DepressionSOSNCT01159041
Systems of Support Study for Childhood Depression
A study testing Family Focused Treatment (FFT) and Individual Treatment (IP) in people with Depression, run by Boston University Charles River Campus at 2 sites in United States.
Trial summary
This study is designed to compare two treatments for depression in pre-adolescent (7-13 year old) children. A family-focused treatment will be compared to an individual child-focused treatment in this 14-week intervention. Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Depression
- What is being tested?
- Family Focused Treatment (FFT) and Individual Treatment (IP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2010to 31 Dec 2016
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- current Depressive Disorder
- ages 7-13 years
- living with at least one biological parent willing to participate
Who cannot join
- thought disturbance
- severe conduct disorders
- unstable on antidepressant medications
- continuation in current non-study treatment
- non-English speaking
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston University
Boston, Massachusetts, 02215
UCLA Semel Institute for Neuroscience and Human Behavior
Los Angeles, California, 90095
About this study
Official title: Evaluation of Family Focused Treatment for Childhood Depression
This study is designed to compare two treatments for depression in pre-adolescent (7-13 year old) children. A family-focused treatment will be compared to an individual child-focused treatment in this 14-week intervention.
Read the detailed description
Childhood-onset depression is an impairing and often recurrent and persistent disorder that impacts current and later development resulting in high personal, social, and economic costs. Despite the costs of early-onset depression, the emphasis in current practice parameters on an initial course of psychosocial treatment, and extensive research on adolescent depression, we currently lack randomized controlled trials evaluating psychosocial treatments for children with depressive disorders.
The present proposal aims to address this gap in knowledge regarding optimal psychosocial treatment strategies for children suffering from depressive disorders. We propose a 2-site randomized controlled trial to evaluate the efficacy of Family Focused Treatment (FFT), as compared to an individual client-centered psychotherapy (IP) modeled after "usual" community care. FFT adopts an interpersonal model for understanding how depressive symptoms are maintained, emphasizes developing family skills/strategies for altering interpersonal processes, and works on building a family environment that supports recovery and enhances stress resistance and resilience. This approach may be particularly appropriate to the developmental needs of depressed children, given their dependence on parents, the potential of FFT to address the needs of multiple family members, and our data supporting benefits on depression, functioning, and other co-occurring symptoms.
The proposed project will enroll 140 children (ages 8-12) with depressive disorders. Children will be randomly assigned to receive a 14-week trial of either FFT or IP. At study entry, immediately post-treatment, and at a 9-month post-treatment follow-up all participants will undergo intensive evaluation of clinical state and psychosocial and family functioning.
- Conditions
- Depression
- Being tested
- Family Focused Treatment (FFT), Individual Treatment (IP)
- Keywords
- Depression, children, adolescent, family
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Focused Treatment (FFT)Behavioural
FFT is designed to specifically address the developmental needs of school-aged children and their parents through an emphasis on fostering positive and supportive parent-child interactions that scaffold the development of a positive self, to help parents provide the child additional positive feedback on his/her developmentally appropriate achievements, and to enhance family and child coping. This treatment is conducted with the child and his/her parent(s) and includes education about depression, communication training, relationship enhancement, and problem-solving.
Individual Treatment (IP)Behavioural
The goals of the treatment are to foster the therapeutic relationship, to provide a supportive and empathic setting where the child can come to better understand his/her emotions/feelings and address issues underlying current symptoms. Therapeutic goals will be addressed through reflection and clarification of feelings/emotions and understanding the child's perception of the context of depressed feelings.
| Study group | Role | What they receive |
|---|---|---|
| Family Focused Treatment (FFT) | Experimental | 15 session family-based treatment emphasizing improving relationship skills to combat depression symptoms and support recovery. Receives: Behavioral: Family Focused Treatment (FFT) |
| Individual Treatment (IP) | Active comparator | 15 session individually-based treatment to assist children in understanding the causes of their symptoms. Receives: Behavioral: Individual Treatment (IP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate Depression Treatment Response
50% improvement on Children's Depression Rating Scale-Revised
Measured: 3 months
Secondary outcomes (2)
Interviewer-rated Depression Severity
Children's Depression Rating Scale-Revised (CDRS-R) measures depression severity over the past two weeks. The 17-item CDRS-R has total scores ranging from 17 to 113 with scores of 40 or greater considered indicative of a depression diagnosis. Used in pharmacological and psychosocial treatment studies, it provides comparability across studies.
