Trial Outcomes & Findings for Family Listening Program: Multi-Tribal Implementation and Evaluation (NCT NCT03142009)

Results Overview

Self-report measures of anxiety, Anxiety Panic/GAD Sub-Scale, average change from baseline (pre-program participation). Anxiety Items coded are coded 1-4. The scale was calculated as the arithmetic average of items, which results in a minimum value of 1 and a maximum value of 4. Lower scores are better. The Panic/GAD sub-scale was the average of three items with the same min/max as the full scale. Children surveyed at pre-test, post-test (2-4 months after intervention), and one-year post intervention.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

266 participants

Primary outcome timeframe

post-test (2-4 months after intervention)

Results posted on

2025-02-03

Participant Flow

Recruitment of children participants occurred in three tribal communities: Ramah Navajo, Mescalero Apache Tribe, and Pueblo of Jemez. UNM Health Sciences Human Research Protections Office (HRPO) approved recruitment from 2014 for up to 12 families (typically one child and one caregiver) from each tribal community for the full five years of the study, with the official closing of the IRB on Feb 6, 2021. Tribes recruited students from different schools in their communities. Parents not analyzed

Participant milestones

Participant milestones
Measure	Program Group Tribal Research Team members recruit participants by sending letters home with the fourth and fifth grade children. This letter provides an overview of the FL/CP and invite interested parents and children to learn more. TRT and UNM team members follow-up with interested parents individually. If families are committed to being a part of FL/CP, a meeting is set to conduct the informed consent process and complete pretest. Families in the program group then attend FL/CP sessions which covers the intergenerational culturally adapted curriculum. Program families also participate in various aspects of the program including completing a Community Action Project. Intergenerational culturally adapted curriculum: Each session starts with a collective dinner with families eating together. Then practice their Indian and clan names. The sessions are led by facilitators in their own language or bilingually. The facilitators then divide the families into children and adult groups to address the theme of the session, and they then return together at the end of the session to share their learnings. The sessions always end with the children and adults writing in their journals which are individual pages that they then put in their curriculum binders. Families are then given their "home practice," which is a task that the families do together during the intervening week. The facilitators collect the curriculum binders after each session to bring back to the families the next week.	Comparison Group Upon receiving the letter families that selected not to participate or who decline to participate will be invited to take part in the research study as comparison participants. Comparison participants do not attend the FL/CP sessions and only complete the pre, post and 1 year post tests.
Overall Study STARTED	138	128
Overall Study COMPLETED	93	98
Overall Study NOT COMPLETED	45	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Program Group Tribal Research Team members recruit participants by sending letters home with the fourth and fifth grade children. This letter provides an overview of the FL/CP and invite interested parents and children to learn more. TRT and UNM team members follow-up with interested parents individually. If families are committed to being a part of FL/CP, a meeting is set to conduct the informed consent process and complete pretest. Families in the program group then attend FL/CP sessions which covers the intergenerational culturally adapted curriculum. Program families also participate in various aspects of the program including completing a Community Action Project. Intergenerational culturally adapted curriculum: Each session starts with a collective dinner with families eating together. Then practice their Indian and clan names. The sessions are led by facilitators in their own language or bilingually. The facilitators then divide the families into children and adult groups to address the theme of the session, and they then return together at the end of the session to share their learnings. The sessions always end with the children and adults writing in their journals which are individual pages that they then put in their curriculum binders. Families are then given their "home practice," which is a task that the families do together during the intervening week. The facilitators collect the curriculum binders after each session to bring back to the families the next week.	Comparison Group Upon receiving the letter families that selected not to participate or who decline to participate will be invited to take part in the research study as comparison participants. Comparison participants do not attend the FL/CP sessions and only complete the pre, post and 1 year post tests.
Overall Study Lost to Follow-up	45	30

Baseline Characteristics

Family Listening Program: Multi-Tribal Implementation and Evaluation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Program Group n=138 Participants Tribal Research Team members recruit participants by sending letters home with the fourth and fifth grade children. This letter provides an overview of the FL/CP and invite interested parents and children to learn more. TRT and UNM team members follow-up with interested parents individually. If families are committed to being a part of FL/CP, a meeting is set to conduct the informed consent process and complete pretest. Families in the program group then attend FL/CP sessions which covers the intergenerational culturally adapted curriculum. Program families also participate in various aspects of the program including completing a Community Action Project. Intergenerational culturally adapted curriculum: Each session starts with a collective dinner with families eating together. Then practice their Indian and clan names. The sessions are led by facilitators in their own language or bilingually. The facilitators then divide the families into children and adult groups to address the theme of the session, and they then return together at the end of the session to share their learnings. The sessions always end with the children and adults writing in their journals which are individual pages that they then put in their curriculum binders. Families are then given their "home practice," which is a task that the families do together during the intervening week. The facilitators collect the curriculum binders after each session to bring back to the families the next week.	Comparison Group n=128 Participants Upon receiving the letter families that selected not to participate or who decline to participate will be invited to take part in the research study as comparison participants. Comparison participants do not attend the FL/CP sessions and only complete the pre, post and 1 year post tests.	Total n=266 Participants Total of all reporting groups
Age, Continuous	10 years n=5 Participants	10 years n=7 Participants	10 years n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	69 Participants n=7 Participants	140 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	59 Participants n=7 Participants	126 Participants n=5 Participants
Race/Ethnicity, Customized Tribal members	138 Participants n=5 Participants	128 Participants n=7 Participants	266 Participants n=5 Participants
Region of Enrollment United States	138 participants n=5 Participants	128 participants n=7 Participants	266 participants n=5 Participants
Depression	2.63 units on a scale STANDARD_DEVIATION 0.25 • n=5 Participants	2.71 units on a scale STANDARD_DEVIATION 0.23 • n=7 Participants	2.67 units on a scale STANDARD_DEVIATION 0.24 • n=5 Participants

