Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules for Parenting

Fort Peck Tribal Head Start, Poplar, MT
Parenting+2 More ConditionsNewly created cultural components, adapted Family Spirit lessons, adapted CETA modules - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will develop an intervention to help reduce historical trauma and stress among Native American caregivers and improve their children's emotional and behavioral development to reduce the risk for suicide and substance abuse.

Eligible Conditions
  • Parenting
  • Psychological Trauma
  • Suicide

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

4 Primary · 23 Secondary · Reporting Duration: Baseline, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months

At baseline visit, up to 15 minutes
Caregiver Substance Use as assessed by the adapted Centers for Disease Control Youth Risk Behavior Surveillance Survey
Baseline visit
Aim 1: Adverse Childhood Experiences (ACEs)
Aim 1: Parent historical loss experiences
Aim 1: Parental experiences related to historical trauma
Aim 1: Parents' positive childhood experiences
Aim 1: Stressful Life Events
Month 12
Aim 1: Change in Caregiver Depression
Aim 1: Family routines
Aim 1: Parent substance use
Aim 1: Parent tribal identity
Aim 1: Parental communal mastery
Aim 1: Parental control
Aim 1: Parenting practices
Aim 3: Social networks information
Aim 3: Suicide risk
Month 12
Aim 1: of child: child's externalization and internalization of symptoms
Month 12
Aim 1: of child: head start school attendance
Aim 1: Change in Caregiver Parenting Stress
Aim 1: Change in caregiver trauma symptoms
Aim 2: Parent stress
Month 24
Change in Child Internalizing and Externalizing symptoms as assessed by the Child Behavior Checklist
Month 24
Change in social networks of parents and caregivers as assessed by an adapted quantitative social networks measure
Month 12
Change in Caregiver Depression as assessed by the Center for Epidemiologic Studies Depression Scale-Revised
Change in Caregiver Parenting Practices as assessed by 72-item interview
Change in Caregiver Parenting Stress as assessed by the Parenting Stress Index - Short Form
Change in caregiver trauma symptoms as assessed by the PTSD Checklist for DSM-5
Week 12
Change in Caregiver Communal Mastery as assessed by 10-item questionnaire
Change in Caregiver Perceived Stress as assessed by the Perceived Stress Scale
Change in Caregiver Tribal Identity as assessed by the Orthogonal Cultural Identification Scale

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Nutrition control
1 of 2
Little Holy One intervention
1 of 2

Active Control

Experimental Treatment

120 Total Participants · 2 Treatment Groups

Primary Treatment: Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules · No Placebo Group · N/A

Little Holy One intervention
Behavioral
Experimental Group · 1 Intervention: Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules · Intervention Types: Behavioral
Nutrition control
Behavioral
ActiveComparator Group · 1 Intervention: Active nutrition control · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,616 Previous Clinical Trials
1,982,807 Total Patients Enrolled
6 Trials studying Parenting
846 Patients Enrolled for Parenting
Johns Hopkins UniversityLead Sponsor
2,115 Previous Clinical Trials
32,578,649 Total Patients Enrolled
1 Trials studying Parenting
250 Patients Enrolled for Parenting
Annie E. Casey FoundationOTHER_GOV
5 Previous Clinical Trials
1,520 Total Patients Enrolled
Teresa Brockie, PhDPrincipal InvestigatorJohns Hopkins University

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The parent or caregiver has experienced a traumatic event during their childhood or in the past.

Frequently Asked Questions

What aims are being sought to be achieved by this research endeavor?

"Across the specified timeline of Baseline, 6 weeks, 12 weeks, 6 months, 12 months 18 months and 24 months; this trial will measure Change in Caregiver Parenting Stress with the assistance of the Parenting Stress Index - Short Form. Other metrics include Change in Caregiver Perceived Stress as assessed via a 10-item questionnaire that ranges from 0 to 40 scores (with mean scores between 12-14) and no diagnostic or cut off score. Additionally, tribal identity is measured through Orthogonal Cultural Identification Scale's six questions about closeness to different cultures each accompanied by four answer choices ranging from 'A lot' to" - Anonymous Online Contributor

Unverified Answer

How many subjects are participating in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, the study is currently enrolling participants and was initially posted on November 18th 2019 with its most recent update released on November 15th 2022. The trial requires 120 individuals at one research site." - Anonymous Online Contributor

Unverified Answer

Are individuals still being accepted for enrollment in this experiment?

"Affirmative. Clinicaltrials.gov records demonstrate that this clinical trial is actively recruiting, having been first posted on November 18th 2019 and most recently updated on November 15th 2022. One site will be responsible for enrolling 120 participants in total." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.