Depressive Symptoms, Quality of Life
Conditions
Keywords
adolescent, parent
Brief summary
This study evaluates the effectiveness of a novel depression self-management intervention in adolescents with depression.
Detailed description
Half of participants will receive a traditional depression self-management intervention, while the other half will receive the novel depression self-management intervention. In an exploratory, pilot 2-group randomized controlled trial (RCT), 16 adolescents were followed over 6 months. Data were collected at baseline, 3 months, and 6 months.
Interventions
BEHAVIORALTrust-building Self-management Together
Trust building plus depression self-management
BEHAVIORALDepression Management
Traditional depression self-management
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Lives in the Cleveland metro area * Ages 14-17 years old * Reports moderate depressive symptoms * Able to read, speak, and understand the English language
Exclusion criteria
* Current suicide risk * Diagnosis with bipolar disorder, schizophrenia, or a personality disorder * Severe behavioral problems that preclude group participation (as reported by parent) * Family plans to move from the region within 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-8 Adolescent | 3 months and 6 months post baseline | The Patient Health Questionnaire-8 (PHQ-8) Adolescent has 8 items scored on a 4 point Likert scale summed for a total score ranging from 0-24. Higher scores indicate greater levels of depressive symptoms with a score of 10 indicating a moderate level of depressive symptoms. The population mean = 5.6 (SD = 1.0). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Youth Quality of Life Scale | 3 and 6 months post baseline | The Youth Quality of Life Instrument-Short Form has 15 items measured on a 10 point Likert scale that are summed and t-scored, with higher scores indicating greater QoL. This is a continuously distributed scale without clinical cutoff scores. The quality of life mean t-score in the youth without depression (M= 81.0, SD= 11.7) is greater than the mean t-score in youth diagnosed with depression (M= 58.6, SD= 14.2). |
| Adolescent Sleep Hygiene Scale | 3 and 6 months post baseline | The Adolescent Sleep Hygiene Scale-revised has 8 subscales with 24 items scored on a 6 point Likert scale. Each subscale total is the mean of the items contained within. The mean of the subscale scores indicates the overall sleep score, with higher scores indicating greater sleep hygiene. The range is 1-6, with poor sleep hygiene indicated by the lowest quintile scores, which is ≤ 3.8 and good sleep hygiene is indicated by the highest quintile score, which is ≥ 4.9. |
| Stress Management | 3 and 6 months post baseline | The Adolescent Lifestyle Questionnaire Stress Management Subscale has four items on a 5 point Likert scale that are summed for a total score. The range is 5-20. Higher scores indicate greater stress management behavior. This is a continuously distributed scale without clinical cutoff scores. The population mean = 13.0 (SD = 3.6). |
| Medication Adherence | 3 and 6 months post baseline | The Extent of Non-Adherence Scale has 3 items measured on a 5-point Likert scale. A total score reflecting non-adherence is calculated by the mean of item responses, with a range of 1-5. Higher scores indicate greater levels of non-adherence and lower scores indicate greater adherence. The population mean = 1.8 (SD = 1.0). |
| Appointment Keeping | 3 and 6 months post baseline | The Hill-Bone Compliance Appointment Keeping Scale has 3 items measured on a four-point Likert scale. One item is reverse scored and then the three items are summed, resulting in a score ranging from 3-12. This is a continuously distributed scale without clinical cutoff scores. Lower scores indicate greater appointment keeping (M = 5.27 ± 0.93). |
Countries
United States
Participant flow
Recruitment details
We recruited in the community using flyers in Cleveland, Ohio from 2018-2020.
Pre-assignment details
All consented participants were assigned arms.
