problems and associated parental stress occurring in the past 24 hours. The measure has several versions. The version used in the present research is the Oregon Social Learning Center Community Programs PDR which has 39 questions with only negative child behaviors, targeting to children from 3 to 6 years. Caregivers rate each child behavior as 0 = Did Not Occur, 1 = Occurred & Not Stressful, 2 = Occurred & Stressful. The PDR was administered 3 times per wave. For each response, total score of stressful behaviors was calculated by counting the number of behaviors rated as 2 = Occurred & Stressful. Then the three total scores was averaged to get the mean of stressful behaviors (ranges from 0 to 39) as a indicator of parental stress. Higher score indicates higher level of parental stress.
Child Social-emotional Development Via Caregiver-report Measure Ages and Stages Questionnaire: Social-Emotional (ASQ:SE)Change from baseline at endpoint (3-4 months post-baseline)The Ages and Stages Questionnaires: Social-Emotional Development Screening Tool (ASQ:SE) is a caregiver-report questionnaire about children's social-emotional development. The ASQ:SE has 29 questions, of which 26 questions are scored from 0-15, the others are open-ended. Therefore the total score (the sum of the 26 item scores) ranges from 0 to 390. Lower scores indicate more pocitive outcomes, i.e. better social-emotional development.
Observed Level of Child Inhibitory Control Via Delay Choice ParadigmChange from baseline at endpoint (3-4 months post-baseline)In the Delay Choice Paradigm, children were asked to make choices between getting one penny/sticker/treat now or four (or more) to bring home for nine times. Total score is the total times when the child chooses the bring home option (ranges from 0 to 9). Higher score indicates better ability for child to delay gratification, i.e. better inhibitory control.
Dimensional Change Card Sort (DCCS)Change from baseline at endpoint (3-4 months post-baseline)The total number of phases passed in the DCCS. A phase was passed if 4/6 trials were correct. Children only proceeded to the next phase if they passed the previous phase. 5 phases total. Higher score indicates better executive functioning.
Observed Level of Child Inhibitory Control Via Bear/Dragon TaskChange from baseline at endpoint (3-4 months post-baseline)In the Bear/Dragon Task, children were presented with a nice bear and a mean dragon and instructed to do what the bear says (e.g., touch your nose), but not to do what the dragon says. Children's compliance was scored on a 4-point scale on 5 bear trials (0 = failure to move; 1 = a wrong movement; 2 = a partial movement; 3 = a full correct movement) and 5 dragon trials (0 = a full commanded movement; 1 = a partial commanded movement; 2 = a flinch or wrong movement; 3 = no movement). Scores of each trial are summed up to produce a total score ranging from 0 to 30. A higher score indicates better inhibitory control.
Observed Level of Child Working Memory Via Spin the Pots TaskChange from baseline at endpoint (3-4 months post-baseline)In the Spin the Pots Task, several visually distinct boxes were arranged on a rotating tray (2.5-year -olds: 8 boxes; 3-year-olds: 9 boxes; 3.5 year olds: 10 boxes; 4-year-olds; 11 boxes). Children watched the experimenter hide colourful stickers inside all but two boxes, cover the boxes with a cloth, and rotate a tray for a few seconds to mark the beginning of a search trial. The cloth was removed and children were instructed to select a box to find a sticker. If a sticker was found, children were allowed to keep it. After each search attempt, the tray was covered and rotated again to mark the beginning of the next search trial. The task was completed once children found all hidden stickers or after the allotted number of trials (2.5-year -olds: 12 trials; 3-year-olds: 14 trials; 3.5 year olds: 16 trials; 4-year-olds; 18 trials). Ratio of stickers found to number of trials ranges from 0 to 1. A higher score indicates better working memory.
Silly Animal CategoriesChange from baseline at endpoint (3-4 months post-baseline)Proportion of animals sorted correctly after rule switch. Higher score indicates better executive functioning.
Child Executive Function Via Kansas Reflection-Impulsivity Scale for Preschoolers (KRISP)Change from baseline at endpoint (3-4 months post-baseline)The Kansas Reflection-Impulsivity Scale for Preschoolers (KRISP) presents children with a target picture and 4-6 similar pictures. Children were asked to identify an exact match of the target picture. Fifteen test trials were administered following a single practice trial. Each item was scored based on the number of incorrect responses, up to 3 errors. Final score is calculated as the number of errors subtracted from the total errors possible (45), ranging from 0 to 45. Higher score indicates better executive functioning.

