NCT06548126 · Arizona State University
Evaluation of the Parenting in the Moment Online Program for Forcibly Displaced Families
(PIMonline)
What this study is about
This randomly assigned Controlled Trial will test the effectiveness of the Parenting in the Moment (PIM) online parenting program for parents with experiences of forced displacement.
View original scientific description
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 (i.e., 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.
Interventions
BEHAVIORAL
Online Parenting Program
Online Parenting Program comprised of 12 online modules. Caregivers do one module per week for 12-15 weeks; each unit takes about 20 minutes to do. The Caregiver also practices the tools they learn for Parenting their Children between sessions.
OTHER
No online parenting program
List of Parenting resources.
Primary outcome measures
Child Safety
Time frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)
Structural equation modeling (SEM) growth curve analyses on child outcomes will be employed. The following evidence-based measures will be used to measure change and determine child safety outcomes as a result of the intervention: Child Abuse Screening Tool (ICAST-T attitudes to punishment scale)
Child Safety
Time frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)
Structural equation modeling (SEM) growth curve analyses on child outcomes will be employed. The following evidence-based measures will be used to measure change and determine child safety outcomes as a result of the intervention: UNICEF (Multiple Indicator Cluster Survey (MIC5)
Child Wellbeing
Time frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)
Structural equation modeling (SEM) growth curve analyses on child outcomes will be employed. The following evidence-based measures will be used to measure change and determine child safety outcomes as a result of the intervention: Parent report on child - Eyberg Child Behavior Inventory (ECBI)
Child Wellbeing
Time frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)
Structural equation modeling (SEM) growth curve analyses on child outcomes will be employed. The following evidence-based measures will be used to measure change and determine child safety outcomes as a result of the intervention: Parent report on child - Revised Child Anxiety and Depression Scale (RCADS).
Child Wellbeing
Time frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)
For child wellbeing this is what it reads: Structural equation modeling (SEM) growth curve analyses on child outcomes will be employed. The following evidence-based measures will be used to measure change and determine child safety outcomes as a result of the intervention: Child report on self- Revised Child Anxiety and Depression Scale (RCADS).
Child Wellbeing
Time frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)
For child wellbeing this is what it reads: Structural equation modeling (SEM) growth curve analyses on child outcomes will be employed. The following evidence-based measures will be used to measure change and determine child safety outcomes as a result of the intervention: Child report on self- UCLA Child Trauma plus PTSD.
Adult Wellbeing
Time frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)
Structural equation modeling (SEM) growth curve analyses on Caregiver outcomes will be employed. The following evidence-based measures will be used to measure change and determine adult wellbeing outcomes as a result of the intervention: Parent Locus of Control (PLOC-SFR).
Adult Wellbeing
Time frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)
Structural equation modeling (SEM) growth curve analyses on Caregiver outcomes will be employed. The following evidence-based measures will be used to measure change and determine adult wellbeing outcomes as a result of the intervention: Patient Health Questionnaire (HTQ, Diagnostic and Statistical Manual-5) PTSD Events.
Adult Wellbeing
Time frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)
Structural equation modeling (SEM) growth curve analyses on Caregiver outcomes will be employed. The following evidence-based measures will be used to measure change and determine adult wellbeing outcomes as a result of the intervention: World Health Organization (WHO5).
Adult Wellbeing
Time frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)
Structural equation modeling (SEM) growth curve analyses on Caregiver outcomes will be employed. The following evidence-based measures will be used to measure change and determine adult wellbeing outcomes as a result of the intervention: Harvard Trauma Questionnaire (HTQ-5) Trauma Events.
Covariates and control variables
Time frame: 0-Baseline (timepoint 1)
Demographics measure to include: gender, age, racial and ethnic identity of caregivers and children; language(s) spoken; education, employment, income, and information about the migration experience, including countries of origin, reasons for fleeing.
Caregiver Satisfaction with the intervention
Time frame: 4-month Posttest (timepoint 2)
Descriptive statistics and a Parenting in the Moment acceptability and feasibility survey.
Emotion Coaching
Time frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)
Observational Coder ratings will yield reliable and valid measures of parenting practices with short- and long-term predictive validity for child and parent outcomes. Rating will yield the primary construct: emotion socialization. Scale scores yield reliable Cronbach alphas (ranging from .74-.92) and interrater reliabilities in the 70-80% range.
Problem Solving
Time frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)
Observational Coder ratings will yield reliable and valid measures of parenting practices with short- and long-term predictive validity for child and parent outcomes. Rating will yield the primary construct: positive parenting (family problem-solving, skill encouragement, positive involvement, monitoring). Scale scores yield reliable Cronbach alphas (ranging from .74-.92) and interrater reliabilities in the 70-80% range.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- The person is a primary Caregiver to a Child age 6 - 12 years in their care and living with them at least half the time
- The Caregiver is at least 18 years of age
- The Caregiver is able to do a program delivered in English, Spanish, Arabic or French, and to answer questions in English, Spanish, Arabic or French.
- The Caregiver resides in the United States
- The Caregiver has reliable access to a smart phone, tablet, or computer with stable internet access.
- One Parent, not necessarily the PCG, has experienced forced displacement in the past 10 years
- The Parent is able to consent for self and Child If the PCG does not have the legal right to provide Parent permission for the Child to participate, the Child's legal Parent/Caregiver can provide consent while the PCG actively participates in the study with the Child.
- The Child is able to answer questions in English, Spanish, Arabic or French.
Exclusion criteria
- Impaired decision-making capacity
- Disclosed active psychosis of Parent or Child
- Open Child protection case for abuse or neglect in the family
Where
- Tempe, Arizona
Collaborators
Department of Health and Human Services
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 19, 2024 · Source of record for eligibility and locations