DepressionNCT01880814
Using SMART Experimental Design to Personalize Treatment for Child Depression
A study testing Cognitive Behavioral Therapy (CBT) and Caregiver-Child Treatment in people with Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of the study is: 1. To conduct a pilot SMART (Sequential, Multiple Assignment, Randomized) study with the long-term goal of developing a personalized treatment for child depression. 2. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive Behavioral Therapy (CBT) and Caregiver-Child Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 30 Nov 2018
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Current diagnosis of Major Depressive Disorder (MDD), Dysthymic Disorder (DD), or Depressive Disorder Not Otherwise Specified (NOS).
- If receiving psychiatric medication, dose should be stable for at least three months at enrollment.
Who cannot join
- A disorder other than depression as primary diagnosis.
- Autism Spectrum Disorders and Pervasive Developmental Delay or Disorder.
- Mental Retardation.
- Psychotic Disorders and Schizophrenia.
- Mania or Hypomania disorders.
- Acute suicidal behavior and/or acute plan that require higher level of care, and being hospitalized over the past year for a suicide attempt or for threatening to commit suicide.
- Participation in additional psychotherapy.
- Caregiver and/or children do not speak English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The purpose of the study is:
- To conduct a pilot SMART (Sequential, Multiple Assignment, Randomized) study with the long-term goal of developing a personalized treatment for child depression.
- To collect pilot data on ways to personalize treatment for child depression using cognitive behavioral therapy (CBT), caregiver-child treatment, or both.
Read the detailed description
Child depression is among the most prevalent and impairing pediatric conditions and constitutes a major public health concern. Unfortunately, treatment benefits are relatively modest and short-lived with sizeable percentages of children who maintain depressive symptoms following treatment. This problem may be addressed in part by personalizing treatment, including determining which children will benefit from CBT, which children will benefit from caregiver-child treatment, and which children will benefit from both. The goal of the current study is to pilot test an innovative experimental design called Sequential, Multiple Assignment, Randomized Trial (SMART), which is used for development of personalized treatments, collect pilot data, and assess the acceptability and feasibility of using this design, in preparation for a full-scale SMART in a larger clinical trial and for the development of personalized treatment.
- Conditions
- Depression
- Being tested
- Cognitive Behavioral Therapy (CBT), Caregiver-Child Treatment
- Keywords
- Depression, child, CBT, parent training, personalized treatment
- Medical subject headings
- Depression, Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
Children will first be randomized into Stage 1 of CBT or Caregiver-Child Treatment. Stage 1 will include six sessions. After Stage 1, child's response to treatment will be evaluated. Responders will be re-randomized into Stage 2 of no treatment or continuation of CBT. If randomized to no treatment, termination session will be completed. If randomized to continuation of CBT, the treatment will include six sessions and a termination session. Insufficient responders will be re-randomized into Stage 2 of continuation of CBT or Caregiver-Child Treatment. Stage 2 will include six sessions and a termination session.
Caregiver-Child TreatmentBehavioural
Children will first be randomized into Stage 1 of CBT or Caregiver-Child Treatment. Stage 1 will include six sessions. After Stage 1, child's response to treatment will be evaluated. Responders will be re-randomized into Stage 2 of no treatment or continuation of Caregiver-Child Treatment. If randomized to no treatment, termination session will be completed. If randomized to continuation of Caregiver-Child Treatment, the treatment will include six sessions and a termination session. Insufficient responders will be re-randomized into Stage 2 of continuation of Caregiver-Child Treatment or CBT. Stage 2 will include six sessions and a termination session.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | Type of talk therapy that focuses on individual behavioral and cognitive skills. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
| Caregiver-Child Treatment | Experimental | Type of talk therapy that involves the child and the caregiver and focuses on behavioral and cognitive skills. Receives: Behavioral: Caregiver-Child Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schedule for Affective Disorders and Schizophrenia for School-Aged Children-Present and Lifetime Versions (K-SADS-PL)
Clinician-administered semi-structured interview with children and caregivers assessing present episode and lifetime history of psychiatric diagnoses based on DSM-IV criteria.
Measured: Pre-treatment, Stage 1, Stage 2, 3-month follow-up
Children's Depression Rating Scale-Revised (CDRS-R)
Clinician-administered semi-structured child interview of depression.
Measured: Pre-treatment, Stage 1, Stage 2, 3-month follow-up
Children's Depression Inventory 2: Self Report (CDI2:SR)
Child self-report questionnaire assessing depressive symptoms.
Measured: Pre-treatment, Stage 1, Stage 2, 3-month follow-up
Children's Depression Inventory 2:Parent (CDI2:P)
Parent-report questionnaire assessing child's depressive symptoms.
Measured: Pre-treatment, Stage 1, Stage 2, 3-month follow-up, before each session
Clinical Global Impression (CGI)
Clinician assessment of child's symptom severity and level of improvement.