Countries

United States

Participant flow

Recruitment details

Numbers reported are number of participants (caregivers and their children). The Protocol Enrollment number (442) differs from the number of participants in the Started category (416) due to a control group condition (services as usual) being removed from the study early on. 416 started in the two study conditions (KEEP-P and KEEP-P+)

Participants by arm

ArmCount
KEEP-P
The KEEP-P caregiver support groups employ a manualized 12-session, weekly curriculum for foster, kinship, and biological caregivers. Each weekly 2 hour session is structured so that the curriculum content is integrated into group discussions, and primary concepts are illustrated via role-play. Home practice assignments are given weekly and relate to the topics covered during sessions to assist parents in implementing the behavioral procedures taught.
226
KEEP-P+
The KEEP-P+ group received the same 12-session, weekly curriculum as the KEEP-P group, and also received an additional video coaching component. The video coaching employs video of caregivers' natural interactions with their child to show ways that they are supporting children's healthy development. It is a simple and practical approach that emphasizes caregivers' strengths and capabilities. It begins with video recordings of a caregiver and child in their home or other natural setting. The film is carefully edited to show brief clips in which the caregiver is engaged in developmentally supportive interactions with the child. At a group coaching session, a coach reviews the edited clips in detail with the caregivers.
190
Total416

Baseline characteristics

CharacteristicKEEP-PKEEP-P+Total
Age, Categorical
<=18 years
107 Participants90 Participants197 Participants
Age, Categorical
>=65 years
8 Participants1 Participants9 Participants
Age, Categorical
Between 18 and 65 years
101 Participants90 Participants191 Participants
Age, Continuous
Caregivers
48.62 years
STANDARD_DEVIATION 11.355
45.86 years
STANDARD_DEVIATION 9.63
47.37 years
STANDARD_DEVIATION 10.669
Age, Continuous
Children
2.61 years
STANDARD_DEVIATION 0.888
2.32 years
STANDARD_DEVIATION 0.633
2.48 years
STANDARD_DEVIATION 0.793
Ethnicity (NIH/OMB)
Hispanic or Latino
13 Participants27 Participants40 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
169 Participants155 Participants324 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
44 Participants8 Participants52 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants2 Participants4 Participants
Race (NIH/OMB)
Asian
7 Participants0 Participants7 Participants
Race (NIH/OMB)
Black or African American
3 Participants1 Participants4 Participants
Race (NIH/OMB)
More than one race
40 Participants39 Participants79 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
48 Participants16 Participants64 Participants
Race (NIH/OMB)
White
126 Participants131 Participants257 Participants
Region of Enrollment
United States
226 participants190 participants416 participants
Sex: Female, Male
Female
126 Participants114 Participants240 Participants
Sex: Female, Male
Male
91 Participants67 Participants158 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2260 / 190
other
Total, other adverse events
0 / 2260 / 190
serious
Total, serious adverse events
0 / 2260 / 190

Outcome results

Primary

Caregiver's Perceived Sense of Competency in Parenting Via Self-report Measure Parent Sense of Competency Scale (PSOC)

The FOI-adapted Parenting Sense of Competence (PSOC) questionnaire is filled out by the caregiver to assess parents' sense of competence and enjoyment of parenting. This is an adapted version of the PSOC (original PSOC has 17 items, Johnston & Mash, 1989), with 18 items and simplified language for lower reading levels. Items are answered on a 4-point Likert scale ranging from strongly agree to strongly disagree. Nine items (#s 2,3,4,5,8,9,13,15 and 17) are reverse coded so that, for all items, higher scores indicate greater parenting self-esteem. Total score of parent's perceived sense of competency is calculated by summing up scores of all the 18 items, ranging from 18 to 72.

Time frame: Change from baseline at endpoint (3-4 months post-baseline)

Population: The number analyzed in the endpoint and change rows is different from the baseline row because we were not able to retain every participant for the post-intervention data collection.

ArmMeasureGroupValue (MEAN)Dispersion
KEEP-PCaregiver's Perceived Sense of Competency in Parenting Via Self-report Measure Parent Sense of Competency Scale (PSOC)Baseline49.42 score on a scaleStandard Deviation 5.18
KEEP-PCaregiver's Perceived Sense of Competency in Parenting Via Self-report Measure Parent Sense of Competency Scale (PSOC)Endpoint51.6 score on a scaleStandard Deviation 5.46
KEEP-PCaregiver's Perceived Sense of Competency in Parenting Via Self-report Measure Parent Sense of Competency Scale (PSOC)Change2.14 score on a scaleStandard Deviation 3.39
KEEP-P+Caregiver's Perceived Sense of Competency in Parenting Via Self-report Measure Parent Sense of Competency Scale (PSOC)Baseline49.82 score on a scaleStandard Deviation 6.33
KEEP-P+Caregiver's Perceived Sense of Competency in Parenting Via Self-report Measure Parent Sense of Competency Scale (PSOC)Endpoint50.15 score on a scaleStandard Deviation 5.22
KEEP-P+Caregiver's Perceived Sense of Competency in Parenting Via Self-report Measure Parent Sense of Competency Scale (PSOC)Change0.3 score on a scaleStandard Deviation 4.84
Primary

Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)

The Attachment Diary (ADRY) is a 47-item measure in which caregivers report how the child reacts when hurt, frightened, or separated from the caregiver by placing check marks on a behavior list. All the checked behaviors are coded into three categories, proximity seeking/contact maintenance, avoidance, and resistance, to assess individual differences in child's attachment behaviors. Thus, there are no total scores for the ADRY, only subscale scores for the three categories. Outcomes include scores for proximity seeking/contact maintenance (range from 0 to 14), scores for avoidance (range from 0 to 18), and scores for resistance (range from 0 to 6), which are generated by counting the number of checked behaviors in corresponding subscales. Higher scores indicate higher levels of behaviors correspondingly.

Time frame: Change from baseline at endpoint (3-4 months post-baseline)

Population: The number analyzed in the endpoint and change rows is different from the baseline row because we were not able to retain every participant for the post-intervention data collection.

ArmMeasureGroupValue (MEAN)Dispersion
KEEP-PChild Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)Change Resistance-0.08 score on a scaleStandard Deviation 0.95
KEEP-PChild Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)Endpoint Avoidance1.78 score on a scaleStandard Deviation 2.33
KEEP-PChild Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)Change Avoidance-0.03 score on a scaleStandard Deviation 2.15
KEEP-PChild Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)Baseline Proximity7.53 score on a scaleStandard Deviation 3.89
KEEP-PChild Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)Endpoint Proximity7.75 score on a scaleStandard Deviation 3.83
KEEP-PChild Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)Change Proximity0.22 score on a scaleStandard Deviation 3.41
KEEP-PChild Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)Baseline Avoidance1.84 score on a scaleStandard Deviation 2.22
KEEP-PChild Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)Baseline Resistance0.72 score on a scaleStandard Deviation 1.03
KEEP-PChild Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)Endpoint Resistance0.57 score on a scaleStandard Deviation 1.08
KEEP-P+Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)Endpoint Resistance0.70 score on a scaleStandard Deviation 0.99
KEEP-P+Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)Change Resistance-0.21 score on a scaleStandard Deviation 1.1
KEEP-P+Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)Change Proximity-0.49 score on a scaleStandard Deviation 4.17
KEEP-P+Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)Endpoint Avoidance2.06 score on a scaleStandard Deviation 2.53
KEEP-P+Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)Baseline Resistance0.88 score on a scaleStandard Deviation 1.15
KEEP-P+Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)Baseline Avoidance1.95 score on a scaleStandard Deviation 2.19
KEEP-P+Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)Baseline Proximity8.42 score on a scaleStandard Deviation 3.73
KEEP-P+Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)Change Avoidance-0.04 score on a scaleStandard Deviation 2.22
KEEP-P+Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)Endpoint Proximity7.87 score on a scaleStandard Deviation 3.78
Primary

Child Executive Function Via Kansas Reflection-Impulsivity Scale for Preschoolers (KRISP)

The Kansas Reflection-Impulsivity Scale for Preschoolers (KRISP) presents children with a target picture and 4-6 similar pictures. Children were asked to identify an exact match of the target picture. Fifteen test trials were administered following a single practice trial. Each item was scored based on the number of incorrect responses, up to 3 errors. Final score is calculated as the number of errors subtracted from the total errors possible (45), ranging from 0 to 45. Higher score indicates better executive functioning.

Time frame: Change from baseline at endpoint (3-4 months post-baseline)

Population: The number analyzed in the endpoint and change rows is different from the baseline row because we were not able to retain every participant for the post-intervention data collection.

ArmMeasureGroupValue (MEAN)Dispersion
KEEP-PChild Executive Function Via Kansas Reflection-Impulsivity Scale for Preschoolers (KRISP)Baseline35.76 score on a scaleStandard Deviation 7.9
KEEP-PChild Executive Function Via Kansas Reflection-Impulsivity Scale for Preschoolers (KRISP)Endpoint37.81 score on a scaleStandard Deviation 6.23
KEEP-PChild Executive Function Via Kansas Reflection-Impulsivity Scale for Preschoolers (KRISP)Change2.16 score on a scaleStandard Deviation 8.97
KEEP-P+Child Executive Function Via Kansas Reflection-Impulsivity Scale for Preschoolers (KRISP)Baseline33.52 score on a scaleStandard Deviation 7.78
KEEP-P+Child Executive Function Via Kansas Reflection-Impulsivity Scale for Preschoolers (KRISP)Endpoint35.8 score on a scaleStandard Deviation 7.6
KEEP-P+Child Executive Function Via Kansas Reflection-Impulsivity Scale for Preschoolers (KRISP)Change3.96 score on a scaleStandard Deviation 7.55
Primary

