Recruiting

Observational Study

Sponsor:

Arizona State University

Code:

NCT06548126

Conditions

Child Safety

Coercion

Child Wellbeing

Adjustment

Parenting

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Online Parenting Program

No online parenting program

Study Details

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

Study ID

NCT06548126

Start date

Sep 12, 2024

Status verified date

Aug, 2024

Completion date

Jun 15, 2026

Anticipated

Primary completion date

Jun 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 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
2. The Caregiver is at least 18 years of age
3. 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.
4. The Caregiver resides in the United States
5. The Caregiver has reliable access to a smart phone, tablet, or computer with stable internet access.
6. One Parent, not necessarily the PCG, has experienced forced displacement in the past 10 years
7. 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.
8. The Child is able to answer questions in English, Spanish, Arabic or French.

Exclusion Criteria:

1. Prisoners
2. Impaired decision-making capacity
3. Disclosed active psychosis of Parent or Child
4. Open Child protection case for abuse or neglect in the family

Study Design

Enrollment

720 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Parenting Intervention

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

placebo comparator: Control

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

Interventions

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.

No online parenting program

List of Parenting resources.

Primary outcome measure

  • Child Safety [ Time Frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3) ]
  • Child Safety [ Time Frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3) ]
  • Child Wellbeing [ Time Frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3) ]
  • Child Wellbeing [ Time Frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3) ]
  • Child Wellbeing [ Time Frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3) ]
  • Child Wellbeing [ Time Frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3) ]
  • Adult Wellbeing [ Time Frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3) ]
  • Adult Wellbeing [ Time Frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3) ]
  • Adult Wellbeing [ Time Frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3) ]
  • Adult Wellbeing [ Time Frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3) ]
  • Covariates and control variables [ Time Frame: 0-Baseline (timepoint 1) ]
  • Caregiver Satisfaction with the intervention [ Time Frame: 4-month Posttest (timepoint 2) ]
  • Emotion Coaching [ Time Frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3) ]
  • Problem Solving [ Time Frame: 0-Baseline (timepoint 1); 4-month Posttest (timepoint 2); 16-month Posttest (timepoint 3) ]

Central Contacts and Locations

Central contacts

Martha Project Manager, B.S.

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

Monique Operations Director, B.A.

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

Locations

Arizona State University

Recruiting

Tempe, Arizona, United States, 85287

Contacts

More Information

Sponsor

Arizona State University

Last update posted

Sep 19, 2024

Last verified

Aug, 2024

Keywords

  • Forced displacement
  • Refugees
  • Parenting Program
  • Immigrant Parenting Program
  • Refugee Parenting Program

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Arizona State University on 2024-09-19.