Trial Outcomes & Findings for Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers (KEEP-P) (NCT NCT03106636)

NCT ID: NCT03106636

Last Updated: 2020-07-14

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 442 participants
• Primary outcome timeframe: Change from baseline at endpoint (3-4 months post-baseline)
• Results posted on: 2020-07-14

Participant Flow

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+)

Participant milestones

Measure	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.	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.
Overall Study STARTED	226	190
Overall Study COMPLETED	182	164
Overall Study NOT COMPLETED	44	26

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Numbers are different due to missing data.

Baseline characteristics by cohort

Measure	KEEP-P n=226 Participants 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.	KEEP-P+ n=190 Participants 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.	Total n=416 Participants Total of all reporting groups
Age, Categorical <=18 years	107 Participants n=216 Participants • Numbers are different due to missing data.	90 Participants n=181 Participants • Numbers are different due to missing data.	197 Participants n=397 Participants • Numbers are different due to missing data.
Age, Categorical Between 18 and 65 years	101 Participants n=216 Participants • Numbers are different due to missing data.	90 Participants n=181 Participants • Numbers are different due to missing data.	191 Participants n=397 Participants • Numbers are different due to missing data.
Age, Categorical >=65 years	8 Participants n=216 Participants • Numbers are different due to missing data.	1 Participants n=181 Participants • Numbers are different due to missing data.	9 Participants n=397 Participants • Numbers are different due to missing data.
Age, Continuous Caregivers	48.62 years STANDARD_DEVIATION 11.355 • n=226 Participants	45.86 years STANDARD_DEVIATION 9.63 • n=190 Participants	47.37 years STANDARD_DEVIATION 10.669 • n=416 Participants
Age, Continuous Children	2.61 years STANDARD_DEVIATION .888 • n=226 Participants	2.32 years STANDARD_DEVIATION .633 • n=190 Participants	2.48 years STANDARD_DEVIATION .793 • n=416 Participants
Sex: Female, Male Female	126 Participants n=217 Participants • Numbers are different due to missing data.	114 Participants n=181 Participants • Numbers are different due to missing data.	240 Participants n=398 Participants • Numbers are different due to missing data.
Sex: Female, Male Male	91 Participants n=217 Participants • Numbers are different due to missing data.	67 Participants n=181 Participants • Numbers are different due to missing data.	158 Participants n=398 Participants • Numbers are different due to missing data.
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=226 Participants	27 Participants n=190 Participants	40 Participants n=416 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	169 Participants n=226 Participants	155 Participants n=190 Participants	324 Participants n=416 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	44 Participants n=226 Participants	8 Participants n=190 Participants	52 Participants n=416 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=226 Participants	2 Participants n=190 Participants	4 Participants n=416 Participants
Race (NIH/OMB) Asian	7 Participants n=226 Participants	0 Participants n=190 Participants	7 Participants n=416 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=226 Participants	1 Participants n=190 Participants	1 Participants n=416 Participants
Race (NIH/OMB) Black or African American	3 Participants n=226 Participants	1 Participants n=190 Participants	4 Participants n=416 Participants
Race (NIH/OMB) White	126 Participants n=226 Participants	131 Participants n=190 Participants	257 Participants n=416 Participants
Race (NIH/OMB) More than one race	40 Participants n=226 Participants	39 Participants n=190 Participants	79 Participants n=416 Participants
Race (NIH/OMB) Unknown or Not Reported	48 Participants n=226 Participants	16 Participants n=190 Participants	64 Participants n=416 Participants
Region of Enrollment United States	226 participants n=226 Participants	190 participants n=190 Participants	416 participants n=416 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	KEEP-P n=82 Participants 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.	KEEP-P+ n=84 Participants 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.
Parenting Stress Via Self-report Measure Parenting Stress Index IV (PSI-IV) Short Form Baseline	80.87 score on a scale Standard Deviation 20.28	86.18 score on a scale Standard Deviation 23.83
Parenting Stress Via Self-report Measure Parenting Stress Index IV (PSI-IV) Short Form Endpoint	74.62 score on a scale Standard Deviation 20.29	80.8 score on a scale Standard Deviation 22.76
Parenting Stress Via Self-report Measure Parenting Stress Index IV (PSI-IV) Short Form Change	-5.29 score on a scale Standard Deviation 9.45	-5.72 score on a scale Standard Deviation 13.97

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	KEEP-P n=81 Participants 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.	KEEP-P+ n=83 Participants 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.
Caregiver's Perceived Sense of Competency in Parenting Via Self-report Measure Parent Sense of Competency Scale (PSOC) Baseline	49.42 score on a scale Standard Deviation 5.18	49.82 score on a scale Standard Deviation 6.33
Caregiver's Perceived Sense of Competency in Parenting Via Self-report Measure Parent Sense of Competency Scale (PSOC) Endpoint	51.6 score on a scale Standard Deviation 5.46	50.15 score on a scale Standard Deviation 5.22
Caregiver's Perceived Sense of Competency in Parenting Via Self-report Measure Parent Sense of Competency Scale (PSOC) Change	2.14 score on a scale Standard Deviation 3.39	0.3 score on a scale Standard Deviation 4.84

PRIMARY outcome

Timeframe: 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.

"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. "

Outcome measures

Measure	KEEP-P n=84 Participants 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.	KEEP-P+ n=86 Participants 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.
Observed Level of Developmentally-supportive Parenting Via Observational Measure Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO) Endpoint	42.85 score on a scale Standard Deviation 8.45	43.08 score on a scale Standard Deviation 7.65
Observed Level of Developmentally-supportive Parenting Via Observational Measure Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO) Change	0.14 score on a scale Standard Deviation 8.67	-0.76 score on a scale Standard Deviation 8.57
Observed Level of Developmentally-supportive Parenting Via Observational Measure Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO) Baseline	42.58 score on a scale Standard Deviation 7.22	43.36 score on a scale Standard Deviation 6.65

PRIMARY outcome

Timeframe: 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.

"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."

Outcome measures

Measure	KEEP-P n=83 Participants 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.	KEEP-P+ n=82 Participants 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.
Frequency of Family Routines Via Self-report Measure Family Routines Questionnaire (FRQ) Baseline	51.66 score on a scale Standard Deviation 11.66	50.43 score on a scale Standard Deviation 9
Frequency of Family Routines Via Self-report Measure Family Routines Questionnaire (FRQ) Endpoint	52.63 score on a scale Standard Deviation 9.79	52.09 score on a scale Standard Deviation 9.32
Frequency of Family Routines Via Self-report Measure Family Routines Questionnaire (FRQ) Change	1.37 score on a scale Standard Deviation 10.34	1.3 score on a scale Standard Deviation 6.62

PRIMARY outcome

Timeframe: 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.

"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."

Outcome measures

Measure	KEEP-P n=83 Participants 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.	KEEP-P+ n=84 Participants 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.
Mindful Parenting Via Self-report Measure Interpersonal Mindfulness in Parenting (IEMP) Baseline	37.87 score on a scale Standard Deviation 3.33	37.17 score on a scale Standard Deviation 4.55
Mindful Parenting Via Self-report Measure Interpersonal Mindfulness in Parenting (IEMP) Endpoint	38.8 score on a scale Standard Deviation 3.36	37.56 score on a scale Standard Deviation 4
Mindful Parenting Via Self-report Measure Interpersonal Mindfulness in Parenting (IEMP) Change	0.81 score on a scale Standard Deviation 2.67	0.69 score on a scale Standard Deviation 4.03