Child Internalizing/Externalizing Symptoms and Total Behavior Score Via Caregiver-report Measure Child Behaviour Checklist (CBCL)

The Child Behavior Checklist (CBCL) is a 100-item questionnaire to assess emotional and behavioral problems in children. Caregivers are asked to rate how often their child displayed certain behaviors in the past two months on a 3-point Likert scale (0 = Not True, 1 = Somewhat/Sometimes True, 2 = Very True/Often True). Subscales include: Internalizing symptoms - Emotionally Reactive: 21, 46, 82, 83, 92, 97, 99; Anxious/Depressed: 10, 33, 37, 43, 47, 68, 87, 90; Somatic Complaints: 1, 7, 39, 45, 78, 86, 93; Withdrawn: 2, 4, 12, 19, 23, 62, 67, 70, 71, 98 Externalizing symptoms - Attention Problems: 5, 6, 24, 48, 51, 56, 59, 64, 95; Aggressive Behavior: 8, 14, 15, 16, 17, 18, 20, 22, 27, 28, 29, 35, 40, 42, 44, 53, 58, 66, 69, 74, 81, 84, 85, 88, 96 Raw scores for each subscale were calculated by summing up item scores correspondingly and then normalized to T-scores. The means are anchored to 50, with a standard deviation of 10 points. Higher T score indicates more behavior problems.

Time frame: Change from baseline at endpoint (3-4 months post-baseline)

Population: The number analyzed in the endpoint and change rows is different from the baseline row because we were not able to retain every participant for the post-intervention data collection.

ArmMeasureGroupValue (MEAN)Dispersion
KEEP-PChild Internalizing/Externalizing Symptoms and Total Behavior Score Via Caregiver-report Measure Child Behaviour Checklist (CBCL)Change-3.24 T-scoreStandard Deviation 6.95
KEEP-PChild Internalizing/Externalizing Symptoms and Total Behavior Score Via Caregiver-report Measure Child Behaviour Checklist (CBCL)Baseline59.6 T-scoreStandard Deviation 12.13
KEEP-PChild Internalizing/Externalizing Symptoms and Total Behavior Score Via Caregiver-report Measure Child Behaviour Checklist (CBCL)Endpoint57.18 T-scoreStandard Deviation 12.44
KEEP-P+Child Internalizing/Externalizing Symptoms and Total Behavior Score Via Caregiver-report Measure Child Behaviour Checklist (CBCL)Endpoint57.47 T-scoreStandard Deviation 12.14
KEEP-P+Child Internalizing/Externalizing Symptoms and Total Behavior Score Via Caregiver-report Measure Child Behaviour Checklist (CBCL)Change-3.76 T-scoreStandard Deviation 6.63
KEEP-P+Child Internalizing/Externalizing Symptoms and Total Behavior Score Via Caregiver-report Measure Child Behaviour Checklist (CBCL)Baseline61.65 T-scoreStandard Deviation 11.72
Primary

Child Social-emotional Development Via Caregiver-report Measure Ages and Stages Questionnaire: Social-Emotional (ASQ:SE)

The Ages and Stages Questionnaires: Social-Emotional Development Screening Tool (ASQ:SE) is a caregiver-report questionnaire about children's social-emotional development. The ASQ:SE has 29 questions, of which 26 questions are scored from 0-15, the others are open-ended. Therefore the total score (the sum of the 26 item scores) ranges from 0 to 390. Lower scores indicate more pocitive outcomes, i.e. better social-emotional development.

Time frame: Change from baseline at endpoint (3-4 months post-baseline)

Population: The number analyzed in the endpoint and change rows is different from the baseline row because we were not able to retain every participant for the post-intervention data collection.

ArmMeasureGroupValue (MEAN)Dispersion
KEEP-PChild Social-emotional Development Via Caregiver-report Measure Ages and Stages Questionnaire: Social-Emotional (ASQ:SE)Endpoint105 score on a scaleStandard Deviation 74.47
KEEP-PChild Social-emotional Development Via Caregiver-report Measure Ages and Stages Questionnaire: Social-Emotional (ASQ:SE)Baseline121.35 score on a scaleStandard Deviation 77.58
KEEP-PChild Social-emotional Development Via Caregiver-report Measure Ages and Stages Questionnaire: Social-Emotional (ASQ:SE)Change-14.33 score on a scaleStandard Deviation 33.95
KEEP-P+Child Social-emotional Development Via Caregiver-report Measure Ages and Stages Questionnaire: Social-Emotional (ASQ:SE)Baseline125.81 score on a scaleStandard Deviation 66.21
KEEP-P+Child Social-emotional Development Via Caregiver-report Measure Ages and Stages Questionnaire: Social-Emotional (ASQ:SE)Endpoint119.13 score on a scaleStandard Deviation 71.29
KEEP-P+Child Social-emotional Development Via Caregiver-report Measure Ages and Stages Questionnaire: Social-Emotional (ASQ:SE)Change-2.39 score on a scaleStandard Deviation 42.64
Primary

Dimensional Change Card Sort (DCCS)

The total number of phases passed in the DCCS. A phase was passed if 4/6 trials were correct. Children only proceeded to the next phase if they passed the previous phase. 5 phases total. Higher score indicates better executive functioning.