Measured: 3 Months
Children's Self-Report of Depression Symptoms
Child Depression Inventory (CDI) is a 27-item self-report measure. Scores range from 0 to 54 with higher scores reflecting higher levels of symptoms.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2015
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martha C Thompson, PhD, Principal investigator, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159041
- Sponsor's protocol ID
- 1R01MH082861
- Other IDs
- R01MH082856-01A2, R01MH082861-01A2
- Acronym
- SOS
- Status last verified
- Jan 2018
- First submitted
- 7 Jul 2010
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: This is a small open trial and findings will be too preliminary.
Publications
Tompson MC, Pierre CB, Haber FM, Fogler JM, Groff AR, Asarnow JR. Family-focused treatment for childhood-onset depressive disorders: results of an open trial. Clin Child Psychol Psychiatry. 2007 Jul;12(3):403-20. doi: 10.1177/1359104507078474.
PubMed 17953128Tompson MC, Boger KD, Asarnow JR. Enhancing the developmental appropriateness of treatment for depression in youth: integrating the family in treatment. Child Adolesc Psychiatr Clin N Am. 2012 Apr;21(2):345-84. doi: 10.1016/j.chc.2012.01.003. Epub 2012 Mar 17.
PubMed 22537731Tompson MC, Sugar CA, Langer DA, Asarnow JR. A Randomized Clinical Trial Comparing Family-Focused Treatment and Individual Supportive Therapy for Depression in Childhood and Early Adolescence. J Am Acad Child Adolesc Psychiatry. 2017 Jun;56(6):515-523. doi: 10.1016/j.jaac.2017.03.018. Epub 2017 Apr 7.
PubMed 28545757Tompson MC, Langer DA, Hughes JL, Asarnow JR. Family-Focused Treatment for Childhood Depression: Model and Case Illustrations. Cogn Behav Pract. 2017 Aug;24(3):269-287. doi: 10.1016/j.cbpra.2016.06.003.
PubMed 28966545Asarnow JR, Tompson MC, Klomhaus AM, Babeva K, Langer DA, Sugar CA. Randomized controlled trial of family-focused treatment for child depression compared to individual psychotherapy: one-year outcomes. J Child Psychol Psychiatry. 2020 Jun;61(6):662-671. doi: 10.1111/jcpp.13162. Epub 2019 Dec 15.
PubMed 31840263
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Family Focused Treatment for Childhood Depression
- ClinicalTrials.gov ID
- NCT01159041
- Acronym / sponsor ID
- SOS / 1R01MH082861
- Conditions
- Depression
- Keywords
- Depression, children, adolescent, family
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, National Institute of Mental Health (NIMH)
- Study start
- Jan 2010
- Primary completion
- May 2015 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 9 Jul 2010 (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 is designed to compare two treatments for depression in pre-adolescent (7-13 year old) children. A family-focused treatment will be compared to an individual child-focused treatment in this 14-week intervention.
Detailed description
Childhood-onset depression is an impairing and often recurrent and persistent disorder that impacts current and later development resulting in high personal, social, and economic costs. Despite the costs of early-onset depression, the emphasis in current practice parameters on an initial course of psychosocial treatment, and extensive research on adolescent depression, we currently lack randomized controlled trials evaluating psychosocial treatments for children with depressive disorders.
The present proposal aims to address this gap in knowledge regarding optimal psychosocial treatment strategies for children suffering from depressive disorders. We propose a 2-site randomized controlled trial to evaluate the efficacy of Family Focused Treatment (FFT), as compared to an individual client-centered psychotherapy (IP) modeled after "usual" community care. FFT adopts an interpersonal model for understanding how depressive symptoms are maintained, emphasizes developing family skills/strategies for altering interpersonal processes, and works on building a family environment that supports recovery and enhances stress resistance and resilience. This approach may be particularly appropriate to the developmental needs of depressed children, given their dependence on parents, the potential of FFT to address the needs of multiple family members, and our data supporting benefits on depression, functioning, and other co-occurring symptoms.
