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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants assigned to Parent-Child Interaction Therapy-Emotional Development Receives: Behavioral: Parent Child Interaction Therapy-Emotion Development (PCIT-ED) |
| 2 | Active comparator | Participants 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.
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.
- First posted16 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionAug 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Joan Luby, MD, Washington University School of Medicine
- Investigators
- Joan L. Luby, MD, Principal investigator, Washington University School of Medicine
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention in Depression: Dyadic Emotion Development Therapy for Preschool Children
- ClinicalTrials.gov ID
- NCT00595283
- Acronym / sponsor ID
- R34MH080163
- Conditions
- Depression
- Keywords
- Preschool Onset Major Depressive Disorder, Preschool Depression, Emotion Development, Parent Child Interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness of parent-child interaction therapy that includes an emotion development component in treating depression in preschool children.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Parent Child Interaction Therapy-Emotion Development (PCIT-ED)Participants assigned to Parent-Child Interaction Therapy-Emotional Development |
| 2 | Active comparator | Behavioral: Developmental Education Parenting Intervention (DEPI)Participants assigned to Developmental Education Parenting Intervention |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent Child Interaction Therapy-Emotion Development (PCIT-ED)Also: PCIT-EDPCIT-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. | Behavioural | 1 |
| Developmental Education Parenting Intervention (DEPI)Also: DEPIDEPI 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. | Behavioural | 2 |
Primary outcome
Depression diagnosis and severity using the Preschool-Age Psychiatric Assessment (PAPA) for major depressive disorder (MDD) module
Time frame: Measured at Week 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
- Derived from this study: PubMed 30768413Hennefield 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan L. Luby, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
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.