Time frame: Change from baseline at endpoint (3-4 months post-baseline)

Population: The number analyzed in the endpoint and change rows is different from the baseline row because we were not able to retain every participant for the post-intervention data collection.

ArmMeasureGroupValue (MEAN)Dispersion
KEEP-PDimensional Change Card Sort (DCCS)Baseline1.76 number of phases passedStandard Deviation 1.43
KEEP-PDimensional Change Card Sort (DCCS)Endpoint2.12 number of phases passedStandard Deviation 1.54
KEEP-PDimensional Change Card Sort (DCCS)Change0.48 number of phases passedStandard Deviation 1.29
KEEP-P+Dimensional Change Card Sort (DCCS)Endpoint2.05 number of phases passedStandard Deviation 1.54
KEEP-P+Dimensional Change Card Sort (DCCS)Baseline1.61 number of phases passedStandard Deviation 1.32
KEEP-P+Dimensional Change Card Sort (DCCS)Change0.43 number of phases passedStandard Deviation 1.37
Primary

Frequency of Family Routines Via Self-report Measure Family Routines Questionnaire (FRQ)

The Family Routines Questionnaire (FRQ) is a 28-item measure of the frequency and rated importance of family routines. Scores are calculated based on the how frequent the family's routines are and how important the routines are to them. The frequency of family routines construct was reported in the results. To rate each endorsed routine by the frequency of its performance by the family, daily performance is assigned a weight of 3, a somewhat less frequency performance of 3-5 times a week is assigned a weight of 2; and an even less frequent performance of l-2 times a week is assigned a weight of 1. The 'almost never' category is taken to mean that the family does not participate in the particular routine, and it is therefore assigned a value of 0 in computing the total inventory score. By summing up frequency scores of all the 28 items, the total frequency score ranges from 0 to 84. Higher scores indicate higher frequency of family routines.

Time frame: Change from baseline at endpoint (3-4 months post-baseline)

Population: The number analyzed in the endpoint and change rows is different from the baseline row because we were not able to retain every participant for the post-intervention data collection.

ArmMeasureGroupValue (MEAN)Dispersion
KEEP-PFrequency of Family Routines Via Self-report Measure Family Routines Questionnaire (FRQ)Baseline51.66 score on a scaleStandard Deviation 11.66
KEEP-PFrequency of Family Routines Via Self-report Measure Family Routines Questionnaire (FRQ)Endpoint52.63 score on a scaleStandard Deviation 9.79
KEEP-PFrequency of Family Routines Via Self-report Measure Family Routines Questionnaire (FRQ)Change1.37 score on a scaleStandard Deviation 10.34
KEEP-P+Frequency of Family Routines Via Self-report Measure Family Routines Questionnaire (FRQ)Baseline50.43 score on a scaleStandard Deviation 9
KEEP-P+Frequency of Family Routines Via Self-report Measure Family Routines Questionnaire (FRQ)Endpoint52.09 score on a scaleStandard Deviation 9.32
KEEP-P+Frequency of Family Routines Via Self-report Measure Family Routines Questionnaire (FRQ)Change1.3 score on a scaleStandard Deviation 6.62
Primary

Mindful Parenting Via Self-report Measure Interpersonal Mindfulness in Parenting (IEMP)

The Interpersonal Mindfulness in Parenting (IEMP) scale is a 10-item measure to investigate the quality of interpersonal mindfulness in parenting. Items are answered on a 5-point Likert scale ranging from never true to always true. Four items (#s 1,5,9, and 10) are reverse coded. Total score is the sum of all the item scores, ranging from 10 to 50. Higher scores indicate higher quality of Mindful parenting.

Time frame: Change from baseline at endpoint (3-4 months post-baseline)

Population: The number analyzed in the endpoint and change rows is different from the baseline row because we were not able to retain every participant for the post-intervention data collection.

