Evaluation of the Parenting in the Moment Online Program for Forcibly Displaced Families

NCT06548126 | Recruiting

• 1 other identifier: 90FA3009
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Child Safety; Coercion; Child Wellbeing; Adjustment; Parenting; Post Traumatic Stress Disorder; Mental Health; Child Maltreatment; Trauma; Emotional Regulation

Keywords

Forced displacement; Refugees; Parenting Program; Immigrant Parenting Program; Refugee Parenting Program

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (2)

• Adult Wellbeing secondary outcomes

  0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)

• Adult Wellbeing secondary outcomes

  0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3)

Study Arms (2)

Parenting Intervention

EXPERIMENTAL

Participants will receive the PIMonline program and a list of Parenting resources.

Behavioral: Online Parenting Program

Control

PLACEBO COMPARATOR

Participants will receive a list of Parenting resources. Once the study period ends, they will be given access to the PIMonline program.

Other: No online parenting program

Interventions

Online Parenting Program BEHAVIORAL

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.

Also known as: PIMonline, PIM Treatment, Parenting in the Moment

Parenting Intervention

No online parenting program OTHER

List of Parenting resources.

Also known as: Control, Placebo

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Prisoners
• Impaired decision-making capacity
• Disclosed active psychosis of Parent or Child
• Open Child protection case for abuse or neglect in the family

Sponsors & Collaborators

• Arizona State University: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

Arizona State University

Tempe, Arizona, 85287, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Psychological Well-Being; Wounds and Injuries; Emotional Regulation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Personal Satisfaction; Behavior; Self-Control; Social Behavior

Study Officials

• Abigail Gewirtz, Ph.D.

  Arizona State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martha Project Manager, B.S.

CONTACT

480-965-5401; martha.serrano@asu.edu

Monique Operations Director, B.A.

CONTACT

480-965-7420; monique.lopez@asu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study Staff members involved with contacting families for scheduling purposes, administering the Family Interaction Tasks and administering Target Child surveys are prevented from having knowledge of individual participants' randomization assignment. The principle investigator and outcome assessor are also masked and prevented from having knowledge of individual participants' randomization assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director of REACH and Professor, Psychology

Model Details: Families will be recruited using stratified random sampling within the four PIM language groups; 180 families will be recruited from each (English, Spanish, French, Arabic), from which 90 families will be assigned to the intervention. This study will randomly select intervention and control families as they enter the study following a 1:1 randomization scheme.

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: August 12, 2024
• Study Start: September 12, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)