Introduction
Background and rationale
Objectives
Methods
Conceptual model
Trial design
Study setting
Participants
Eligibility criteria
Recruitment and consent/assent
Intervention
Component | Origin | Participant(s) |
---|---|---|
Psychoeducation | CETA | Parent |
Substance Use Prevention | CETA | Parent |
Coping with Traumatic Stress Symptoms | CETA | Parent |
Cognitive Coping Skills | CETA | Parent |
Knowing Your Child | Family Spirit | Parent |
Monitoring Your Child | Family Spirit | Parent |
Daily Routines | Family Spirit | Parent |
Skills for Healthy Living | Family Spirit | Parent |
Promoting Tribal Identity | Cultural | Parent + Child |
Enhancing Communal Mastery | Cultural | Parent + Child |
Promoting Smudging | Cultural | Parent + Child |
Healing Historical & Contemporary Trauma | Cultural | Parent |
Control condition
Week | Little Holy One Lessons (Intervention) | Nutrition Lessons (Control) |
---|---|---|
1 | Ą́ba Wasté / Aŋpétu Wašté (Promoting Tribal Identity) | Racing Towards Healthy Eating |
2 | Understanding our Emotions | – |
3 | Azí’įc’iya / Azídya (Promoting Smudging) | Fun with Food Groups! |
4 | Thinking Positively | – |
5 | Encouraging Early Learning | Portion Sizes |
6 | Daily Routines for Caregivers and their Children | – |
7 | Alcohol and Drug Use | Making Your Plate |
8 | Monitoring your Child’s Routine | – |
9 | Strengthening Family and Community (Enhancing Communal Mastery) | Rethink Your Drink! |
10 | The Power of Our Memories | – |
11 | Healing Historical Trauma | Savor It: Smell, See, Taste! |
12 | Skills for Effective Caregiving | – |
Lesson frequency and duration
Randomization process and study flow
Allocation, concealment, and implementation
Measures
# of items | Baseline | Pre-session 1 | Each session | 6 weeks | 12 weeks | 6 months | 12 months | 18 months | 24 months | |
---|---|---|---|---|---|---|---|---|---|---|
AIM 1 | ||||||||||
CAREGIVER: Mental/Emotional | ||||||||||
PTSD Checklist for DSM-5 | 13 | x | x | x | x | x | x | x | ||
Parenting Stress Index - Short Form | 20 | x | x | x | x | x | x | x | ||
Stressful Life Events Questionnaire | 13 | x | ||||||||
CESD-R-10 | 10 | x | x | x | x | |||||
Benevolent Childhood Experiences | 10 | x | ||||||||
Adverse Childhood Experiences | 17 | x | ||||||||
CAREGIVER: Physical | ||||||||||
Parenting Practices Interview | 72 | x | x | x | x | |||||
Parental Locus of Control | 47 | x | x | x | x | |||||
Family Routines Index | 28 | x | x | x | x | |||||
WHO ASSIST | 10 | x | x | x | x | |||||
CAREGIVER: Spiritual | ||||||||||
Historical Trauma | 3 | x | ||||||||
Historical Loss Scale | 12 | x | ||||||||
Communal Mastery Scale | 10 | x | x | x | x | |||||
Orthogonal Cultural Identification Scale | 6 | x | x | x | x | |||||
Historical Trauma Checklist | 16 | x | ||||||||
CHILD: Mental/Emotional | ||||||||||
Strengths and Difficulties Questionnaire | 30 | x | x | x | x | |||||
CHILD: Physical | ||||||||||
School Attendance | – | x | x | x | x | x | x | x | ||
AIM 2 | ||||||||||
Perceived Stress Scale | 10 | x | x | x | x | x | x | x | x | |
AIM 3: SOCIAL NETWORKS SUPPLEMENT | ||||||||||
Caregiver Ego Networks | 17 | x | x | x | x | |||||
Columbia Suicide Severity Rating Scale | 6 | x | x | x | x |
Sample size and power
Aim 1
N | α | Power (1-β) | Effect size (f) | |
---|---|---|---|---|
Aim 1 | ||||
Parents | 120 | 0.05 | 0.80 | 0.13 |
Children | 120 | 0.05 | 0.80 | 0.13 |
24-month outcomes | ||||
Parents | 84 | 0.05 | 0.80 | 0.20 |
Children | 84 | 0.05 | 0.80 | 0.20 |
Aim 2 | ||||
Parents | 60 | 0.05 | 0.80 | 0.20 |
Additional moderator exploration | ||||
Gender (Child outcomes) | 60 | 0.05 | 0.80 | 0.24 |
Age (Child outcomes) | 60 | 0.05 | 0.80 | 0.24 |
Type of caregiver (Parent and child outcomes) | 60 | 0.05 | 0.80 | 0.24 |