Measured: Pre-treatment, Stage 1, Stage 2, 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJun 2013
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dikla Eckshtain, PhD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880814
- Sponsor's protocol ID
- 5K23MH093491
- Status last verified
- Aug 2020
- First submitted
- 10 Jun 2013
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using SMART Experimental Design to Personalize Treatment for Child Depression
- ClinicalTrials.gov ID
- NCT01880814
- Acronym / sponsor ID
- 5K23MH093491
- Conditions
- Depression
- Keywords
- Depression, child, CBT, parent training, personalized treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 19 Jun 2013 (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.
The purpose of the study is:
- To conduct a pilot SMART (Sequential, Multiple Assignment, Randomized) study with the long-term goal of developing a personalized treatment for child depression.
- To collect pilot data on ways to personalize treatment for child depression using cognitive behavioral therapy (CBT), caregiver-child treatment, or both.
Detailed description
Child depression is among the most prevalent and impairing pediatric conditions and constitutes a major public health concern. Unfortunately, treatment benefits are relatively modest and short-lived with sizeable percentages of children who maintain depressive symptoms following treatment. This problem may be addressed in part by personalizing treatment, including determining which children will benefit from CBT, which children will benefit from caregiver-child treatment, and which children will benefit from both. The goal of the current study is to pilot test an innovative experimental design called Sequential, Multiple Assignment, Randomized Trial (SMART), which is used for development of personalized treatments, collect pilot data, and assess the acceptability and feasibility of using this design, in preparation for a full-scale SMART in a larger clinical trial and for the development of personalized treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT)Type of talk therapy that focuses on individual behavioral and cognitive skills. |
| Caregiver-Child Treatment | Experimental | Behavioral: Caregiver-Child TreatmentType of talk therapy that involves the child and the caregiver and focuses on behavioral and cognitive skills. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Current diagnosis of Major Depressive Disorder (MDD), Dysthymic Disorder (DD), or Depressive Disorder Not Otherwise Specified (NOS).
- If receiving psychiatric medication, dose should be stable for at least three months at enrollment.
Key exclusion criteria (8 listed)
- A disorder other than depression as primary diagnosis.
- Autism Spectrum Disorders and Pervasive Developmental Delay or Disorder.
- Mental Retardation.
- Psychotic Disorders and Schizophrenia.
- Mania or Hypomania disorders.
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 |
|---|---|---|
| Cognitive Behavioral Therapy (CBT)Children will first be randomized into Stage 1 of CBT or Caregiver-Child Treatment. Stage 1 will include six sessions. After Stage 1, child's response to treatment will be evaluated. Responders will be re-randomized into Stage 2 of no treatment or continuation of CBT. If randomized to no treatment, termination session will be completed. If randomized to continuation of CBT, the treatment will include six sessions and a termination session. Insufficient responders will be re-randomized into Stage 2 of continuation of CBT or Caregiver-Child Treatment. Stage 2 will include six sessions and a termination session. | Behavioural | Cognitive Behavioral Therapy (CBT) |
| Caregiver-Child TreatmentChildren will first be randomized into Stage 1 of CBT or Caregiver-Child Treatment. Stage 1 will include six sessions. After Stage 1, child's response to treatment will be evaluated. Responders will be re-randomized into Stage 2 of no treatment or continuation of Caregiver-Child Treatment. If randomized to no treatment, termination session will be completed. If randomized to continuation of Caregiver-Child Treatment, the treatment will include six sessions and a termination session. Insufficient responders will be re-randomized into Stage 2 of continuation of Caregiver-Child Treatment or CBT. Stage 2 will include six sessions and a termination session. | Behavioural | Caregiver-Child Treatment |
Primary outcome
Schedule for Affective Disorders and Schizophrenia for School-Aged Children-Present and Lifetime Versions (K-SADS-PL)
Time frame: Pre-treatment, Stage 1, Stage 2, 3-month follow-up
Clinician-administered semi-structured interview with children and caregivers assessing present episode and lifetime history of psychiatric diagnoses based on DSM-IV criteria.
Children's Depression Rating Scale-Revised (CDRS-R)
Time frame: Pre-treatment, Stage 1, Stage 2, 3-month follow-up
Clinician-administered semi-structured child interview of depression.
Children's Depression Inventory 2: Self Report (CDI2:SR)
Time frame: Pre-treatment, Stage 1, Stage 2, 3-month follow-up
Child self-report questionnaire assessing depressive symptoms.
Children's Depression Inventory 2:Parent (CDI2:P)
Time frame: Pre-treatment, Stage 1, Stage 2, 3-month follow-up, before each session
Parent-report questionnaire assessing child's depressive symptoms.
Clinical Global Impression (CGI)
Time frame: Pre-treatment, Stage 1, Stage 2, 3-month follow-up
Clinician assessment of child's symptom severity and level of improvement.
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 29 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT) and Caregiver-Child Treatment in people with Depression, run by Massachusetts General Hospital 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 8 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 29 Sep 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?
Schedule for Affective Disorders and Schizophrenia for School-Aged Children-Present and Lifetime Versions (K-SADS-PL) (time frame: Pre-treatment, Stage 1, Stage 2, 3-month follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2021.