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AnxietyNCT02510391

Modular Treatment for Preschool Anxiety

A study testing PIPA in people with Anxiety, run by Adam Lewin at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This nonrandomized pilot study is investigating the efficacy of a modularized treatment for anxiety in children ages 3-7 years old. Eligibility is determined at a baseline assessment, followed by a second baseline assessment one month later. Read more about this study

Who is it for?
Ages 3 to 7 years
Conditions the study is for
Anxiety
What is being tested?
PIPA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
Oct 2015to Dec 2020
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 7 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children aged 3 to 7 years
  • Anxiety-based concerns rated as a top problem on the Top Problems Assessment at initial assessment.

Who cannot join

  • Report or evidence of severe intellectual disability or level 3 autism spectrum disorder (ASD) without accompanying intellectual/language impairment (mild ASD is not exclusionary).
  • Presence of clinical features requiring a higher level of care (inpatient or partial hospital treatment).
  • Unwillingness of parents to accompany their children for multiple study visits;
  • Presence of a significant and/or unstable medical illness that might lead to hospitalization during the study.
  • Initiation of an antidepressant within the 12 weeks preceding study enrollment, antipsychotic within 8 weeks prior to study enrollment, changes in established psychotropic medications within 8 weeks before study enrollment, or any change in alternative medications that might have behavioral effects within 6 weeks prior to study baseline assessment. Youth may remain stable on medications during the study.
  • Ongoing reports of abuse/neglect or trauma reported as a primary concern.
  • Extreme aggression/risk behaviors (e.g., harming animals, fire starting, violence) suggestive of conduct disorder trajectory.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Rothman Center for Pediatric Neuropsychiatry

    St. Petersburg, Florida, 33701

Other trials in United States

About this study

This nonrandomized pilot study is investigating the efficacy of a modularized treatment for anxiety in children ages 3-7 years old. Eligibility is determined at a baseline assessment, followed by a second baseline assessment one month later. The treatment protocol, Parent-training Intervention for Preschoolers with Anxiety (PIPA), is flexible and allows for individualized treatments based on a treatment algorithm, ensuring that sessions address the most pressing clinical needs of each child. Treatment consists of weekly 60-minute sessions delivered over the course of 12 weeks. Symptom change is tracked weekly during brief phone assessments and a post-treatment assessment will occur following the final treatment session, approximately 12 weeks after starting treatment. Finally, all participants will complete two follow-up assessments, occurring 1-month and 6-months after the final treatment session.

Read the detailed description

Early childhood mental illness is a growing public health concern, and can persist into adolescence and adulthood if left untreated. Anxiety disorders are among the most common psychiatric illnesses in preschool aged youth and place youth at significantly higher risk for anxiety, depression, substance abuse, conduct problems, and diminished academic/occupational and social/relational functioning later in life. Accordingly, there is increasing emphasis on early identification and intervention, before symptoms become entrenched to mitigate a trajectory towards longstanding impairment.

Unfortunately, empirically supported treatments for preschoolers with anxiety are limited. The few studies to date have tended to focus on relatively homogeneous samples whose symptoms resemble those in adults (e.g., worries and fears). Anxiety can present in similar ways to adult anxiety, however can also present more broadly in young children. Young children with anxiety may also present with extreme rigidity, sensory hypersensitivity, 'meltdowns'/emotional dysregulation/temper tantrums, ritualistic/routine oriented behavior, and oppositional behavior in some context. By focusing narrowly, treatments have not been adapted for the full range of anxiety presentations in early childhood.

Therefore, the proposed study evaluates a modular, parent-driven psychotherapy developed for preschool aged youth (3-7 years) with diagnostic levels of anxiety, as well as anxiety symptoms dimensionally. The treatment program, Parent-training Intervention for Preschoolers with Anxiety (PIPA), is based on empirically supported behavioral and parent-training principles as well as the investigators' recently published pilot study of preschoolers with obsessive compulsive disorder. Sixty youth will be treated during the study. PIPA focuses on exposure and response prevention therapy (E/RP) in the context of behavioral parent training, each of which have efficacy in youth with anxiety, including high functioning autism spectrum disorders (ASD). Certain parenting responses (e.g., overprotection, critical responding, accommodation of anxiety symptoms and avoidance) have been implicated in the etiology and maintenance of pediatric anxiety disorders and, in addition to E/RP, this intervention will target behavioral parent training and unhelpful parenting practices to support long-term outcomes.

