AzTrials
AzTrials

Childhood Mental DisorderPCIT-ED-ACESNCT04399629

Trial of PCIT-ED in School for Preschoolers in Poverty

A study testing PCIT-ED and Parenting Wisely in people with Childhood Mental Disorder, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 48 to 83 months
Conditions the study is for
Childhood Mental Disorder
What is being tested?
PCIT-ED and Parenting Wisely
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteUnited States
Study dates
26 Sep 2019to 19 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 48 to 83 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Over the clinical threshold on the Teacher Report Form

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Early Emotional Development Program

    St Louis, Missouri, 63108

Other trials in United States

About this study

Official title: Preschool Based Prevention Targeting Emotion Development in Young Children Facing Adversity

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.

Being tested
PCIT-ED, Parenting Wisely
Keywords
Preschool, Parent-Child Relationship, Emotion Development, Therapy
Medical subject headings
Neurodevelopmental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCIT-EDBehavioural

    12 sessions of PCIT-ED therapy

  • Parenting WiselyBehavioural

    Teaches parents how to set more effective limits

Study groups in NCT04399629
Study groupRoleWhat they receive
PCIT-EDActive comparatorParent-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.
Receives: Behavioral: PCIT-ED
Parenting WiselyExperimentalOnline parenting training
Receives: Behavioral: Parenting Wisely

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. McArthur Health and Behavior Questionnaire

    The Health and Behavior Questionnaire was designed to assess children's mental health, physical health, and social and school functioning. The HBQ comprises multiple scales that measure children's symptoms (e.g., internalizing and externalizing symptoms and their subscales), physical health, social functioning (e.g., peer acceptance and rejection, prosocial behaviors), and school functioning (e.g., academic competence, school engagement). The HBQ also includes measures of children's health care utilization in the mental, physical, and school domains.

    Measured: completion of therapy (average of 12 weeks)

  2. Teacher Report Form

    This measure is used to obtain an overview of the child's behavior and functioning from the perspective of the teacher. The results of the form offer cross-informant comparisons in competencies, adaptive functioning and reported problems. This information is helpful for finding the child's strengths and where the child needs help.

    Measured: completion of therapy (average of 12 weeks)

Secondary outcomes (5)

  1. Eyberg Child Behavior Inventory

    The Eyberg Child Behavior Inventory (ECBI) is a measure that asks parents to report on a list of thirty-six conduct problem behaviors in their child. It is designed for children ages 2-16 years. The ECBI includes an Intensity Scale, which measures the frequency of each problem behavior, and a Problem Scale, which reflects parents' tolerance of the behaviors and the distress caused. The ECBI is intended to assess both the type of behavior problems and the degree to which parents find them problematic.

    Measured: completion of therapy (average of 12 weeks)

  2. Parent-Child Interaction: Marble Run and Drawing Task

    The marble run task and the drawing task are observational measures of parent-child interactions used in preschool aged children. In the marble run task, parents and children are asked to build a marble run, replicating a picture of a marble run. The drawing task asks parents and children to together decide on something to draw on a blank sheet of paper and each contribute individual lines to the drawing, while sharing one marker. Both tasks were designed to elicit mild stress while also asking parents and children to work together. Both of these tasks (each lasting approximately three minutes) asks parents to help their child with the task but not complete it for them. Participants are videotaped while engaging in these tasks, and parents' behavior and emotions are coded.

    Measured: completion of therapy (average of 12 weeks)

  3. Parenting Styles Questionnaire

    The Parenting Style Questionnaire is an 81-item True/False measure that asks parents about their feelings regarding sadness, fear, and anger.

    Measured: completion of therapy (average of 12 weeks)

  4. Parenting Styles and Dimensions Questionnaire

    The PSDQ is a 62-item questionnaire that is designed to assess parenting style. The parent is given a list of 62 behaviors and asked how much they and their spouse exhibit each behavior.

    Measured: completion of therapy (average of 12 weeks)

  5. Coping with Children's Negative Emotions Scale

    The CCNES assesses how parents typically respond to their child's negative emotions. Parents are given 12 hypothetical situations in which their child is upset or angry. Each situation is accompanied with 6 possible ways to respond to the child, and the parent is asked to rate the likelihood that they will use each response.

    Measured: completion of therapy (average of 12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2020
  2. Study start26 Sep 2019
  3. Primary completion19 Jan 2021
  4. Study completion19 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04399629
Sponsor's protocol ID
22-3250-18012
Acronym
PCIT-ED-ACES
Status last verified
Apr 2021
First submitted
18 May 2020
Last updated
6 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31376501

  • 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.

    PubMed 30583852

  • 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.

    PubMed 29921144

  • Hennefield L, Gilbert K, Donohue MR, Tillman R, McCoy A, Diggs G, Paul ZA, Kohl PL, Luby JL. Early Emotion Development Intervention Improves Mental Health Outcomes in Low-Income, High-Risk Community Children. Child Psychiatry Hum Dev. 2025 Oct;56(5):1457-1471. doi: 10.1007/s10578-023-01639-1. Epub 2024 Jan 14.

    PubMed 38221601

Questions about this trial

What is this clinical trial studying?

A study testing PCIT-ED and Parenting Wisely in people with Childhood Mental Disorder, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

McArthur Health and Behavior Questionnaire (time frame: completion of therapy (average of 12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04399629, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in