ArmMeasureGroupValue (MEAN)Dispersion
KEEP-PMindful Parenting Via Self-report Measure Interpersonal Mindfulness in Parenting (IEMP)Change0.81 score on a scaleStandard Deviation 2.67
KEEP-PMindful Parenting Via Self-report Measure Interpersonal Mindfulness in Parenting (IEMP)Baseline37.87 score on a scaleStandard Deviation 3.33
KEEP-PMindful Parenting Via Self-report Measure Interpersonal Mindfulness in Parenting (IEMP)Endpoint38.8 score on a scaleStandard Deviation 3.36
KEEP-P+Mindful Parenting Via Self-report Measure Interpersonal Mindfulness in Parenting (IEMP)Endpoint37.56 score on a scaleStandard Deviation 4
KEEP-P+Mindful Parenting Via Self-report Measure Interpersonal Mindfulness in Parenting (IEMP)Change0.69 score on a scaleStandard Deviation 4.03
KEEP-P+Mindful Parenting Via Self-report Measure Interpersonal Mindfulness in Parenting (IEMP)Baseline37.17 score on a scaleStandard Deviation 4.55
Primary

Observed Level of Child Inhibitory Control Via Bear/Dragon Task

In the Bear/Dragon Task, children were presented with a nice bear and a mean dragon and instructed to do what the bear says (e.g., touch your nose), but not to do what the dragon says. Children's compliance was scored on a 4-point scale on 5 bear trials (0 = failure to move; 1 = a wrong movement; 2 = a partial movement; 3 = a full correct movement) and 5 dragon trials (0 = a full commanded movement; 1 = a partial commanded movement; 2 = a flinch or wrong movement; 3 = no movement). Scores of each trial are summed up to produce a total score ranging from 0 to 30. A higher score indicates better inhibitory control.

Time frame: Change from baseline at endpoint (3-4 months post-baseline)

Population: The number analyzed in the endpoint and change rows is different from the baseline row because we were not able to retain every participant for the post-intervention data collection.

ArmMeasureGroupValue (MEAN)Dispersion
KEEP-PObserved Level of Child Inhibitory Control Via Bear/Dragon TaskBaseline21.52 total scoreStandard Deviation 7.58
KEEP-PObserved Level of Child Inhibitory Control Via Bear/Dragon TaskEndpoint23.6 total scoreStandard Deviation 6.81
KEEP-PObserved Level of Child Inhibitory Control Via Bear/Dragon TaskChange1.56 total scoreStandard Deviation 6.41
KEEP-P+Observed Level of Child Inhibitory Control Via Bear/Dragon TaskBaseline20.42 total scoreStandard Deviation 8.25
KEEP-P+Observed Level of Child Inhibitory Control Via Bear/Dragon TaskEndpoint22.42 total scoreStandard Deviation 7.37
KEEP-P+Observed Level of Child Inhibitory Control Via Bear/Dragon TaskChange3.24 total scoreStandard Deviation 8.5
Primary

Observed Level of Child Inhibitory Control Via Delay Choice Paradigm

In the Delay Choice Paradigm, children were asked to make choices between getting one penny/sticker/treat now or four (or more) to bring home for nine times. Total score is the total times when the child chooses the bring home option (ranges from 0 to 9). Higher score indicates better ability for child to delay gratification, i.e. better inhibitory control.

Time frame: Change from baseline at endpoint (3-4 months post-baseline)

Population: The number analyzed in the endpoint and change rows is different from the baseline row because we were not able to retain every participant for the post-intervention data collection.

ArmMeasureGroupValue (MEAN)Dispersion
KEEP-PObserved Level of Child Inhibitory Control Via Delay Choice ParadigmBaseline4.86 score on a scaleStandard Deviation 3.11
KEEP-PObserved Level of Child Inhibitory Control Via Delay Choice ParadigmEndpoint5.24 score on a scaleStandard Deviation 3.26
KEEP-PObserved Level of Child Inhibitory Control Via Delay Choice ParadigmChange0.19 score on a scaleStandard Deviation 3.13
KEEP-P+Observed Level of Child Inhibitory Control Via Delay Choice ParadigmBaseline5.55 score on a scaleStandard Deviation 2.91
KEEP-P+Observed Level of Child Inhibitory Control Via Delay Choice ParadigmEndpoint4.54 score on a scaleStandard Deviation 3.5
KEEP-P+Observed Level of Child Inhibitory Control Via Delay Choice ParadigmChange-0.89 score on a scaleStandard Deviation 3.41
Primary

Observed Level of Child Working Memory Via Spin the Pots Task

In the Spin the Pots Task, several visually distinct boxes were arranged on a rotating tray (2.5-year -olds: 8 boxes; 3-year-olds: 9 boxes; 3.5 year olds: 10 boxes; 4-year-olds; 11 boxes). Children watched the experimenter hide colourful stickers inside all but two boxes, cover the boxes with a cloth, and rotate a tray for a few seconds to mark the beginning of a search trial. The cloth was removed and children were instructed to select a box to find a sticker. If a sticker was found, children were allowed to keep it. After each search attempt, the tray was covered and rotated again to mark the beginning of the next search trial. The task was completed once children found all hidden stickers or after the allotted number of trials (2.5-year -olds: 12 trials; 3-year-olds: 14 trials; 3.5 year olds: 16 trials; 4-year-olds; 18 trials). Ratio of stickers found to number of trials ranges from 0 to 1. A higher score indicates better working memory.

