Child BehaviorKEEP-PNCT03106636
Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers (KEEP-P)
A study testing KEEP-P and KEEP-P+ in people with Child Behavior, run by University of Oregon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavior
- What is being tested?
- KEEP-P and KEEP-P+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2014to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preschool-aged foster children
- Preschool-aged children referred to early intervention/childhood special education services
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers
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.
Read the 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.
- Conditions
- Child Behavior
- Being tested
- KEEP-P, KEEP-P+
- 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
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KEEP-PBehavioural
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.
KEEP-P+Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| KEEP-P | Active comparator | 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. Receives: Behavioral: KEEP-P |
| KEEP-P+ | Experimental | 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. Receives: Behavioral: KEEP-P+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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. "
Measured: 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."
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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.
Measured: 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."
Measured: Change from baseline at endpoint (3-4 months post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start20 May 2014
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (140)Papers the sponsor has linked to this study.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Social Learning Center
- Responsible party
- Principal investigator, Phil Fisher, University of Oregon
- Investigators
- Philip A Fisher, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106636
- Sponsor's protocol ID
- 06112013.016
- Acronym
- KEEP-P
- Status last verified
- Jul 2020
- First submitted
- 4 Jun 2015
- Last updated
- 14 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD data will be shared with other researchers upon completion of the data set as well as completion of a data sharing agreement.
Publications
Aarons GA, Brown SA, Hough RL, Garland AF, Wood PA. Prevalence of adolescent substance use disorders across five sectors of care. J Am Acad Child Adolesc Psychiatry. 2001 Apr;40(4):419-26. doi: 10.1097/00004583-200104000-00010.
PubMed 11314567Barth, R. P., Scarborough, A. A., Lloyd, C. E., Losby, J. L., Casanueva, C., & Mann, T. (2007). Developmental status and early intervention service needs of maltreated children. Washington, DC: U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation.
Bonomi AE, Cannon EA, Anderson ML, Rivara FP, Thompson RS. Association between self-reported health and physical and/or sexual abuse experienced before age 18. Child Abuse Negl. 2008 Jul;32(7):693-701. doi: 10.1016/j.chiabu.2007.10.004. Epub 2008 Jul 7.
PubMed 18602692Chartier MJ, Walker JR, Naimark B. Separate and cumulative effects of adverse childhood experiences in predicting adult health and health care utilization. Child Abuse Negl. 2010 Jun;34(6):454-64. doi: 10.1016/j.chiabu.2009.09.020. Epub 2010 Apr 20.
PubMed 20409586English DJ, Graham JC, Litrownik AJ, Everson M, Bangdiwala SI. Defining maltreatment chronicity: are there differences in child outcomes? Child Abuse Negl. 2005 May;29(5):575-95. doi: 10.1016/j.chiabu.2004.08.009.
PubMed 15970326Fantuzzo, J. W., & Perlman, S. M. (2007). The unique impact of out-of-home placement and the mediating effects of child maltreatment and homelessness on early school success. Children and Youth Services Review, 29, 941-960.
Fisher, P. A., & Gunnar, M. R. (2010). Early life stress as a risk factor for disease in childhood. In R. A. Lanius, E. Vermetten & C. Pain (Eds.), The impact of early life trauma on health and disease (pp. 133-141). Cambridge, UK: Cambridge University Press.
Garland AF, Hough RL, McCabe KM, Yeh M, Wood PA, Aarons GA. Prevalence of psychiatric disorders in youths across five sectors of care. J Am Acad Child Adolesc Psychiatry. 2001 Apr;40(4):409-18. doi: 10.1097/00004583-200104000-00009.
PubMed 11314566Kaplow JB, Widom CS. Age of onset of child maltreatment predicts long-term mental health outcomes. J Abnorm Psychol. 2007 Feb;116(1):176-87. doi: 10.1037/0021-843X.116.1.176.
PubMed 17324028Keiley MK, Howe TR, Dodge KA, Bates JE, Petti GS. The timing of child physical maltreatment: a cross-domain growth analysis of impact on adolescent externalizing and internalizing problems. Dev Psychopathol. 2001 Fall;13(4):891-912.
PubMed 11771913Lewis DO, Pincus JH, Lovely R, Spitzer E, Moy E. Biopsychosocial characteristics of matched samples of delinquents and nondelinquents. J Am Acad Child Adolesc Psychiatry. 1987 Sep;26(5):744-52. doi: 10.1097/00004583-198709000-00022. No abstract available.
PubMed 3667506McCluskey, C. P., Krohn, M. D., Lizotte, A. J., & Rodriguez, M. L. (2002). Early substance use and school achievement: An examination of Latino, White, and African American youth. Journal of Drug Issues, 32, 921-943.
Pawlby SJ, Mills A, Quinton D. Vulnerable adolescent girls: opposite-sex relationships. J Child Psychol Psychiatry. 1997 Nov;38(8):909-20. doi: 10.1111/j.1469-7610.1997.tb01610.x.
PubMed 9413791Schneiderman JU, Leslie LK, Arnold-Clark JS, McDaniel D, Xie B. Pediatric health assessments of young children in child welfare by placement type. Child Abuse Negl. 2011 Jan;35(1):29-39. doi: 10.1016/j.chiabu.2010.06.007.
PubMed 21316106Tarren-Sweeney M, Hazell P. Mental health of children in foster and kinship care in New South Wales, Australia. J Paediatr Child Health. 2006 Mar;42(3):89-97. doi: 10.1111/j.1440-1754.2006.00804.x.
PubMed 16509906
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers
- ClinicalTrials.gov ID
- NCT03106636
- Acronym / sponsor ID
- KEEP-P / 06112013.016
- Conditions
- Child Behavior
- Keywords
- Preschool-aged, Foster children, child welfare, Fostercare, Parent training, early adversity, curriculum based, early intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- Oregon Social Learning Center
- Study start
- 20 May 2014 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Posted 14 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KEEP-P | Active comparator | Behavioral: KEEP-PCaregivers 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. |
| KEEP-P+ | Experimental | Behavioral: KEEP-P+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. |
Who may qualify
- Ages
- 30 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preschool-aged foster children
- Preschool-aged children referred to early intervention/childhood special education services
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KEEP-PThe 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. | Behavioural | KEEP-P |
| KEEP-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. | Behavioural | KEEP-P+ |
Primary outcome
Parenting Stress Via Self-report Measure Parenting Stress Index IV (PSI-IV) Short Form
Time frame: Change 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 Paradigm
Time frame: Change 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)
Time frame: 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 Task
Time frame: Change 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 Task
Time frame: Change 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 Categories
Time frame: Change 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)
Time frame: 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."
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11314567Aarons GA, Brown SA, Hough RL, Garland AF, Wood PA. Prevalence of adolescent substance use disorders across five sectors of care. J Am Acad Child Adolesc Psychiatry. 2001 Apr;40(4):419-26. doi: 10.1097/00004583-200104000-00010.
- BackgroundBarth, R. P., Scarborough, A. A., Lloyd, C. E., Losby, J. L., Casanueva, C., & Mann, T. (2007). Developmental status and early intervention service needs of maltreated children. Washington, DC: U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation.
- Background: PubMed 18602692Bonomi AE, Cannon EA, Anderson ML, Rivara FP, Thompson RS. Association between self-reported health and physical and/or sexual abuse experienced before age 18. Child Abuse Negl. 2008 Jul;32(7):693-701. doi: 10.1016/j.chiabu.2007.10.004. Epub 2008 Jul 7.
- Background: PubMed 20409586Chartier MJ, Walker JR, Naimark B. Separate and cumulative effects of adverse childhood experiences in predicting adult health and health care utilization. Child Abuse Negl. 2010 Jun;34(6):454-64. doi: 10.1016/j.chiabu.2009.09.020. Epub 2010 Apr 20.
- Background: PubMed 15970326English DJ, Graham JC, Litrownik AJ, Everson M, Bangdiwala SI. Defining maltreatment chronicity: are there differences in child outcomes? Child Abuse Negl. 2005 May;29(5):575-95. doi: 10.1016/j.chiabu.2004.08.009.
- BackgroundFantuzzo, J. W., & Perlman, S. M. (2007). The unique impact of out-of-home placement and the mediating effects of child maltreatment and homelessness on early school success. Children and Youth Services Review, 29, 941-960.
- BackgroundFisher, P. A., & Gunnar, M. R. (2010). Early life stress as a risk factor for disease in childhood. In R. A. Lanius, E. Vermetten & C. Pain (Eds.), The impact of early life trauma on health and disease (pp. 133-141). Cambridge, UK: Cambridge University Press.
- Background: PubMed 11314566Garland AF, Hough RL, McCabe KM, Yeh M, Wood PA, Aarons GA. Prevalence of psychiatric disorders in youths across five sectors of care. J Am Acad Child Adolesc Psychiatry. 2001 Apr;40(4):409-18. doi: 10.1097/00004583-200104000-00009.
- Background: PubMed 17324028Kaplow JB, Widom CS. Age of onset of child maltreatment predicts long-term mental health outcomes. J Abnorm Psychol. 2007 Feb;116(1):176-87. doi: 10.1037/0021-843X.116.1.176.
- Background: PubMed 11771913Keiley MK, Howe TR, Dodge KA, Bates JE, Petti GS. The timing of child physical maltreatment: a cross-domain growth analysis of impact on adolescent externalizing and internalizing problems. Dev Psychopathol. 2001 Fall;13(4):891-912.
- Background: PubMed 3667506Lewis DO, Pincus JH, Lovely R, Spitzer E, Moy E. Biopsychosocial characteristics of matched samples of delinquents and nondelinquents. J Am Acad Child Adolesc Psychiatry. 1987 Sep;26(5):744-52. doi: 10.1097/00004583-198709000-00022. No abstract available.
- BackgroundMcCluskey, C. P., Krohn, M. D., Lizotte, A. J., & Rodriguez, M. L. (2002). Early substance use and school achievement: An examination of Latino, White, and African American youth. Journal of Drug Issues, 32, 921-943.
- Individual participant dataSharing planned: Yes. De-identified IPD data will be shared with other researchers upon completion of the data set as well as completion of a data sharing agreement.
Related trials for Child Behavior
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Not yet recruiting
Study of Psychoeducation and Reading for Kids (SPARK)
Reading Difficulties, Behavioral Problems
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip A Fisher, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KEEP-P and KEEP-P+ in people with Child Behavior, run by University of Oregon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting Stress Via Self-report Measure Parenting Stress Index IV (PSI-IV) Short Form (time frame: Change from baseline at endpoint (3-4 months post-baseline)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03106636, which also lists 140 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.