Depressive Disorder, Major Clinical Trial
Official title:
A Randomized Controlled Trial of PCIT-ED for Preschool Depression
Verified date | November 2019 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 229 |
Est. completion date | May 10, 2018 |
Est. primary completion date | March 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 36 Months to 83 Months |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Early Emotional Development Program | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
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):863-87 — View Citation
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. — View Citation
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.2018.18030 — View Citation
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. 2019 Jul 31. pii: S0890-8 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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) | |
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. | completion of therapy (average of 20 weeks) | |
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. | completion of therapy (average of 20 weeks) |
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