Depressive Disorder, Major
Conditions
Keywords
Depressive Disorder, Major, Child Psychiatry, Parent-Child Relationship, Therapy
Brief summary
Parent Child Interaction Therapy Emotion Development (PCIT-ED) will be conducted with a sample of preschoolers who exhibit symptoms of depression compared to a wait list (WL) control after which participants will receive the active treatment. PCIT-ED is an expansion of PCIT, a well-known, widely used and proven effective treatment for preschool disruptive disorders. To address early disturbances of mood and affect, a novel ED module was added based on empirical data in emotion development. The ED module targets parent emotion learning skills with the goal of training the parent to serve as a more effective emotion teacher and coach to the child. The goal of the ED module is to enhance the child's capacity for emotion recognition and regulation or emotional competence. In order to test the efficacy of PCIT-ED, to estimate accurate effect sizes and to investigate mediators and moderators of treatment response participants will complete comprehensive pre-, interval, and post-assessments. Preschoolers over 3 will be offered the option of enrolling in an add-on electroencephalography and magnetic resonance imagery study, to investigate neural changes associated with PCIT-ED. Compared to those randomized to the WL, preschoolers who undergo PCIT-ED will show significantly increased rates of remission, greater reductions in MDD symptoms, and decreases in impairment; and will show significantly greater increases in emotional competence measured by the ability to accurately identify emotions in themselves and others and the ability to effectively regulate intense emotions. Compared to those on the WL, parents who undergo PCIT-ED will show significantly greater increases in emotion skill learning and reductions in MDD symptoms and parenting stress.
Interventions
BEHAVIORALPCIT-ED
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
36 Months to 83 Months
Healthy volunteers
No
Inclusion criteria
* Children who meet all DSM-IV MDD symptom criteria (adjusted for development)
Exclusion criteria
* Children with serious chronic medical illness * Children with Autistic Spectrum Disorders (based on clinical diagnosis or Social Responsiveness Scale scores which will be administered when there is suspicion of an ASD) * Children with significant speech delays * Children with general developmental delays or IQ \< 70 * Children with chronic neurological problems/illnesses * Children adopted after 12 months of age * Children on antidepressants * Children taking unstable doses of other psychotropic medications without antidepressant properties * Children participating in ongoing psychotherapy * Children in unstable placements (not with same caregiver for 6 months prior to study enrollment) * Children who are too ill to wait 18 weeks for treatment (e.g. having active suicidal ideation and/or in acute/serious distress)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (KSADS-EC) MDD Core Symptom Score | completion of therapy (average of 20 weeks) | The Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (K-SADS-EC) is a semi-structured clinical interview for DSM-5 disorders adapted for use in children aged 3-6. The MDD core symptom score was the number of core MDD symptoms endorsed on the K-SADS-EC. These 9 symptoms were (1) depressed mood, (2) anhedonia, (3) insomnia/hypersomnia, (4) fatigue, (5) decreased concentration, (6) weight/appetite change, (7) psychomotor agitation/retardation, (8) worthlessness/guilt, (9) suicidal thoughts/behaviors. The range of possible values is 0-9, with 9 being the worst outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preschool Feelings Checklist-Scale Version (PFC-Scale) Score | completion of therapy (average of 20 weeks) | The Preschool Feelings Checklist - Scale Version (PFC-Scale), was adapted from the PFC, which is a validated screening checklist used to capture young children at high risk for MDD. The PFC-Scale is a 23-item Likert scale with possible values of 0, 1, 2, 3, or 4 for each item. The total score is a sum of the 23 items, so the range of possible values is 0-92, with 92 being the most severe score possible. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Children's Global Assessment Scale (CGAS) Score | completion of therapy (average of 20 weeks) | The Children's Global Assessment Scale (CGAS) is a standardized instrument that measures children's global level of impairment completed by the clinician-rater. The possible range of values is 0-100, with 0 indicating the most severe global impairment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PCIT-ED Parent-Child Interaction Therapy - Emotional Development (PCIT-ED) is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention.
