Trial of PCIT-ED in School for Preschoolers in Poverty (PCIT-ED-ACES)

The Washington University

Status: Completed

Conditions: Childhood Mental Disorder

Treatments: Behavioral: PCIT-ED; Behavioral: Parenting Wisely

Study type: Interventional

Funder types: Other

Identifiers

NCT04399629

22-3250-18012

Details and patient eligibility

About

A shorted form of the previously tested, Parent Child Interaction Therapy Emotion Development (PCIT-ED) will be conducted with a sample of preschoolers who exhibit symptoms of behavioral problems as rated by teacher. Children aged 3-7 will be randomized to a 12-week PCIT-ED delivered by trained therapists in the school setting or an on-line parent training called "Parenting Wisely (PW)". Children will have a 60% chance of being randomized to PCIT-ED and 40% to PW. The treatment will be provided to eligible children in the Jennings School District at the school site. 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- and post-assessments at Washington University School of Medicine Early Emotional Development Program.

Preschoolers over age 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 or PW.

Compared to those randomized to PW, we expect preschoolers who undergo PCIT-ED will show significantly increased rates of remission of behavioral problems, greater reductions in symptoms, and decreases in impairment. We hypothesize that they 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 PW, parents who undergo PCIT-ED will show significantly greater increases in emotion skill learning and reductions in MDD symptoms and parenting stress.

Enrollment: 62 patients

Sex: All

Ages: 48 to 83 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over the clinical threshold on the Teacher Report Form

Exclusion criteria

• Autism
• Major neurological disorder
• Participating in active weekly individual or family therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

PCIT-ED

Active Comparator group

Description:

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.

Treatment:

Behavioral: PCIT-ED

Parenting Wisely

Experimental group

Description:

Online parenting training

Treatment:

Behavioral: Parenting Wisely