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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCIT-ED | Experimental | 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. |
|
| Wait List | No Intervention | No intervention while subjects wait for PCIT-ED in the second phase of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCIT-ED | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | completion of therapy (average of 20 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | completion of therapy (average of 20 weeks) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joan L Luby, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Early Emotional Development Program | St Louis | Missouri | 63108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22040016 | Background | Luby J, Lenze S, Tillman R. A novel early intervention for preschool depression: findings from a pilot randomized controlled trial. J Child Psychol Psychiatry. 2012 Mar;53(3):313-22. doi: 10.1111/j.1469-7610.2011.02483.x. Epub 2011 Oct 31. | |
| 29921144 | Result | Luby JL, Barch DM, Whalen D, Tillman R, Freedland KE. A Randomized Controlled Trial of Parent-Child Psychotherapy Targeting Emotion Development for Early Childhood Depression. Am J Psychiatry. 2018 Nov 1;175(11):1102-1110. doi: 10.1176/appi.ajp.2018.18030321. Epub 2018 Jun 20. |
| Label | URL |
|---|---|
| Early Emotional Development Program Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Wait List | No intervention while subjects wait for PCIT-ED in the second phase of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Wait List |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | number of symptoms (0-9) | completion of therapy (average of 20 weeks) |
|
Baseline assessment through study completion (approximately 40 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joan Luby | Early Emotional Development Program at Washington University School of Medicine | 3142862730 | lubyj@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2014 | Nov 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| completion of therapy (average of 20 weeks) |
| 31376501 | Result | Luby JL, Gilbert K, Whalen D, Tillman R, Barch DM. The Differential Contribution of the Components of Parent-Child Interaction Therapy Emotion Development for Treatment of Preschool Depression. J Am Acad Child Adolesc Psychiatry. 2020 Jul;59(7):868-879. doi: 10.1016/j.jaac.2019.07.937. Epub 2019 Jul 31. |
| 30583852 | Result | Barch DM, Whalen D, Gilbert K, Kelly D, Kappenman ES, Hajcak G, Luby JL. Neural Indicators of Anhedonia: Predictors and Mechanisms of Treatment Change in a Randomized Clinical Trial in Early Childhood Depression. Biol Psychiatry. 2019 May 15;85(10):863-871. doi: 10.1016/j.biopsych.2018.11.021. Epub 2018 Dec 4. |
|
| 40582466 | Derived | Elansary M, Barch DM, Tillman R, Dandrea CB, Vogel AC, Donohue MR, Hennefield L, Gilbert K, Luby JL. Preadolescent Benefits of Parent-Child Interaction Therapy Emotion Development for Preschool Depression: 4-Year Follow-Up. J Am Acad Child Adolesc Psychiatry. 2026 May;65(5):669-684. doi: 10.1016/j.jaac.2025.06.011. Epub 2025 Jun 27. |
| 36216984 | Derived | Schwartz KTG, Chronis-Tuscano A, Tillman R, Whalen D, Gilbert KE, Luby J. Parent-child psychotherapy targeting emotion development: unpacking the impact of parental depression on child, parenting and engagement outcomes. Eur Child Adolesc Psychiatry. 2023 Dec;32(12):2491-2501. doi: 10.1007/s00787-022-02093-5. Epub 2022 Oct 10. |
| 33865929 | Derived | Donohue MR, Hoyniak CP, Tillman R, Barch DM, Luby J. Callous-Unemotional Traits as an Intervention Target and Moderator of Parent-Child Interaction Therapy-Emotion Development Treatment for Preschool Depression and Conduct Problems. J Am Acad Child Adolesc Psychiatry. 2021 Nov;60(11):1394-1403. doi: 10.1016/j.jaac.2021.03.018. Epub 2021 May 20. |
| 33153527 | Derived | Barch DM, Whalen D, Gilbert K, Kelly D, Kappenman ES, Hajcak G, Luby JL. Neural Indicators of Anhedonia: Predictors and Mechanisms of Treatment Change in a Randomized Clinical Trial in Early Childhood Depression. Biol Psychiatry. 2020 Dec 1;88(11):879-887. doi: 10.1016/j.biopsych.2020.06.032. |
| 32935261 | Derived | Hoyniak CP, Whalen DJ, Barch D, Luby JL. Sleep problems in preschool-onset major depressive disorder: the effect of treatment with parent-child interaction therapy-emotion development. Eur Child Adolesc Psychiatry. 2021 Sep;30(9):1463-1474. doi: 10.1007/s00787-020-01641-1. Epub 2020 Sep 15. |
| 32469454 | Derived | Whalen DJ, Gilbert KE, Luby JL. Changes in self-reported and observed parenting following a randomized control trial of parent-child interaction therapy for the treatment of preschool depression. J Child Psychol Psychiatry. 2021 Jan;62(1):86-96. doi: 10.1111/jcpp.13263. Epub 2020 May 29. |
| 31515716 | Derived | Whalen DJ, Gilbert KE, Kelly D, Hajcak G, Kappenman ES, Luby JL, Barch DM. Preschool-Onset Major Depressive Disorder is Characterized by Electrocortical Deficits in Processing Pleasant Emotional Pictures. J Abnorm Child Psychol. 2020 Jan;48(1):91-108. doi: 10.1007/s10802-019-00585-8. |
| 31256293 | Derived | Gilbert K, Barch DM, Luby JL. The Overcontrol in Youth Checklist (OCYC): Behavioral and Neural Validation of a Parent-Report of Child Overcontrol in Early Childhood. Child Psychiatry Hum Dev. 2020 Feb;51(1):27-38. doi: 10.1007/s10578-019-00907-3. |
| 30577927 | Derived | Luby JL, Whalen D, Tillman R, Barch DM. Clinical and Psychosocial Characteristics of Young Children With Suicidal Ideation, Behaviors, and Nonsuicidal Self-Injurious Behaviors. J Am Acad Child Adolesc Psychiatry. 2019 Jan;58(1):117-127. doi: 10.1016/j.jaac.2018.06.031. Epub 2018 Oct 22. |
| 27871643 | Derived | Belden AC, Irvin K, Hajcak G, Kappenman ES, Kelly D, Karlow S, Luby JL, Barch DM. Neural Correlates of Reward Processing in Depressed and Healthy Preschool-Age Children. J Am Acad Child Adolesc Psychiatry. 2016 Dec;55(12):1081-1089. doi: 10.1016/j.jaac.2016.09.503. Epub 2016 Oct 4. |
No intervention while subjects wait for PCIT-ED in the second phase of the study. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| K-SADS-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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale (0-100) |
|
| OG001 | Wait List | No intervention while subjects wait for PCIT-ED in the second phase of the study. |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | completion of therapy (average of 20 weeks) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale (0-100) | completion of therapy (average of 20 weeks) |
|
|
|
| 0 |
| 114 |
| 0 |
| 114 |
| 0 |
| 114 |
| EG001 | Wait List | No intervention while subjects wait for PCIT-ED in the second phase of the study. | 0 | 115 | 0 | 115 | 0 | 115 |
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