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Depressive SymptomsNCT07020572

Improving Mood for Adolescents Through Teaming With End-Users in Routine Care (The iMATTER Project)

A study testing Brief Interpersonal Psychotherapy - Adolescent Skills Training (B-IPT-AST) and Services as usual (SAU) in people with Depressive Symptoms, run by Children's Hospital of Philadelphia at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This pilot randomized controlled trial will examine the feasibility, acceptability and preliminary efficacy of an adolescent depression prevention program, Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST), in primary care. Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Depressive Symptoms
What is being tested?
Brief Interpersonal Psychotherapy - Adolescent Skills Training (B-IPT-AST) and Services as usual (SAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited States
Study dates
20 Mar 2025to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • For Adolescent Participants
  • Adolescents ages 13 to 17 years.
  • Adolescents must be English-speaking.
  • Legal guardian permission (informed consent) and child consent/assent.
  • A score of 5-10 on the Patient Health Questionnaire 9-Item: Modified for Teens (PHQ-9-M) at the primary care well-visit.
  • Access to a phone, computer, or other electronic device that could be used for study activities
Show all 11Show fewer
  • For Legal guardian Participants
  • Legal guardian of an adolescents ages 13 to 17 years who scored 5-10 on the PHQ-9-M at the primary care well-visit.
  • Consent to participate.
  • English-speaking.
  • Access to a phone, computer, and/or tablet to complete remote evaluations.

Who cannot join

  • Exclusion criteria will be determined based on electronic health record (EHR) review, eligibility screening questions, the baseline evaluation, and any other interactions with the family.
  • Suicidal ideation or behaviors reported on the PHQ-9-M at their well-visit (score of 1 or higher on item 9 "In the past week, have you had thoughts that you would be better off dead, or of hurting yourself in some way?" and/or yes to either of the supplemental questions which ask, "Has there been a time in the past month when you have had serious thoughts about ending your life?" and "Have you ever, in your whole life, tried to kill yourself or made a suicide attempt?") based on medical record review. For the PHQ-9-M administered at baseline, adolescents who mark yes to the supplemental item about serious suicidal ideation in the past month ("Has there been a time in the past month when you have had serious thoughts about ending your life?") will be excluded.
  • Major medical illness, significant behavioral problems or intellectual or developmental disabilities that may interfere with the completion of all study procedures.
  • Youth may be excluded on a case-by-case basis if the EHR review, eligibility screener, baseline evaluation, or other interactions with the family suggests that the group program would not be appropriate.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Molly F Davis, PhD contact

2674250721

davismf@chop.edu

Jami F. Young, PhD contact

2674251328

youngjf@chop.edu

United States1 site, 1 recruiting
  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19146

    Molly F Davis, PhD, 267-425-0721, davismf@chop.edu

    Jami F Young, PhD, 267-425-1328, youngjf@chop.edu

    Recruiting

Other trials in United States

About this study

Official title: The iMATTER Project: Preventing Adolescent Depression in Pediatric Primary Care

This pilot randomized controlled trial will examine the feasibility, acceptability and preliminary efficacy of an adolescent depression prevention program, Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST), in primary care.

Read the detailed description

Depression is prevalent during adolescence and is associated with negative outcomes. Most adolescent depression prevention programs require significant time and resources. To reduce the research-to-practice gap, the present study will test an adapted version of an evidence-based depression preventive intervention, Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), to promote its implementation in primary care (PC). Specifically, a brief, scalable prevention program, Brief IPT-AST (B-IPT-AST), will be tested in a pilot randomized controlled trial in PC. The pilot randomized controlled trial will include adolescents ages 13-17 with subthreshold depression scores on a depression screener, the Patient Health Questionnaire 9-Item: Modified for Teens (PHQ-9-M), completed during an annual PC well-visit. Adolescents will be randomly assigned (2:1 allocation) to B-IPT-AST or services as usual (SAU). Members of the research team will deliver B-IPT-AST. Standardized measures for adolescents and legal guardians will be used to examine emotional outcomes (e.g., depression and anxiety symptoms). Standardized measures will be utilized to assess social processes (e.g., interpersonal conflict). All adolescents randomized to B-IPT-AST will complete a survey measuring acceptability of B-IPT-AST. Additionally, a subset of adolescents who participate in B-IPT-AST will be invited to participate in an hour-long qualitative interview to give feedback on their experiences with B-IPT-AST to inform any further modifications needed to enhance the program's feasibility and acceptability. Feasibility will also be assessed via recruitment and retention information and B-IPT-AST attendance logs.