In addition, this study will investigate one surrogate biomarker of anxiety in young children, fear conditioning (or more specifically, resistance to extinction). Behavioral treatment of anxiety, including the proposed PIPA intervention, relies on principles of extinction. Children and adults with anxiety disorders have been shown to have poorer fear extinction; however, there are few studies in young children examining this phenomenon. The potential to understand fear extinction in young children has implications for improving treatment efficacy and altering the negative trajectory of youth with anxiety disorders.

Eligibility will be determined at a baseline assessment. A second baseline assessment will occur one month later for those that qualify. This assessment will be used to control for symptom change due to the natural passage of time. Treatment will be delivered over 12 weeks and will include weekly 60-minute sessions. A brief phone call with an assessor each week will be used to track symptom change during treatment, and a post-treatment assessment will be conducted following the final treatment session, approximately 12 weeks later. Follow-up assessments will occur 1-month and 6-months following the final treatment session.

Conditions
Anxiety
Being tested
PIPA
Keywords
modular, anxiety, preschool, exposure and response prevention, Cognitive behavioral therapy
Medical subject headings
Anxiety Disorders

What participants receive

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

  • PIPABehavioural

    Also called Cognitive behavioral therapy, Exposure and response prevention, Parent training

    Parent-training Intervention for Preschoolers with Anxiety (PIPA) is a behaviorally based modular treatment program for emotional and behavioral problems in young children. 12 sixty minute sessions will be delivered weekly. This intervention employs a modular format following a treatment algorithm in which therapy modules are selected by the therapist and supervisor on a session-by-session basis to address the most pressing clinical needs. Minimum session requirements for parent training/education and fear hierarchy/exposure are set to insure adequate dose of core exposure and response prevention for anxiety across cases.

Study groups in NCT02510391
Study groupRoleWhat they receive
PIPAExperimentalModularized treatment for anxiety in children ages 3-7 years old
Receives: Behavioral: PIPA

What is being measured

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

  1. Anxiety Improvement as assessed by Clinical Global Impression- Improvement (CGI-I)

    7-point clinician rating of improvement of psychopathology

    Measured: Rating after the final therapy session, approximately 12 weeks after starting treatment.

Secondary outcomes (3)
  1. Key Child Problems as assessed by Top Problems Assessment (TPA)

    obtains ratings of severity of the top three problems as identified by parent report

    Measured: Assess at end of treatment (approximately 12 weeks from start), 1-month following end of treatment, 6-months after completion of treatment

  2. Child Diagnostic Presence as measured by the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS)

    Semi-structured diagnostic interview used to assess possible diagnoses via parent report

    Measured: Assess at end of treatment (approximately 12 weeks from start), 1-month following end of treatment, 6-months after completion of treatment

  3. Anxiety Severity as measured by the Clinical Global Impression- Severity (CGI-S)

    7-point clinician rating of severity of psychopathology

    Measured: Assess at end of treatment (approximately 12 weeks from start), 1-month following end of treatment, 6-months after completion of treatment

Timeline

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

  1. First posted29 Jul 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionMar 2020
  4. Study completionDec 2020 (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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02510391
Sponsor's protocol ID
ACH-Preschool 2015
Status last verified
Apr 2020
First submitted
15 Jul 2015
Last updated
24 Apr 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing PIPA in people with Anxiety, run by Adam Lewin 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 7 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: status not confirmed, as of the sponsor's last update on 24 Apr 2020. 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?

Results are not available in the source record.

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?

Anxiety Improvement as assessed by Clinical Global Impression- Improvement (CGI-I) (time frame: Rating after the final therapy session, approximately 12 weeks after starting treatment.). 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 24 Apr 2020.

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