Evaluation of the Parenting in the Moment Online Program for Forcibly Displaced Families
NCT Number: NCT06548126
Acronym: PIMonline
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Child Safety|Coercion|Child Wellbeing|Adjustment|Parenting|Post Traumatic Stress Disorder|Mental Health|Child Maltreatment|Trauma|Emotional Regulation
Interventions: BEHAVIORAL: Online Parenting Program|OTHER: No online parenting program
Sponsor: Arizona State University
Collaborators: Department of Health and Human Services
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 720
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-12
Completion Date: 2026-06-15
Locations: Arizona State University, Tempe, Arizona, 85287, United States

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 (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.

Primary Outcome Measures: Child Safety, 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), 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)|Child Safety, 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), 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)|Child Wellbeing, 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), 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)|Child Wellbeing, 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)., 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)|Child Wellbeing, 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)., 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)|Child Wellbeing, 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., 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)|Adult Wellbeing, 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)., 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)|Adult Wellbeing, 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., 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)|Adult Wellbeing, 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)., 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)|Adult Wellbeing, 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., 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)|Covariates and control variables, 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., 0-Baseline (timepoint 1)|Caregiver Satisfaction with the intervention, Descriptive statistics and a Parenting in the Moment acceptability and feasibility survey., 4-month Posttest (timepoint 2)|Emotion Coaching, 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., 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)|Problem Solving, 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., 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)
Secondary Outcome Measures: Adult Wellbeing secondary outcomes, 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: Difficulties in Emotion Regulation Scale (DERS)., 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)|Adult Wellbeing secondary outcomes, 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: Coping with Negative Emotions Scale (CCNES)., 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)