Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548126
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-02
Brief Title:
Evaluation of the Parenting in the Moment Online Program for Forcibly Displaced Families
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Parenting in the Moment Program for Forcibly Displaced Families
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIMonline
Brief Summary:
This Randomized Controlled Trial will test the effectiveness of the Parenting in the Moment PIM online parenting program for parents with experiences of forced displacement
The primary objective of this study is to conduct a summative impact evaluation of the PIM online parenting program as an in-home parent skill-based program for parents of school-aged children using a randomized controlled trial research design with community partnerships that inform the research throughout The longer-term objectives are to build the evidence-base for in-home parent skill-based programs with strong empirical support ie eligible for listing on the Families First Clearinghouse and increase access to parenting programs for forcibly displaced families thereby improving child safety and wellbeing and strengthening their public health support
720 families will be recruited with forced migration backgrounds and within 10 years of arrival in the USA 360 families will be assigned to the PIMonline program and 360 to a family resource list only wait-list control group Families will be recruited using stratified random sampling within the four PIM language groups English Spanish Arabic French Within each language half the families will be assigned to the PIMonline intervention program and the other half will be assigned to receiving a Family Resource List with access to the PIMonline program once the study ends
One parent and one child per eligible family may participate Data collection with participating families will take place at baseline T1 4-months after baseline T2 and finally 16 months after baseline T3 Data collection includes caregiver online surveys caregiver and child Zoom recorded Family Interaction Task conversations and interviewer administered child surveys for children aged 8-12 at each time point Standardized reliable and valid measures in the four languages will be used to assess change in outcomes through the surveys Longitudinal growth curve analysis will be used to test PIM intervention effects Our extensive dissemination plan involves nationwide community partners in child welfare and services to forcibly displaced families
The primary objective of this study is to conduct a summative impact evaluation of the PIM online parenting program as an in-home parent skill-based program for parents of school-aged children using a randomized controlled trial research design with community partnerships that inform the research throughout The longer-term objectives are to build the evidence-base for in-home parent skill-based programs with strong empirical support ie eligible for listing on the Families First Clearinghouse and increase access to parenting programs for forcibly displaced families thereby improving child safety and wellbeing and strengthening their public health support
720 families will be recruited with forced migration backgrounds and within 10 years of arrival in the USA 360 families will be assigned to the PIMonline program and 360 to a family resource list only wait-list control group Families will be recruited using stratified random sampling within the four PIM language groups English Spanish Arabic French Within each language half the families will be assigned to the PIMonline intervention program and the other half will be assigned to receiving a Family Resource List with access to the PIMonline program once the study ends
One parent and one child per eligible family may participate Data collection with participating families will take place at baseline T1 4-months after baseline T2 and finally 16 months after baseline T3 Data collection includes caregiver online surveys caregiver and child Zoom recorded Family Interaction Task conversations and interviewer administered child surveys for children aged 8-12 at each time point Standardized reliable and valid measures in the four languages will be used to assess change in outcomes through the surveys Longitudinal growth curve analysis will be used to test PIM intervention effects Our extensive dissemination plan involves nationwide community partners in child welfare and services to forcibly displaced families
Detailed Description:
Families may contact Study Personnel with any questions at any time All elements of this study are completed online or virtually over phonezoom conference
Recruitment efforts will be purposive and snowballing Recruitment efforts will take place through social media and word of mouth campaigns Communities will be reached out to broadly via word-of-mouth with electronic and printed flyers through the help of Community Advisory Board members community partners and other groups and organizations that provide direct interaction and services to immigrant and refugee populations in the US The project will also be advertised on the REACH Institute website at Arizona State University In addition to flyers video ads will also be used on social media platforms
Interested Caregivers will complete an online eligibility screening form to verify eligibility according to the specified criteria Caregivers who are ineligible will be thanked for their interest and provided with a Family Resource List If Caregivers meet criteria for inclusion on the screening form their information will be verified for authenticity In order to avoid enrollment of robots or false positive cases quality control measures will be carried out These include checking IP address the use of hidden questions that robots will respond to in efforts of identifying robots real humans cannot see these hidden questions but robots can validity questions eg child gender child DOB caregiver relationship for cross-comparing and checking validity of the datarespondent in addition to an open text box asking country of origin Any received forms suspected of being robots or possibly invalid will have a Study Staff member contact the family to verify authenticity of enrollment by reviewing some information provided in the eligibility screening form to ensure it is authentic input and not false or fabricated
Caregivers who are eligible and verified to be real will then receive a study welcome email with further information about the project and a link to a personalized consent form to sign electronically Upon signing the electronic consent form families will automatically move to the pretest survey The pretest survey asks a variety of questions that include demographics Parenting adjustment family values attitude trauma-related questions spirituality self-report of Parenting self-report of mental health and well-being and Caregiver reporting on Child mental and behavioral health problems
After the Caregiver Pretest survey is submitted a Study Staff member will contact the family to schedule Zoom recorded Family Interaction Task conversations between the Caregiver and Target Child and for children aged 8-12 the Target Childs survey which will be administered by Study Team Staff Child Assent will be recorded along with verifying Parent Permission for the Child to participate when the family is called for their scheduled Family Interaction Task conversation and Target Child survey
The Family Interaction Task conversation activities ask the Caregiver and Target Child to have two conversations 1 about problem solving problems that may be stressful for Parents and kids and 2 about the migration experience things the Child might be experiencing following migrating to the US