Time frame: Change from baseline at endpoint (3-4 months post-baseline)

Population: The number analyzed in the endpoint and change rows is different from the baseline row because we were not able to retain every participant for the post-intervention data collection.

ArmMeasureGroupValue (MEAN)Dispersion
KEEP-PObserved Level of Child Working Memory Via Spin the Pots TaskEndpoint0.62 Ratio of stickers found to trialsStandard Deviation 0.2
KEEP-PObserved Level of Child Working Memory Via Spin the Pots TaskChange0.05 Ratio of stickers found to trialsStandard Deviation 0.22
KEEP-PObserved Level of Child Working Memory Via Spin the Pots TaskBaseline0.58 Ratio of stickers found to trialsStandard Deviation 0.16
KEEP-P+Observed Level of Child Working Memory Via Spin the Pots TaskBaseline0.55 Ratio of stickers found to trialsStandard Deviation 0.16
KEEP-P+Observed Level of Child Working Memory Via Spin the Pots TaskEndpoint0.59 Ratio of stickers found to trialsStandard Deviation 0.18
KEEP-P+Observed Level of Child Working Memory Via Spin the Pots TaskChange0.06 Ratio of stickers found to trialsStandard Deviation 0.23
Primary

Observed Level of Developmentally-supportive Parenting Via Observational Measure Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)

The Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO) is an observational measure which rates developmentally-supportive parenting across four domains: affection, responsiveness, encouragement, and teaching. It is a checklist of 29 items reflecting positive parent-child interaction behaviors. Each behavior is rated according to their frequency as 0 (absent, no behavior observed), 1 (barely, minor or emerging behavior) and 2 (clearly, definitive, strong and frequent behavior). Higher scores indicating higher levels of positive parenting. PICCOLO total score is calculated by summing up scores of all the 29 items, ranging from 0 to 58.

Time frame: Change from baseline at endpoint (3-4 months post-baseline)

Population: The number analyzed in the endpoint and change rows is different from the baseline row because we were not able to retain every participant for the post-intervention data collection.

ArmMeasureGroupValue (MEAN)Dispersion
KEEP-PObserved Level of Developmentally-supportive Parenting Via Observational Measure Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)Baseline42.58 score on a scaleStandard Deviation 7.22
KEEP-PObserved Level of Developmentally-supportive Parenting Via Observational Measure Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)Endpoint42.85 score on a scaleStandard Deviation 8.45
KEEP-PObserved Level of Developmentally-supportive Parenting Via Observational Measure Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)Change0.14 score on a scaleStandard Deviation 8.67
KEEP-P+Observed Level of Developmentally-supportive Parenting Via Observational Measure Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)Baseline43.36 score on a scaleStandard Deviation 6.65
KEEP-P+Observed Level of Developmentally-supportive Parenting Via Observational Measure Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)Endpoint43.08 score on a scaleStandard Deviation 7.65
KEEP-P+Observed Level of Developmentally-supportive Parenting Via Observational Measure Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)Change-0.76 score on a scaleStandard Deviation 8.57
Primary

Parental Stress Via Caregiver-report Measure Parent Daily Report (PDR)

The Parent Daily Report (PDR) is a caregiver-report measure assessing child behaviour problems and associated parental stress occurring in the past 24 hours. The measure has several versions. The version used in the present research is the Oregon Social Learning Center Community Programs PDR which has 39 questions with only negative child behaviors, targeting to children from 3 to 6 years. Caregivers rate each child behavior as 0 = Did Not Occur, 1 = Occurred & Not Stressful, 2 = Occurred & Stressful. The PDR was administered 3 times per wave. For each response, total score of stressful behaviors was calculated by counting the number of behaviors rated as 2 = Occurred & Stressful. Then the three total scores was averaged to get the mean of stressful behaviors (ranges from 0 to 39) as a indicator of parental stress. Higher score indicates higher level of parental stress.

Time frame: Change from baseline at endpoint (3-4 months post-baseline)

Population: The number analyzed in the endpoint and change rows is different from the baseline row because we were not able to retain every participant for the post-intervention data collection.

ArmMeasureGroupValue (MEAN)Dispersion
KEEP-PParental Stress Via Caregiver-report Measure Parent Daily Report (PDR)Baseline6.56 score on a scaleStandard Deviation 5.65
KEEP-PParental Stress Via Caregiver-report Measure Parent Daily Report (PDR)Endpoint4.48 score on a scaleStandard Deviation 4.81
KEEP-PParental Stress Via Caregiver-report Measure Parent Daily Report (PDR)Change-1.9 score on a scaleStandard Deviation 4.59
KEEP-P+Parental Stress Via Caregiver-report Measure Parent Daily Report (PDR)Baseline7.26 score on a scaleStandard Deviation 5.36
KEEP-P+Parental Stress Via Caregiver-report Measure Parent Daily Report (PDR)Endpoint4.58 score on a scaleStandard Deviation 4.11
KEEP-P+Parental Stress Via Caregiver-report Measure Parent Daily Report (PDR)Change-2.8 score on a scaleStandard Deviation 3.98
Primary

Parenting Stress Via Self-report Measure Parenting Stress Index IV (PSI-IV) Short Form

The Parenting Stress Index IV (PSI-IV) Short Form evaluates the magnitude of stress in the parent-child relationship based on the parent's perception of the child's characteristics, the personal characteristics of the parent, and the interaction between the parent and child. It is a 5-point Likert scale ranging from strongly agree to strongly disagree with 36 items. Item 32 is the only item which is reverse coded. For all the other items, higher scores indicate higher levels of stress. Total parenting stress score is calculated by summing up scores of all the 36 items, ranging from 36 to 180.

Time frame: Change from baseline at endpoint (3-4 months post-baseline)

Population: The number analyzed in the endpoint and change rows is different from the baseline row because we were not able to retain every participant for the post-intervention data collection.

ArmMeasureGroupValue (MEAN)Dispersion
KEEP-PParenting Stress Via Self-report Measure Parenting Stress Index IV (PSI-IV) Short FormBaseline80.87 score on a scaleStandard Deviation 20.28
KEEP-PParenting Stress Via Self-report Measure Parenting Stress Index IV (PSI-IV) Short FormEndpoint74.62 score on a scaleStandard Deviation 20.29
KEEP-PParenting Stress Via Self-report Measure Parenting Stress Index IV (PSI-IV) Short FormChange-5.29 score on a scaleStandard Deviation 9.45
KEEP-P+Parenting Stress Via Self-report Measure Parenting Stress Index IV (PSI-IV) Short FormBaseline86.18 score on a scaleStandard Deviation 23.83
KEEP-P+Parenting Stress Via Self-report Measure Parenting Stress Index IV (PSI-IV) Short FormEndpoint80.8 score on a scaleStandard Deviation 22.76
KEEP-P+Parenting Stress Via Self-report Measure Parenting Stress Index IV (PSI-IV) Short FormChange-5.72 score on a scaleStandard Deviation 13.97
Primary

Preschool and Kindergarten Behavior Scales (PKBS)

Caregivers perception of their child's behaviors via the Preschool and Kindergarten Behavior Scales (PKBS). Items are on a 4-point scale ranging from never to often. Higher scores indicate more behavior problems. PKBS total score (76 items) sum score ranging between 0-228.

Time frame: Change from baseline at endpoint (3-4 months post-baseline)

Population: The number analyzed in the endpoint and change rows is different from the baseline row because we were not able to retain every participant for the post-intervention data collection.

ArmMeasureGroupValue (MEAN)Dispersion
KEEP-PPreschool and Kindergarten Behavior Scales (PKBS)Baseline55.86 total score on scaleStandard Deviation 19.56
KEEP-PPreschool and Kindergarten Behavior Scales (PKBS)Endpoint50.6 total score on scaleStandard Deviation 21.93
KEEP-PPreschool and Kindergarten Behavior Scales (PKBS)Change-3.44 total score on scaleStandard Deviation 10.8
KEEP-P+Preschool and Kindergarten Behavior Scales (PKBS)Change-3.09 total score on scaleStandard Deviation 11.02
KEEP-P+Preschool and Kindergarten Behavior Scales (PKBS)Baseline54.63 total score on scaleStandard Deviation 19.7
KEEP-P+Preschool and Kindergarten Behavior Scales (PKBS)Endpoint52.39 total score on scaleStandard Deviation 18.3
Primary

Silly Animal Categories

Proportion of animals sorted correctly after rule switch. Higher score indicates better executive functioning.

Time frame: Change from baseline at endpoint (3-4 months post-baseline)

Population: The number analyzed in the endpoint and change rows is different from the baseline row because we were not able to retain every participant for the post-intervention data collection.

ArmMeasureGroupValue (MEAN)Dispersion
KEEP-PSilly Animal CategoriesBaseline0.64 proportion correctStandard Deviation 0.38
KEEP-PSilly Animal CategoriesEndpoint0.67 proportion correctStandard Deviation 0.35
KEEP-PSilly Animal CategoriesChange0.05 proportion correctStandard Deviation 0.33
KEEP-P+Silly Animal CategoriesBaseline0.61 proportion correctStandard Deviation 0.34
KEEP-P+Silly Animal CategoriesEndpoint0.71 proportion correctStandard Deviation 0.31
KEEP-P+Silly Animal CategoriesChange0.1 proportion correctStandard Deviation 0.31

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