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DepressionNCT00595283

Effectiveness of Parent-Child Interaction and Emotion Development Therapy in Treating Preschool Children With Depression

A study testing Parent Child Interaction Therapy-Emotion Development (PCIT-ED) and Developmental Education Parenting Intervention (DEPI) in people with Depression, 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
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Trial summary

This study will evaluate the effectiveness of parent-child interaction therapy that includes an emotion development component in treating depression in preschool children. Read more about this study

Who is it for?
Ages 3 to 6 years
Conditions the study is for
Depression
What is being tested?
Parent Child Interaction Therapy-Emotion Development (PCIT-ED) and Developmental Education Parenting Intervention (DEPI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
Oct 2007to Oct 2010
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 3 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Meets DSM-IV symptom criteria for MDD based on parent report on PAPA
  • Currently resides and has resided with primary caregiver for more than 6 months prior to study entry

Who cannot join

  • Neurologic disorder (e.g., seizure disorder, closed head injury)
  • Autistic spectrum disorder
  • Has an IQ of less than 70, based on past testing or clear marked developmental delay
  • Currently participating in psychotherapy
  • If taking a psychotropic medication, must remain on stable dose of that medication throughout the course of study participation

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Washington University School of Medicine Early Emotional Development Program

    St Louis, Missouri, 63108

Other trials in United States

About this study

Official title: Early Intervention in Depression: Dyadic Emotion Development Therapy for Preschool Children

This study will evaluate the effectiveness of parent-child interaction therapy that includes an emotion development component in treating depression in preschool children.

Read the detailed description

While growing up, children experience a range of emotions that change with development and environment. Although all young children experience sadness at times, a main characteristic of young children is their ability to experience joy and excitement in pleasurable childhood activities. When a child seems perpetually sad and no longer seems interested in previously enjoyed activities, the child may be showing signs of early onset depression. Children who are depressed are at increased risk for a wide range of social, psychological, physical, and achievement-related problems. Two previous studies have established the validity of early onset depressive syndrome in preschoolers, confirming the need for treatment during the preschool period. This study will specifically adapt parent child interaction therapy (PCIT), a proven effective treatment for preschool disruptive disorders, for use in preschoolers with depression and will include an additional component to focus on emotion development (ED). The study will evaluate the effectiveness of PCIT-ED in treating depression in preschool children.

Participation in this two-stage study will last 16 weeks and will consist of initial assessments, 14 weeks of therapy, and a final assessment. Stage I will be used to assess the acceptability and reliability of the PCIT-ED manual, which will guide the treatment sessions. The protocol and assessment schedule will be the same for Stage I participants and Stage II participants assigned to PCIT-ED.

The initial assessments will include both child and parent participants. Child participants will be asked to complete a series of tasks, which will include playing with games and toys, making selections based on feelings, completing stories started by a research assistant, and participating in other activities designed to be fun and exciting. Parents will be interviewed about their child's feelings, emotions, behaviors, and development and also about how their child gets along at home, in school, and with friends. Parents will also answer questions concerning their own mental health and drug history, parenting style, and moods.

Participants will then be randomly assigned to receive PCIT-ED or Developmental Education Parenting Intervention (DEPI). Participants in both groups will attend fourteen 1-hour therapy sessions over a period of 14 weeks. For those assigned to PCIT-ED, most sessions will include both parent and child participants, but some will include parents only. During the parent-only sessions, the goals and procedures of upcoming therapy visits will be explained to parents. During sessions with both parent and child, participants will be taught positive parent-child interaction skills, ways to manage emotions, and relaxation techniques. After each therapy session, participants will be given homework that will involve practicing the skills learned in therapy sessions at home. At three points during the study, parents will also be asked to complete a brief questionnaire about their thoughts and feelings toward the therapy process. The therapy sessions for the participants assigned to DEPI will provide basic education in all areas of preschool development, with emphasis on social and emotional development. The initial assessments will be repeated for all participants at the end of treatment.

Conditions
Depression
Being tested
Parent Child Interaction Therapy-Emotion Development (PCIT-ED), Developmental Education Parenting Intervention (DEPI)
Keywords
Preschool Onset Major Depressive Disorder, Preschool Depression, Emotion Development, Parent Child Interaction
Medical subject headings
Depression

What participants receive

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

  • Parent Child Interaction Therapy-Emotion Development (PCIT-ED)Behavioural

    Also called PCIT-ED

    PCIT-ED includes fourteen 1-hour therapy sessions over 14 weeks. Sessions will focus on positive parent-child interactions skills, ways to manage emotions, and relaxation techniques.

  • Developmental Education Parenting Intervention (DEPI)Behavioural

    Also called DEPI

    DEPI includes 14 weekly, 1-hour education sessions covering a range of child development and parenting topics. Classes are in a small group format and will emphasize emotional and social development.

Study groups in NCT00595283
Study groupRoleWhat they receive
1ExperimentalParticipants assigned to Parent-Child Interaction Therapy-Emotional Development
Receives: Behavioral: Parent Child Interaction Therapy-Emotion Development (PCIT-ED)
2Active comparatorParticipants assigned to Developmental Education Parenting Intervention
Receives: Behavioral: Developmental Education Parenting Intervention (DEPI)

What is being measured

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

  1. Depression diagnosis and severity using the Preschool-Age Psychiatric Assessment (PAPA) for major depressive disorder (MDD) module

    Measured: Measured at Week 14

Timeline

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

  1. First posted16 Jan 2008 (estimated)
  2. Study startOct 2007
  3. Primary completionAug 2010
  4. Study completionOct 2010

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
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00595283
Sponsor's protocol ID
R34MH080163
Other IDs
R34MH080163, DSIR 84-CTS
Status last verified
Mar 2013
First submitted
4 Jan 2008
Last updated
22 Mar 2013
Results posted
No
Data monitoring committee
No

Publications

  • Hennefield L, Whalen DJ, Wood G, Chavarria MC, Luby JL. Changing Conceptions of Death as a Function of Depression Status, Suicidal Ideation, and Media Exposure in Early Childhood. J Am Acad Child Adolesc Psychiatry. 2019 Mar;58(3):339-349. doi: 10.1016/j.jaac.2018.07.909. Epub 2019 Jan 8.

    PubMed 30768413

Questions about this trial

What is this clinical trial studying?

A study testing Parent Child Interaction Therapy-Emotion Development (PCIT-ED) and Developmental Education Parenting Intervention (DEPI) in people with Depression, 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 2 inclusion and 5 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 22 Mar 2013. 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?

Depression diagnosis and severity using the Preschool-Age Psychiatric Assessment (PAPA) for major depressive disorder (MDD) module (time frame: Measured at Week 14). 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 NCT00595283, which also lists 1 linked publication.

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 22 Mar 2013.

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