Being tested
Brief Interpersonal Psychotherapy - Adolescent Skills Training (B-IPT-AST), Services as usual (SAU)
Medical subject headings
Depression

What participants receive

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

  • Brief Interpersonal Psychotherapy - Adolescent Skills Training (B-IPT-AST)Behavioural

    This is an adolescent depression prevention program consisting of 6 sessions (4 group and 2 individual sessions).

  • Services as usual (SAU)Behavioural

    Services as usual (SAU) involves any mental health services adolescents decide to receive in primary care or in the community. It is possible that adolescents in SAU may decide not to participate in any mental health services.

Study groups in NCT07020572
Study groupRoleWhat they receive
Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST)ExperimentalBrief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST) is an indicated group depression prevention program adapted from Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST). In B-IPT-AST, adolescents learn communication (e.g., using I statements, striking while the iron is cold) and interpersonal problem-solving strategies and apply these strategies to their relationships to decrease conflict, increase social support, and improve overall social functioning. B-IPT-AST consists of 1 individual pre-group sessions, 1 individual mid-group session, and 4 group sessions. Parents are invited to attend the mid-group session so the adolescents can apply the interpersonal strategies in a conversation with a parent.
Receives: Behavioral: Brief Interpersonal Psychotherapy - Adolescent Skills Training (B-IPT-AST)
Services as usual (SAU)Active comparatorServices as usual (SAU) involves any mental health services adolescents decide to receive in primary care or in the community. It is possible that adolescents in SAU may decide not to participate in any mental health services.
Receives: Behavioral: Services as usual (SAU)

What is being measured

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

  1. Acceptability: A self-report measure, the Attitude Towards Intervention Questionnaire (ATI)

    A self-report measure, the Attitude Towards Intervention Questionnaire (ATI), will be completed by adolescents to assess acceptability of Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST) following the intervention. The ATI includes 11 Likert scale items and one open-ended item for providing additional feedback. Likert scales vary by item but are generally 3- or 5-point scales (e.g., very helpful to very unhelpful). Each item is interpreted on its own (e.g., the percentage of teens who found B-IPT-AST very or a little helpful)

    Measured: 0-6 Weeks Post-Intervention

  2. Attendance

    The number of individual and group B-IPT-AST sessions that teens attend will be tracked in order to report on the average number of group sessions attended (out of 4) for the total sample as well as the average number of individual sessions (out of 2) attended across the sample

    Measured: Weekly during B-IPT-AST

  3. Retention

    To gauge feasibility, retention will be assessed by comparing the number of families who remain in the study through post-intervention to the number who consented.

    Measured: Baseline, 0-6 Weeks Post-Intervention

  4. Depression symptoms

    Change in depression symptoms will be measured by the Center for Epidemiologic Studies-Depression Scale (CES-D) which assesses the frequency of 20 depressive symptoms over the past week; CES-D scores range from 0 to 60 (scores of 16 or higher are considered elevated); higher scores indicate more depression symptoms

    Measured: Baseline, 0-6 Weeks Post-Intervention

  5. Depression symptoms

    Change in depression symptoms will also be measured by the Patient Health Questionnaire 9-Item: Modified for Teens (PHQ-9-M). The PHQ-9-M assesses depression symptoms over the past 2 weeks and includes 13 items, 9 of which are included in the total score. Total scores range from 0-27, with higher scores indicating more depression symptoms

