A Randomized Controlled Trial of PCIT-ED for Preschool Depression

NCT02076425 | Completed Results

• 1 other identifier: R01MH098454-02
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder, Major

Keywords

Depressive Disorder, Major; Child Psychiatry; Parent-Child Relationship; Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Preschool Feelings Checklist-Scale Version (PFC-Scale) Score

  completion of therapy (average of 20 weeks)

Other Outcomes (1)

• Children's Global Assessment Scale (CGAS) Score

  completion of therapy (average of 20 weeks)

Study Arms (2)

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.

Behavioral: PCIT-ED

Wait List

NO INTERVENTION

No intervention while subjects wait for PCIT-ED in the second phase of the study.

Interventions

PCIT-ED BEHAVIORAL

PCIT-ED

Eligibility Criteria

• Age: 36 Months - 83 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children who meet all DSM-IV MDD symptom criteria (adjusted for development)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Early Emotional Development Program

St Louis, Missouri, 63108, United States

Location

Related Publications (13)

• 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.

  PMID: 22040016 BACKGROUND

• 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.

  PMID: 29921144 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.

  PMID: 31376501 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.

  PMID: 30583852 RESULT

• 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.

  PMID: 36216984 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.

  PMID: 33865929 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.

  PMID: 33153527 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.

  PMID: 32935261 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.

  PMID: 32469454 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.

  PMID: 31515716 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.

  PMID: 31256293 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.

  PMID: 30577927 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.

  PMID: 27871643 DERIVED

Related Links

• Early Emotional Development Program Website

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Joan Luby
• Organization: Early Emotional Development Program at Washington University School of Medicine

lubyj@wustl.edu

3142862730

Study Officials

• Joan L Luby, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: March 3, 2014
• Study Start: January 13, 2014
• Primary Completion: March 31, 2018
• Study Completion: May 10, 2018
• Last Updated: December 2, 2019
• Results First Posted: December 2, 2019

Record last verified: 2019-11

Locations

US (1)