PCIT-ED | 114 |
| Wait List No intervention while subjects wait for PCIT-ED in the second phase of the study. | 115 |
| Total | 229 |
Baseline characteristics
| Characteristic | PCIT-ED | Total | Wait List |
|---|---|---|---|
| Age, Continuous | 5.14 years STANDARD_DEVIATION 0.97 | 5.21 years STANDARD_DEVIATION 1.05 | 5.28 years STANDARD_DEVIATION 1.13 |
| Children's Global Assessment Scale (CGAS) Score | 44.00 units on a scale (0-100) STANDARD_DEVIATION 6.51 | 43.30 units on a scale (0-100) STANDARD_DEVIATION 6.56 | 42.61 units on a scale (0-100) STANDARD_DEVIATION 6.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 25 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants | 204 Participants | 105 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| K-SADS-EC MDD Core Symptom Score | 5.49 units on a scale STANDARD_DEVIATION 1.47 | 5.60 units on a scale STANDARD_DEVIATION 1.49 | 5.71 units on a scale STANDARD_DEVIATION 1.51 |
| Preschool Feelings Checklist-Scale Version (PFC-Scale) Score | 38.77 units on a scale STANDARD_DEVIATION 9.57 | 40.25 units on a scale STANDARD_DEVIATION 10.59 | 41.71 units on a scale STANDARD_DEVIATION 11.37 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 27 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 25 Participants | 15 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 | 94 Participants | 176 Participants | 82 Participants |
| Region of Enrollment United States | 114 Participants | 229 Participants | 115 Participants |
| Sex: Female, Male Female | 38 Participants | 80 Participants | 42 Participants |
| Sex: Female, Male Male | 76 Participants | 149 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 114 | 0 / 115 |
| other Total, other adverse events | 0 / 114 | 0 / 115 |
| serious Total, serious adverse events | 0 / 114 | 0 / 115 |
Outcome results
Primary
Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (KSADS-EC) MDD Core Symptom Score
The Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (K-SADS-EC) is a semi-structured clinical interview for DSM-5 disorders adapted for use in children aged 3-6. The MDD core symptom score was the number of core MDD symptoms endorsed on the K-SADS-EC. These 9 symptoms were (1) depressed mood, (2) anhedonia, (3) insomnia/hypersomnia, (4) fatigue, (5) decreased concentration, (6) weight/appetite change, (7) psychomotor agitation/retardation, (8) worthlessness/guilt, (9) suicidal thoughts/behaviors. The range of possible values is 0-9, with 9 being the worst outcome.
Time frame: completion of therapy (average of 20 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PCIT-ED | Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (KSADS-EC) MDD Core Symptom Score | 1.74 number of symptoms (0-9) | Standard Deviation 1.69 |
| Wait List | Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (KSADS-EC) MDD Core Symptom Score | 4.15 number of symptoms (0-9) | Standard Deviation 2.04 |
Secondary
Preschool Feelings Checklist-Scale Version (PFC-Scale) Score
The Preschool Feelings Checklist - Scale Version (PFC-Scale), was adapted from the PFC, which is a validated screening checklist used to capture young children at high risk for MDD. The PFC-Scale is a 23-item Likert scale with possible values of 0, 1, 2, 3, or 4 for each item. The total score is a sum of the 23 items, so the range of possible values is 0-92, with 92 being the most severe score possible.
Time frame: completion of therapy (average of 20 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PCIT-ED | Preschool Feelings Checklist-Scale Version (PFC-Scale) Score | 20.13 units on a scale | Standard Deviation 9.68 |
| Wait List | Preschool Feelings Checklist-Scale Version (PFC-Scale) Score | 33.24 units on a scale | Standard Deviation 11.12 |
Other Pre-specified
Children's Global Assessment Scale (CGAS) Score
The Children's Global Assessment Scale (CGAS) is a standardized instrument that measures children's global level of impairment completed by the clinician-rater. The possible range of values is 0-100, with 0 indicating the most severe global impairment.
Time frame: completion of therapy (average of 20 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PCIT-ED | Children's Global Assessment Scale (CGAS) Score | 76.83 units on a scale (0-100) | Standard Deviation 16.61 |
| Wait List | Children's Global Assessment Scale (CGAS) Score | 55.75 units on a scale (0-100) | Standard Deviation 17.14 |