The proposed project will enroll 140 children (ages 8-12) with depressive disorders. Children will be randomly assigned to receive a 14-week trial of either FFT or IP. At study entry, immediately post-treatment, and at a 9-month post-treatment follow-up all participants will undergo intensive evaluation of clinical state and psychosocial and family functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Focused Treatment (FFT) | Experimental | Behavioral: Family Focused Treatment (FFT)15 session family-based treatment emphasizing improving relationship skills to combat depression symptoms and support recovery. |
| Individual Treatment (IP) | Active comparator | Behavioral: Individual Treatment (IP)15 session individually-based treatment to assist children in understanding the causes of their symptoms. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- current Depressive Disorder
- ages 7-13 years
- living with at least one biological parent willing to participate
Key exclusion criteria (5 listed)
- thought disturbance
- severe conduct disorders
- unstable on antidepressant medications
- continuation in current non-study treatment
- non-English speaking
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 |
|---|---|---|
| Family Focused Treatment (FFT)FFT is designed to specifically address the developmental needs of school-aged children and their parents through an emphasis on fostering positive and supportive parent-child interactions that scaffold the development of a positive self, to help parents provide the child additional positive feedback on his/her developmentally appropriate achievements, and to enhance family and child coping. This treatment is conducted with the child and his/her parent(s) and includes education about depression, communication training, relationship enhancement, and problem-solving. | Behavioural | Family Focused Treatment (FFT) |
| Individual Treatment (IP)The goals of the treatment are to foster the therapeutic relationship, to provide a supportive and empathic setting where the child can come to better understand his/her emotions/feelings and address issues underlying current symptoms. Therapeutic goals will be addressed through reflection and clarification of feelings/emotions and understanding the child's perception of the context of depressed feelings. | Behavioural | Individual Treatment (IP) |
Primary outcome
Adequate Depression Treatment Response
Time frame: 3 months
50% improvement on Children's Depression Rating Scale-Revised
2 secondary outcomes
Interviewer-rated Depression Severity
Time frame: 3 Months
Children's Self-Report of Depression Symptoms
Time frame: 3 Months
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 17 Jul 2026.
- Background: PubMed 17953128Tompson MC, Pierre CB, Haber FM, Fogler JM, Groff AR, Asarnow JR. Family-focused treatment for childhood-onset depressive disorders: results of an open trial. Clin Child Psychol Psychiatry. 2007 Jul;12(3):403-20. doi: 10.1177/1359104507078474.
- Results publication: PubMed 22537731Tompson MC, Boger KD, Asarnow JR. Enhancing the developmental appropriateness of treatment for depression in youth: integrating the family in treatment. Child Adolesc Psychiatr Clin N Am. 2012 Apr;21(2):345-84. doi: 10.1016/j.chc.2012.01.003. Epub 2012 Mar 17.
- Results publication: PubMed 28545757Tompson MC, Sugar CA, Langer DA, Asarnow JR. A Randomized Clinical Trial Comparing Family-Focused Treatment and Individual Supportive Therapy for Depression in Childhood and Early Adolescence. J Am Acad Child Adolesc Psychiatry. 2017 Jun;56(6):515-523. doi: 10.1016/j.jaac.2017.03.018. Epub 2017 Apr 7.
- Results publication: PubMed 28966545Tompson MC, Langer DA, Hughes JL, Asarnow JR. Family-Focused Treatment for Childhood Depression: Model and Case Illustrations. Cogn Behav Pract. 2017 Aug;24(3):269-287. doi: 10.1016/j.cbpra.2016.06.003.
- Derived from this study: PubMed 31840263Asarnow JR, Tompson MC, Klomhaus AM, Babeva K, Langer DA, Sugar CA. Randomized controlled trial of family-focused treatment for child depression compared to individual psychotherapy: one-year outcomes. J Child Psychol Psychiatry. 2020 Jun;61(6):662-671. doi: 10.1111/jcpp.13162. Epub 2019 Dec 15.
- Individual participant dataSharing planned: No. This is a small open trial and findings will be too preliminary.
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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.
Martha C Thompson, PhD principal investigator
Boston University Charles River Campus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Focused Treatment (FFT) and Individual Treatment (IP) in people with Depression, run by Boston University Charles River Campus at 2 sites 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 3 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 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Adequate Depression Treatment Response (time frame: 3 months). 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 NCT01159041, which also lists 5 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 17 Jul 2026.