PRIMARY outcome

Timeframe: post-test (2-4 months after intervention)

Population: Children age 10-12 recruited from three different tribal communities, with program families recruited from children in schools, with program families agreeing to participate and families who did not participate allocated to comparison group. 4 intervention children and 2 comparison children did not complete post-survey (2-4 months). Because this average looks at the difference in mean change between two arms, therefore negative means are possible. This represents a change that is favorable.

Self-report measures of anxiety, Anxiety Panic/GAD Sub-Scale, average change from baseline (pre-program participation). Anxiety Items coded are coded 1-4. The scale was calculated as the arithmetic average of items, which results in a minimum value of 1 and a maximum value of 4. Lower scores are better. The Panic/GAD sub-scale was the average of three items with the same min/max as the full scale. Children surveyed at pre-test, post-test (2-4 months after intervention), and one-year post intervention.

Outcome measures

Outcome measures
Measure	Program Group n=134 Participants Tribal Research Team members recruit participants by sending letters home with the fourth and fifth grade children. This letter provides an overview of the FL/CP and invite interested parents and children to learn more. TRT and UNM team members follow-up with interested parents individually. If families are committed to being a part of FL/CP, a meeting is set to conduct the informed consent process and complete pretest. Families in the program group then attend FL/CP sessions which covers the intergenerational culturally adapted curriculum. Program families also participate in various aspects of the program including completing a Community Action Project. Intergenerational culturally adapted curriculum: Each session starts with a collective dinner with families eating together. Then practice their Indian and clan names. The sessions are led by facilitators in their own language or bilingually. The facilitators then divide the families into children and adult groups to address the theme of the session, and they then return together at the end of the session to share their learnings. The sessions always end with the children and adults writing in their journals which are individual pages that they then put in their curriculum binders. Families are then given their "home practice," which is a task that the families do together during the intervening week. The facilitators collect the curriculum binders after each session to bring back to the families the next week.	Comparison Group n=126 Participants Upon receiving the letter families that selected not to participate or who decline to participate will be invited to take part in the research study as comparison participants. Comparison participants do not attend the FL/CP sessions and only complete the pre, post and 1 year post tests.
Child Well-being	-0.20 units on a scale Interval -0.34 to -0.05	0.05 units on a scale Interval -0.1 to 0.2

SECONDARY outcome

Timeframe: Post-post survey: One year after the intervention

Population: Children ages 10-12 from three tribal communities that included children with their family caregiver who were recruited in schools. Children who responded were recruited into program group. Children who did not respond to participate in the program were allocated to comparison group. Some children did not have valid depression scale data.

Self-report measures of depression, change from baseline at one-year, Depression scale items were coded 1 to 3, and the arithmetic mean of 26 items was used to compute the scale. The scale has a minimum of 1.0 and a maximum of 3.0 with higher values be better, i.e. lower levels of depression.

Outcome measures

Outcome measures
Measure	Program Group n=137 Participants Tribal Research Team members recruit participants by sending letters home with the fourth and fifth grade children. This letter provides an overview of the FL/CP and invite interested parents and children to learn more. TRT and UNM team members follow-up with interested parents individually. If families are committed to being a part of FL/CP, a meeting is set to conduct the informed consent process and complete pretest. Families in the program group then attend FL/CP sessions which covers the intergenerational culturally adapted curriculum. Program families also participate in various aspects of the program including completing a Community Action Project. Intergenerational culturally adapted curriculum: Each session starts with a collective dinner with families eating together. Then practice their Indian and clan names. The sessions are led by facilitators in their own language or bilingually. The facilitators then divide the families into children and adult groups to address the theme of the session, and they then return together at the end of the session to share their learnings. The sessions always end with the children and adults writing in their journals which are individual pages that they then put in their curriculum binders. Families are then given their "home practice," which is a task that the families do together during the intervening week. The facilitators collect the curriculum binders after each session to bring back to the families the next week.	Comparison Group n=127 Participants Upon receiving the letter families that selected not to participate or who decline to participate will be invited to take part in the research study as comparison participants. Comparison participants do not attend the FL/CP sessions and only complete the pre, post and 1 year post tests.
Child Well-being	0.06 change in units on scale Interval 0.01 to 0.11	-0.01 change in units on scale Interval -0.07 to 0.05

Adverse Events

Program and Comparison Groups

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nina Wallerstein

University of New Mexico College of Population Health

Phone: 404-272-4173

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place