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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Child Behavior

Intervention / Treatment
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* Behavioral: KEEP-P
* Behavioral: KEEP-P+


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: KEEP-P<br>Caregivers are randomly assigned to one of two groups. The KEEP-P group completes a basic version of the curriculum. The intervention content is delivered by a KEEP-P group facilitator in a 2-hour weekly group format. Duration of the program is 12 weeks. | Behavioral: KEEP-P<br>* 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.<br>|
| Experimental: KEEP-P+<br>Caregivers are randomly assigned to one of two groups. The KEEP-P+ group completes an augmented version of the intervention with curriculum that includes the addition of information about recent findings in early brain development and a video coaching component based on the Filming Interactions to Nurture Development (FIND) program. The intervention content is delivered by a KEEP-P group facilitator in a 2-hour weekly group format. Duration of the program is 12 weeks. | Behavioral: KEEP-P+<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline at endpoint (3-4 months post-baseline) | 
| 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. | Change from baseline at endpoint (3-4 months post-baseline) | 
| 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.  | Change from baseline at endpoint (3-4 months post-baseline) | 
| 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. | Change from baseline at endpoint (3-4 months post-baseline) | 
| 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. | Change from baseline at endpoint (3-4 months post-baseline) | 
| 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. | Change from baseline at endpoint (3-4 months post-baseline) | 
| 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. | Change from baseline at endpoint (3-4 months post-baseline) | 
| 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. | Change from baseline at endpoint (3-4 months post-baseline) | 
| 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. | Change from baseline at endpoint (3-4 months post-baseline) | 
| 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. | Change from baseline at endpoint (3-4 months post-baseline) | 
| 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. | Change from baseline at endpoint (3-4 months post-baseline) | 
| 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. | Change from baseline at endpoint (3-4 months post-baseline) | 
| 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. | Change from baseline at endpoint (3-4 months post-baseline) | 
| 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. | Change from baseline at endpoint (3-4 months post-baseline) | 
| Silly Animal Categories | Proportion of animals sorted correctly after rule switch. Higher score indicates better executive functioning. | Change from baseline at endpoint (3-4 months post-baseline) | 
| 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. | Change from baseline at endpoint (3-4 months post-baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early intervention, Preschool-aged, Foster children, child welfare, Fostercare, Parent training, early adversity, curriculum based, preschool, foster placement disruptions, manualized intervention, group based intervention, high-risk children