Participants by arm
| Arm | Count |
|---|---|
| Depression Management 8 weekly group sessions
Depression Management: Traditional depression self-management | 8 |
| Trust-building Self-management Together 8 weekly group sessions
Trust-building Self-management Together: Trust building plus depression self-management | 8 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 |
Baseline characteristics
| Characteristic | Depression Management | Trust-building Self-management Together | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 8 Participants | 8 Participants | 16 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14.75 years STANDARD_DEVIATION 0.31 | 15.13 years STANDARD_DEVIATION 0.35 | 14.94 years STANDARD_DEVIATION 0.23 |
| Appointment keeping | 5.40 units on a scale STANDARD_DEVIATION 1.81 | 6.20 units on a scale STANDARD_DEVIATION 2.95 | 5.80 units on a scale STANDARD_DEVIATION 2.35 |
| Depressive Symptoms | 13.75 units on a scale STANDARD_DEVIATION 4.03 | 12.63 units on a scale STANDARD_DEVIATION 2.07 | 13.19 units on a scale STANDARD_DEVIATION 3.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 7 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Medication adherence | 2.08 units on a scale STANDARD_DEVIATION 1.2 | 2.66 units on a scale STANDARD_DEVIATION 0.33 | 2.33 units on a scale STANDARD_DEVIATION 0.92 |
| Quality of Life | 54.75 T-score STANDARD_DEVIATION 11.7 | 58.33 T-score STANDARD_DEVIATION 13.59 | 56.54 T-score STANDARD_DEVIATION 12.39 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 3 Participants | 4 Participants |
| Region of Enrollment United States | 8 participants | 8 participants | 16 participants |
| Sex/Gender, Customized Female | 2 Participants | 5 Participants | 7 Participants |
| Sex/Gender, Customized Male | 5 Participants | 1 Participants | 6 Participants |
| Sex/Gender, Customized Transgender; Other, not specified | 1 Participants | 2 Participants | 3 Participants |
| Sleep | 4.22 units on a scale STANDARD_DEVIATION 0.85 | 4.19 units on a scale STANDARD_DEVIATION 0.52 | 4.20 units on a scale STANDARD_DEVIATION 0.67 |
| Stress management | 11.00 units on a scale STANDARD_DEVIATION 4.28 | 10.50 units on a scale STANDARD_DEVIATION 2.93 | 10.73 units on a scale STANDARD_DEVIATION 3.49 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Patient Health Questionnaire-8 Adolescent
The Patient Health Questionnaire-8 (PHQ-8) Adolescent has 8 items scored on a 4 point Likert scale summed for a total score ranging from 0-24. Higher scores indicate greater levels of depressive symptoms with a score of 10 indicating a moderate level of depressive symptoms. The population mean = 5.6 (SD = 1.0).
Time frame: 3 months and 6 months post baseline
Population: Using intent-to-treat principles, all participants were included in the analysis. However, four participants were lost to follow up at 6 months post baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Depression Management | Patient Health Questionnaire-8 Adolescent | 3 months post baseline | 6.17 units on a scale | Standard Deviation 1.33 |
| Depression Management | Patient Health Questionnaire-8 Adolescent | 6 months post baseline | 6.80 units on a scale | Standard Deviation 1.92 |
| Trust-building Self-management Together | Patient Health Questionnaire-8 Adolescent | 3 months post baseline | 9.43 units on a scale | Standard Deviation 6.32 |
| Trust-building Self-management Together | Patient Health Questionnaire-8 Adolescent | 6 months post baseline | 8.29 units on a scale | Standard Deviation 6.4 |
Secondary
Adolescent Sleep Hygiene Scale
The Adolescent Sleep Hygiene Scale-revised has 8 subscales with 24 items scored on a 6 point Likert scale. Each subscale total is the mean of the items contained within. The mean of the subscale scores indicates the overall sleep score, with higher scores indicating greater sleep hygiene. The range is 1-6, with poor sleep hygiene indicated by the lowest quintile scores, which is ≤ 3.8 and good sleep hygiene is indicated by the highest quintile score, which is ≥ 4.9.
Time frame: 3 and 6 months post baseline
Population: Using intent-to-treat principles, all participants were included in the analysis. However, four participants were lost to follow up at 6 months post baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Depression Management | Adolescent Sleep Hygiene Scale | 3 months post baseline | 4.63 units on a scale | Standard Deviation 0.62 |
| Depression Management | Adolescent Sleep Hygiene Scale | 6 months post baseline | 4.73 units on a scale | Standard Deviation 0.47 |
| Trust-building Self-management Together | Adolescent Sleep Hygiene Scale | 3 months post baseline | 4.56 units on a scale | Standard Deviation 0.31 |
| Trust-building Self-management Together | Adolescent Sleep Hygiene Scale | 6 months post baseline | 4.17 units on a scale | Standard Deviation 0.34 |
Secondary
Appointment Keeping
The Hill-Bone Compliance Appointment Keeping Scale has 3 items measured on a four-point Likert scale. One item is reverse scored and then the three items are summed, resulting in a score ranging from 3-12. This is a continuously distributed scale without clinical cutoff scores. Lower scores indicate greater appointment keeping (M = 5.27 ± 0.93).