The Target Child survey asks the Child questions related to the Childs mental and behavioral health as well as some trauma-related questions
After all pretest data collection Baseline Caregiver survey Family Interaction Tasks and Target Child survey is completed the Caregiver is randomized to either a the intervention condition or b the waitlist control condition
Caregivers assigned to the intervention condition will receive a welcome email with a Family Resource List and instructions on how to start the Parenting in the Moment online program
Caregivers assigned to the waitlist control condition will receive an email with a Family Resource List
Caregiver surveys Family Interaction Tasks and Child surveys take place at times 0- baseline 4 months-posttest and 16 months posttest
After intervention families complete the PIMonline Parenting program they will provide Course Feedback and receive a Certificate of Completion
After the study period ends the waitlist control group will be emailed instructions on how to access the PIMonline program
Study instrument codebooks for each survey and the coding of Family Interaction Tasks detailing descriptions of each variable used including the source of the variable coding information and ranges if relevant will be saved and stored for reference
Primary objectives will be analyzed using linear growth curves with three waves of survey scores
Descriptive statistics ANOVA and crosstabs to examine the reach of social media and other recruitment strategies will be used And descriptive statistics will be used to report participation and satisfaction
To manage data a secure website and server maintaining stringent HIPAA-compliant levels of encryption and data storage and sophisticated data management and collection features will be employed The data manager will regularly download data from Redcap to check for errors duplicates and missing information Data will be cleaned scored and stored in SPSS or Excel formats Confidentiality is addressed by removing personal identifiers from database files and restricting access authorization to a specific set of project personnel only Databases generated for analysis will be de-identified prior to analysis
Recruitment efforts will be purposive and snowballing Recruitment efforts will take place through social media and word of mouth campaigns Communities will be reached out to broadly via word-of-mouth with electronic and printed flyers through the help of Community Advisory Board members community partners and other groups and organizations that provide direct interaction and services to immigrant and refugee populations in the US The project will also be advertised on the REACH Institute website at Arizona State University In addition to flyers video ads will also be used on social media platforms
Interested Caregivers will complete an online eligibility screening form to verify eligibility according to the specified criteria Caregivers who are ineligible will be thanked for their interest and provided with a Family Resource List If Caregivers meet criteria for inclusion on the screening form their information will be verified for authenticity In order to avoid enrollment of robots or false positive cases quality control measures will be carried out These include checking IP address the use of hidden questions that robots will respond to in efforts of identifying robots real humans cannot see these hidden questions but robots can validity questions eg child gender child DOB caregiver relationship for cross-comparing and checking validity of the datarespondent in addition to an open text box asking country of origin Any received forms suspected of being robots or possibly invalid will have a Study Staff member contact the family to verify authenticity of enrollment by reviewing some information provided in the eligibility screening form to ensure it is authentic input and not false or fabricated
Caregivers who are eligible and verified to be real will then receive a study welcome email with further information about the project and a link to a personalized consent form to sign electronically Upon signing the electronic consent form families will automatically move to the pretest survey The pretest survey asks a variety of questions that include demographics Parenting adjustment family values attitude trauma-related questions spirituality self-report of Parenting self-report of mental health and well-being and Caregiver reporting on Child mental and behavioral health problems
After the Caregiver Pretest survey is submitted a Study Staff member will contact the family to schedule Zoom recorded Family Interaction Task conversations between the Caregiver and Target Child and for children aged 8-12 the Target Childs survey which will be administered by Study Team Staff Child Assent will be recorded along with verifying Parent Permission for the Child to participate when the family is called for their scheduled Family Interaction Task conversation and Target Child survey
The Family Interaction Task conversation activities ask the Caregiver and Target Child to have two conversations 1 about problem solving problems that may be stressful for Parents and kids and 2 about the migration experience things the Child might be experiencing following migrating to the US
The Target Child survey asks the Child questions related to the Childs mental and behavioral health as well as some trauma-related questions
After all pretest data collection Baseline Caregiver survey Family Interaction Tasks and Target Child survey is completed the Caregiver is randomized to either a the intervention condition or b the waitlist control condition
Caregivers assigned to the intervention condition will receive a welcome email with a Family Resource List and instructions on how to start the Parenting in the Moment online program
Caregivers assigned to the waitlist control condition will receive an email with a Family Resource List
Caregiver surveys Family Interaction Tasks and Child surveys take place at times 0- baseline 4 months-posttest and 16 months posttest
After intervention families complete the PIMonline Parenting program they will provide Course Feedback and receive a Certificate of Completion
After the study period ends the waitlist control group will be emailed instructions on how to access the PIMonline program
Study instrument codebooks for each survey and the coding of Family Interaction Tasks detailing descriptions of each variable used including the source of the variable coding information and ranges if relevant will be saved and stored for reference
Primary objectives will be analyzed using linear growth curves with three waves of survey scores
Descriptive statistics ANOVA and crosstabs to examine the reach of social media and other recruitment strategies will be used And descriptive statistics will be used to report participation and satisfaction
To manage data a secure website and server maintaining stringent HIPAA-compliant levels of encryption and data storage and sophisticated data management and collection features will be employed The data manager will regularly download data from Redcap to check for errors duplicates and missing information Data will be cleaned scored and stored in SPSS or Excel formats Confidentiality is addressed by removing personal identifiers from database files and restricting access authorization to a specific set of project personnel only Databases generated for analysis will be de-identified prior to analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None