    Measured: Baseline, 0-6 Weeks Post-Intervention

  6. Anxiety symptoms

    Change in anxiety symptoms will be assessed by the Screen for Child Anxiety Related Disorders (SCARED), a 41-item scale assessing symptoms corresponding to different anxiety disorders; the study team will examine total scores and the following subscales: panic, generalized anxiety disorder, and social anxiety; total scores range from 0-82 (25 or higher indicates clinical range); panic scores range from 0-26 (7 or higher indicates clinical range); generalized anxiety disorder scores range from 0-18 (scores of 9 or higher indicates clinical range); social anxiety scale ranges from 0-14 (scores 8 or higher indicate clinical range)

    Measured: Baseline, 0-6 Weeks Post-Intervention

Secondary outcomes (7)
  1. Internalizing and externalizing symptoms

    Changes in internalizing and externalizing symptoms will be assessed by the Pediatric Symptom Checklist (PSC-17), which will be completed by teens and caregivers; there is a total score (range of 0-34), internalizing subscale (0-24), externalizing subscale (0-20), and attention problems subscale (0-24); higher scores indicate more symptoms

    Measured: Baseline, 0-6 Weeks Post-Intervention

  2. Impairment (Child Report)

    Change in impairment will be measured via teen report on the Columbia Impairment Scale (CIS), 13-item scale of overall functioning; scores range from 0-52; a score of 15 or higher is considered elevated impairment; higher scores represent greater impairment

    Measured: Baseline, 0-6 Weeks Post-Intervention

  3. Impairment (Parent Report)

    Change in impairment will be measured via parent report on the Columbia Impairment Scale (CIS), 13-item scale of overall functioning; scores range from 0-52; a score of 15 or higher is considered elevated impairment; higher scores represent greater impairment

    Measured: Baseline, 0-6 Weeks Post-Intervention

  4. Perspective-taking

    Changes in perspective taking will be measured by the Interpersonal Reactivity Index (IRI), a 7-item perspective-taking scale; scores range from 0-28 with higher scores representing more perspective taking

    Measured: Baseline, 0-6 Weeks Post-Intervention

  5. Social functioning

    Changes in social functioning will be assessed by the Social Adjustment Scale-Self Report (SAS-SR), a 23-item scale of functioning in school (scores range from 6-30), with friends (scores range from 9-45), with family (scores range from 6-30), and dating (scores range from 2-10); a total score can also be computed (scores range from 23-115); higher scores indicate more difficulties in social functioning

    Measured: Baseline, 0-6 Weeks Post-Intervention

  6. Parent-child conflict (child report)

    Changes in parent-child conflict will be assessed via teen report on the Conflict Behavior Questionnaire (CBQ), a 20-item questionnaire measuring conflict and negative communication between parents and adolescents; scores range from 0-20; higher scores indicate more conflict

    Measured: Baseline, 0-6 Weeks Post-Intervention

  7. Parent-child conflict (parent report)

    Changes in parent-child conflict will be assessed via parent report on the Conflict Behavior Questionnaire (CBQ), a 20-item questionnaire measuring conflict and negative communication between parents and adolescents; scores range from 0-20; higher scores indicate more conflict

    Measured: Baseline, 0-6 Weeks Post-Intervention

Timeline

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

  1. First posted13 Jun 2025
  2. Study start20 Mar 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07020572
Sponsor's protocol ID
24-023018
Status last verified
Jun 2026
First submitted
6 Jun 2025
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Brief Interpersonal Psychotherapy - Adolescent Skills Training (B-IPT-AST) and Services as usual (SAU) in people with Depressive Symptoms, run by Children's Hospital of Philadelphia 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 11 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Molly F Davis, PhD (2674250721, davismf@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability: A self-report measure, the Attitude Towards Intervention Questionnaire (ATI) (time frame: 0-6 Weeks Post-Intervention). The study lists 6 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 15 Jun 2026.

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