Parenting in 2 Worlds Multisite Trial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorArizona State University
About this trial
This research study will test the effectiveness of a culturally grounded parenting intervention called Parenting in 2 Worlds (P2W). This intervention is designed for American Indian / Alaska Native (AI) parents/guardians of adolescents who reside in urban areas. This will be a multi-regional effectiveness trial across four regions: Northeast (Buffalo/Niagara), Midwest (St. Paul/Minneapolis), Mountain (Denver), and Southwest (Phoenix). There are four specific aims. First, this study will test the effectiveness of Parenting in Two Worlds (P2W) as compared to an informational family health intervention, Healthy Families in 2 Worlds (HF2W), in improving parenting and family functioning. Second, this study will test if the relative effectiveness of P2W, compared to HF2W, varies by parent's/guardian's level of socioeconomic vulnerability, experiences of historical loss, or AI cultural identity. Third, this study will examine if P2W can reduce adolescent (ages 12 - 17) risky health behaviors including substance use, depressive symptoms, suicidality, and risky sexual behaviors. Fourth, this study will examine whether positive changes in parenting and family functioning that result from P2W lead to positive changes in adolescent's health behaviors.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Must be American Indian parents or guardians of American Indian children aged 12 to 17 who attend urban schools
Must reside in the service areas of the four urban Indian centers who are participating in this study
Self-identifies as American Indian
Must be primary caregiver responsible for day-to-day decisions for an American Indian child ages 12 to 17
Disqualifiers
Not applicable
Trial design
Design model
Parallel
Treatments tested in this trial
Parenting in 2 Worlds (P2W)
BehavioralP2W is a culturally-adapted parenting intervention designed specifically for urban American Indian families. It is a 10-week, 10-lesson manualized curriculum with accompanying videos, designed to be facilitated by American Indians from the local communities. The workshop lessons cover topics like the identification of family values, culturally influenced child rearing values and traditions, sources of support for parents, and ways to improve parenting skills to communicate with, monitor, and guide adolescents to avoid substance use, unprotected sex and other risk behaviors
Healthy Families in 2 Worlds (HF2W)
BehavioralHF2W is a 10-week informational family health program. The workshop lessons cover topics such as oral health, CPR and first aid, dating safety, and teen mental health.
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: Parenting in 2 Worlds (treatment)Experimental treatment 1 intervention
Group B: Healthy Families in 2 WorldsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in family functioning and cohesion
Caregiver and adolescent self-report about supportiveness, closeness, togetherness and cooperation among family members. Scale: Minimum = 1 and Maximum = 5 \[1 = Almost never, 2 = Once in a while, 3 = Sometimes, 4 = Frequently, 5 = Almost always\]. Higher is better outcome.
Time frame
10 week and 12 month follow up2
Change from baseline in parental involvement
Caregiver and adolescent self-report about caregiver's involvement in adolescent's daily activities. Scale: Minimum = 1 and Maximum = 4 \[1 = More than 1 month ago, 2 = Within the last month, 3 = Within the last week, 4 = Yesterday or today\]. Higher is better outcome.
Time frame
10 week and 12 month follow up3
Change from baseline in parental supervision
Caregiver and adolescent self-report about caregiver's direct supervision such as established curfews. Scale: Minimum = 1 and Maximum = 5 \[1 = Almost never, 2 = Once in a while, 3 = Sometimes, 4 = Frequently, 5 = Almost always\]. Higher is better outcome.
Time frame
10 week and 12 month follow up4
Change from baseline in parental monitoring
Caregiver and adolescent self-report about caregiver's knowledge of adolescent's activities, friends and whereabouts. Scale: Minimum = 1 and Maximum = 5 \[1 = Almost never, 2 = Once in a while, 3 = Sometimes, 4 = Frequently, 5 = Almost always\]. Higher is better outcome.
Time frame
10 week and 12 month follow upSecondary outcomes
1
Change from baseline in depressive symptoms
Adolescent self-reports about their symptoms of depression like feeling sad. Scale: Minimum = 1 and Maximum = 4 \[1 = Rarely or none of them time (less than 1 day), 2 = Some or a little of the time (1 - 2 days), 3 = Occasionally or a moderate amount of time (3 - 4 days), 4 = All of the time (5 - 7 days)\]. Higher is worse outcome.
Time frame
10 week and 12 month follow up2
Change from baseline in suicidality
Adolescent self-reports about their suicidal ideation and behavior. Scale: Minimum = 0 and Maximum = 4 \[0 = Never, 1 = Once, 2 = 1 - 2 times a week, 3 = 3 - 4 times a week, 4 = Daily\]. Higher is worse outcome.
Time frame
10 week and 12 month follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Arizona State University
Lead sponsor
Phoenix Indian Center
Collaborator
Ain Dah Yung Center
Collaborator
Denver Indian Center Inc
Collaborator
Native American Community Services of Erie and Niagara Counties
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov