N/A
Completed N=74
Piloting +Connection is Medicine / The Healing Spirits Program
Mental Health Issue · Depressive Symptoms · Anxiety
Source: ClinicalTrials.gov NCT05424679 ↗
Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Group Differences in Mean Scores for Caregiver and Youth General Distress Over Time as Assessed by the Kessler Psychological Distress Scale — 8.56; 8.69; 6.52; 8.0 score on scale
Summary
This study aims to assess what benefit, if any, an individualized coping plan and facilitating connections to care through referral coordination in conjunction with culturally tailored caring messages, (herein called the +Connection is Medicine intervention (Navajo Nation study name; +CiM)/The Healing Spirits Program (White Mountain Apache Tribe Study Name; HSP) have on the mental health of American Indian (AI) youth and caregivers who were previously identified as having high levels of anxiety and depression as part of their participation in a cohort study called Project SafeSchools (NIH Grant No.: OT2HD107543).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Group Differences in Mean Scores for Caregiver and Youth General Distress Over Time as Assessed by the Kessler Psychological Distress Scale |
8.56; 8.69; 6.52; 8.0; 6.33; 7.19 | — |
| PRIMARY Group Differences in Mean Scores for Youth Emotional Problems Over Time as Assessed by the Strengths and Difficulties Questionnaire |
5.75; 5.0; 1.67; 4.33; 3.0; 4.5 | — |
| SECONDARY Group Differences in Mean Scores for Caregiver and Youth Depressive Symptoms Over Time as Assessed by the Center for Epidemiologic Studies Depression Scale-Revised-10 |
10.9; 12.8; 7.36; 10.4; 6.62; 9.74 | — |
| SECONDARY Group Differences in Mean Scores for Caregiver Anxiety Over Time as Assessed by the Patient-Reported Outcome Measurement Information System |
20.5; 20.6; 16.7; 18.3; 14.9; 15.8 | — |
| SECONDARY Group Differences in Mean Scores for Youth Anxiety Over Time as Assessed by the Screen for Child Anxiety Related Emotional Disorders |
23.8; 26.7; 9.0; 23.3; 12.5; 20.0 | — |
Eligibility Criteria
Inclusion Criteria
- All participants must be parents/caregivers or index youth enrolled in a cohort study called Project SafeSchools.
Adult participants
- Have elevated levels of mental distress as reported in a Project SafeSchools assessment.
- Agreement to be re-contacted for future research as part of their Project SafeSchools consent.
- Meeting symptom eligibility criteria at a screening assessment/baseline visit indicating mental distress.
Youth participants:
- Are 11-16 years old
- Agreement from parent/caregiver to be re-contacted for future research from their Project SafeSchools consent form.
- Meeting symptom eligibility criteria based on a self-report screening assessment/baseline visit indicating mental distress.
For the inclusion criteria, mental distress is defined as meeting eligibility cutoff scores on the following instruments:
Adult Participants
- General Distress (Kessler)
- Anxiety (PROMIS)
- Depression (CESDR-10)
- Recent Suicide Ideation (either CESDR-10 or Ideation Questionnaire)
Youth Participants:
- Depression (CESDR-10)
- Emotional Problems (SDQ Emotional Problems Subscale)
- Anxiety (SCARED)
- Recent Ideation (Ideation question on CESDR-10 or ideation questionnaire)
Exclusion Criteria
- Inability to cognitively complete interventions and assessments
Data sourced from ClinicalTrials.gov (NCT05424679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.