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	KEEP-P n=83 Participants 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.	KEEP-P+ n=83 Participants 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.
Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY) Baseline Proximity	7.53 score on a scale Standard Deviation 3.89	8.42 score on a scale Standard Deviation 3.73
Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY) Endpoint Proximity	7.75 score on a scale Standard Deviation 3.83	7.87 score on a scale Standard Deviation 3.78
Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY) Change Proximity	0.22 score on a scale Standard Deviation 3.41	-0.49 score on a scale Standard Deviation 4.17
Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY) Baseline Avoidance	1.84 score on a scale Standard Deviation 2.22	1.95 score on a scale Standard Deviation 2.19
Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY) Endpoint Avoidance	1.78 score on a scale Standard Deviation 2.33	2.06 score on a scale Standard Deviation 2.53
Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY) Change Avoidance	-0.03 score on a scale Standard Deviation 2.15	-0.04 score on a scale Standard Deviation 2.22
Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY) Baseline Resistance	0.72 score on a scale Standard Deviation 1.03	0.88 score on a scale Standard Deviation 1.15
Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY) Endpoint Resistance	0.57 score on a scale Standard Deviation 1.08	0.70 score on a scale Standard Deviation 0.99
Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY) Change Resistance	-0.08 score on a scale Standard Deviation 0.95	-0.21 score on a scale Standard Deviation 1.10

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	KEEP-P n=85 Participants 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.	KEEP-P+ n=83 Participants 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.
Child Internalizing/Externalizing Symptoms and Total Behavior Score Via Caregiver-report Measure Child Behaviour Checklist (CBCL) Baseline	59.6 T-score Standard Deviation 12.13	61.65 T-score Standard Deviation 11.72
Child Internalizing/Externalizing Symptoms and Total Behavior Score Via Caregiver-report Measure Child Behaviour Checklist (CBCL) Endpoint	57.18 T-score Standard Deviation 12.44	57.47 T-score Standard Deviation 12.14
Child Internalizing/Externalizing Symptoms and Total Behavior Score Via Caregiver-report Measure Child Behaviour Checklist (CBCL) Change	-3.24 T-score Standard Deviation 6.95	-3.76 T-score Standard Deviation 6.63

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	KEEP-P n=80 Participants 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.	KEEP-P+ n=82 Participants 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.
Preschool and Kindergarten Behavior Scales (PKBS) Baseline	55.86 total score on scale Standard Deviation 19.56	54.63 total score on scale Standard Deviation 19.7
Preschool and Kindergarten Behavior Scales (PKBS) Endpoint	50.6 total score on scale Standard Deviation 21.93	52.39 total score on scale Standard Deviation 18.3
Preschool and Kindergarten Behavior Scales (PKBS) Change	-3.44 total score on scale Standard Deviation 10.8	-3.09 total score on scale Standard Deviation 11.02

PRIMARY outcome

Timeframe: 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.

"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."

Outcome measures

Measure	KEEP-P n=84 Participants 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.	KEEP-P+ n=84 Participants 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.
Parental Stress Via Caregiver-report Measure Parent Daily Report (PDR) Endpoint	4.48 score on a scale Standard Deviation 4.81	4.58 score on a scale Standard Deviation 4.11
Parental Stress Via Caregiver-report Measure Parent Daily Report (PDR) Baseline	6.56 score on a scale Standard Deviation 5.65	7.26 score on a scale Standard Deviation 5.36
Parental Stress Via Caregiver-report Measure Parent Daily Report (PDR) Change	-1.9 score on a scale Standard Deviation 4.59	-2.8 score on a scale Standard Deviation 3.98

PRIMARY outcome

Timeframe: 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.

"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."

Outcome measures

Measure	KEEP-P n=85 Participants 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.	KEEP-P+ n=86 Participants 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.
Child Social-emotional Development Via Caregiver-report Measure Ages and Stages Questionnaire: Social-Emotional (ASQ:SE) Baseline	121.35 score on a scale Standard Deviation 77.58	125.81 score on a scale Standard Deviation 66.21
Child Social-emotional Development Via Caregiver-report Measure Ages and Stages Questionnaire: Social-Emotional (ASQ:SE) Endpoint	105 score on a scale Standard Deviation 74.47	119.13 score on a scale Standard Deviation 71.29
Child Social-emotional Development Via Caregiver-report Measure Ages and Stages Questionnaire: Social-Emotional (ASQ:SE) Change	-14.33 score on a scale Standard Deviation 33.95	-2.39 score on a scale Standard Deviation 42.64

PRIMARY outcome

Timeframe: 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.

"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."

Outcome measures

Measure	KEEP-P n=72 Participants 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.	KEEP-P+ n=75 Participants 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.
Observed Level of Child Inhibitory Control Via Delay Choice Paradigm Baseline	4.86 score on a scale Standard Deviation 3.11	5.55 score on a scale Standard Deviation 2.91
Observed Level of Child Inhibitory Control Via Delay Choice Paradigm Endpoint	5.24 score on a scale Standard Deviation 3.26	4.54 score on a scale Standard Deviation 3.5
Observed Level of Child Inhibitory Control Via Delay Choice Paradigm Change	0.19 score on a scale Standard Deviation 3.13	-0.89 score on a scale Standard Deviation 3.41

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	KEEP-P n=78 Participants 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.	KEEP-P+ n=80 Participants 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.
Dimensional Change Card Sort (DCCS) Change	0.48 number of phases passed Standard Deviation 1.29	0.43 number of phases passed Standard Deviation 1.37
Dimensional Change Card Sort (DCCS) Baseline	1.76 number of phases passed Standard Deviation 1.43	1.61 number of phases passed Standard Deviation 1.32
Dimensional Change Card Sort (DCCS) Endpoint	2.12 number of phases passed Standard Deviation 1.54	2.05 number of phases passed Standard Deviation 1.54

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	KEEP-P n=64 Participants 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.	KEEP-P+ n=65 Participants 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.
Observed Level of Child Inhibitory Control Via Bear/Dragon Task Baseline	21.52 total score Standard Deviation 7.58	20.42 total score Standard Deviation 8.25
Observed Level of Child Inhibitory Control Via Bear/Dragon Task Endpoint	23.6 total score Standard Deviation 6.81	22.42 total score Standard Deviation 7.37
Observed Level of Child Inhibitory Control Via Bear/Dragon Task Change	1.56 total score Standard Deviation 6.41	3.24 total score Standard Deviation 8.5

PRIMARY outcome

Timeframe: 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.

"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."

Outcome measures

Measure	KEEP-P n=81 Participants 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.	KEEP-P+ n=79 Participants 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.
Observed Level of Child Working Memory Via Spin the Pots Task Endpoint	0.62 Ratio of stickers found to trials Standard Deviation .2	0.59 Ratio of stickers found to trials Standard Deviation .18
Observed Level of Child Working Memory Via Spin the Pots Task Baseline	0.58 Ratio of stickers found to trials Standard Deviation .16	0.55 Ratio of stickers found to trials Standard Deviation .16
Observed Level of Child Working Memory Via Spin the Pots Task Change	0.05 Ratio of stickers found to trials Standard Deviation .22	0.06 Ratio of stickers found to trials Standard Deviation .23

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	KEEP-P n=76 Participants 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.	KEEP-P+ n=80 Participants 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.
Silly Animal Categories Change	0.05 proportion correct Standard Deviation .33	0.1 proportion correct Standard Deviation 0.31
Silly Animal Categories Baseline	0.64 proportion correct Standard Deviation .38	0.61 proportion correct Standard Deviation .34
Silly Animal Categories Endpoint	0.67 proportion correct Standard Deviation .35	0.71 proportion correct Standard Deviation .31

PRIMARY outcome

Timeframe: 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.

"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."

Outcome measures

Measure	KEEP-P n=68 Participants 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.	KEEP-P+ n=67 Participants 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.
Child Executive Function Via Kansas Reflection-Impulsivity Scale for Preschoolers (KRISP) Baseline	35.76 score on a scale Standard Deviation 7.9	33.52 score on a scale Standard Deviation 7.78
Child Executive Function Via Kansas Reflection-Impulsivity Scale for Preschoolers (KRISP) Endpoint	37.81 score on a scale Standard Deviation 6.23	35.8 score on a scale Standard Deviation 7.6
Child Executive Function Via Kansas Reflection-Impulsivity Scale for Preschoolers (KRISP) Change	2.16 score on a scale Standard Deviation 8.97	3.96 score on a scale Standard Deviation 7.55

Adverse Events

KEEP-P

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

KEEP-P+

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Philip Fisher

University of Oregon

Phone: 541-346-4968

Email: philf@uoregon.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place