Modular Treatment for Preschool Anxiety

NCT02510391 | Unknown

• 1 other identifier: ACH-Preschool 2015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anxiety

Keywords

modular; anxiety; preschool; exposure and response prevention; Cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

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

  7-point clinician rating of improvement of psychopathology

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

Secondary Outcomes (3)

• Key Child Problems as assessed by Top Problems Assessment (TPA)

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

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

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

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

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

Study Arms (1)

PIPA

EXPERIMENTAL

Modularized treatment for anxiety in children ages 3-7 years old

Behavioral: PIPA

Interventions

PIPA BEHAVIORAL

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.

Also known as: Cognitive behavioral therapy, Exposure and response prevention, Parent training

PIPA

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adam Lewin: lead
• Johns Hopkins All Children's Hospital: collaborator

Study Sites (1)

Rothman Center for Pediatric Neuropsychiatry

St. Petersburg, Florida, 33701, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Adam B Lewin, Ph.D., ABPP

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 29, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

US (1)