Time frame: 3 and 6 months post baseline
Population: Using intent-to-treat principles, all participants were included in the analysis. However, four participants were lost to follow up at 6 months post baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Depression Management | Appointment Keeping | 3 months post baseline | 7.40 units on a scale | Standard Deviation 1.95 |
| Depression Management | Appointment Keeping | 6 months post baseline | 7.20 units on a scale | Standard Deviation 3.27 |
| Trust-building Self-management Together | Appointment Keeping | 3 months post baseline | 8.67 units on a scale | Standard Deviation 1.53 |
| Trust-building Self-management Together | Appointment Keeping | 6 months post baseline | 5.83 units on a scale | Standard Deviation 2.86 |
Secondary
Medication Adherence
The Extent of Non-Adherence Scale has 3 items measured on a 5-point Likert scale. A total score reflecting non-adherence is calculated by the mean of item responses, with a range of 1-5. Higher scores indicate greater levels of non-adherence and lower scores indicate greater adherence. The population mean = 1.8 (SD = 1.0).
Time frame: 3 and 6 months post baseline
Population: Using intent-to-treat principles, all participants were included in the analysis. However, four participants were lost to follow up at 6 months post baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Depression Management | Medication Adherence | 3 months post baseline | 2.33 units on a scale | Standard Deviation 1.76 |
| Depression Management | Medication Adherence | 6 months post baseline | 2.08 units on a scale | Standard Deviation 1.26 |
| Trust-building Self-management Together | Medication Adherence | 3 months post baseline | 4.67 units on a scale | Standard Deviation 0.58 |
| Trust-building Self-management Together | Medication Adherence | 6 months post baseline | 4.00 units on a scale | Standard Deviation 1.41 |
Secondary
Stress Management
The Adolescent Lifestyle Questionnaire Stress Management Subscale has four items on a 5 point Likert scale that are summed for a total score. The range is 5-20. Higher scores indicate greater stress management behavior. This is a continuously distributed scale without clinical cutoff scores. The population mean = 13.0 (SD = 3.6).
Time frame: 3 and 6 months post baseline
Population: Using intent-to-treat principles, all participants were included in the analysis. However, four participants were lost to follow up at 6 months post baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Depression Management | Stress Management | 3 months post baseline | 14.33 units on a scale | Standard Deviation 2.07 |
| Depression Management | Stress Management | 6 months post baseline | 13.40 units on a scale | Standard Deviation 2.41 |
| Trust-building Self-management Together | Stress Management | 3 months post baseline | 9.86 units on a scale | Standard Deviation 1.57 |
| Trust-building Self-management Together | Stress Management | 6 months post baseline | 12.43 units on a scale | Standard Deviation 2.15 |
Secondary
Youth Quality of Life Scale
The Youth Quality of Life Instrument-Short Form has 15 items measured on a 10 point Likert scale that are summed and t-scored, with higher scores indicating greater QoL. This is a continuously distributed scale without clinical cutoff scores. The quality of life mean t-score in the youth without depression (M= 81.0, SD= 11.7) is greater than the mean t-score in youth diagnosed with depression (M= 58.6, SD= 14.2).
Time frame: 3 and 6 months post baseline
Population: Using intent-to-treat principles, all participants were included in the analysis. However, four participants were lost to follow up at 6 months post baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Depression Management | Youth Quality of Life Scale | 3 months post baseline | 71.89 units on a scale | Standard Deviation 18.32 |
| Depression Management | Youth Quality of Life Scale | 6 months post baseline | 64.93 units on a scale | Standard Deviation 17.1 |
| Trust-building Self-management Together | Youth Quality of Life Scale | 3 months post baseline | 57.33 units on a scale | Standard Deviation 16.17 |
| Trust-building Self-management Together | Youth Quality of Life Scale | 6 months post baseline | 61.71 units on a scale | Standard Deviation 13.47 |