Improving Access to Child Anxiety Treatment (IMPACT)
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|ClinicalTrials.gov Identifier: NCT03528109|
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : September 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obsessive-Compulsive Disorder Anxiety Disorders Pediatric Disorder Cognitive Behavior Therapy Exposure Therapy Anxiety OCD Phobia Agoraphobia Generalized Anxiety Generalized Anxiety Disorder Selective Mutism Separation Anxiety Social Anxiety Social Anxiety Disorder Panic Disorder||Behavioral: Exposure Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||333 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison of Patient-Centered Versus Provider-Centered Delivery of Cognitive Behavioral Treatment (CBT) for Pediatric Anxiety and Obsessive Compulsive Disorder (OCD)|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||April 1, 2023|
|Estimated Study Completion Date :||May 1, 2024|
Experimental: patient-centered CBT
60 minute office-based exposure therapy with a PhD psychologist once per month and a 90 minute community-based CBT with a mobile exposure coach three times per month for a total of four visits per month (once per week)
Behavioral: Exposure Therapy
A type of Cognitive Behavioral Therapy shown to be effective in the treatment of pediatric OCD and anxiety
Active Comparator: Provider-centered
60 minute office-based exposure therapy with a PhD psychologist four times per month (once per week)
Behavioral: Exposure Therapy
A type of Cognitive Behavioral Therapy shown to be effective in the treatment of pediatric OCD and anxiety
- Children's Yale-Brown Obsessive-Compulsive Scale [ Time Frame: In-treatment and follow-up (6-12 months) ]The CY-BOCS is a measure of obsessive compulsive symptoms and severity. The Obsession Rating Scale measures 5 domains of obsessional severity on a scale from 0 (no impairment) to 4 (extreme impairment.) The Compulsion Rating Scale measures 5 domains of compulsion severity on a scale from 0 (no impairment) to 5 (extreme impairment.) The total range of OCD severity is reported on a scale from 0-40, with a higher score indicating greater severity.
- Pediatric Anxiety Rating Scale [ Time Frame: In-treatment and follow-up (6-12 months) ]The PARS is a measure of anxiety symptoms and severity. The Anxiety Severity Items are 7 questions meant to assess the frequency of anxiety symptoms and associated impairment. Items are measured on a scale from 0 (none) to 5 (extreme).The total range of anxiety severity is reported on a scale from 0-35, with a higher score indicating greater severity.
- Client Satisfaction Questionnaire-8 [ Time Frame: In-treatment and follow-up (6-12 months) ]The CSQ-8 measures consumer satisfaction with mental health services; satisfaction is measured using 8 items on a scale from 1 (Poor) to 4 (Excellent). Total satisfaction ranges from 8-32, with a high score indicating greater satisfaction.
- Clinical Global Impression Scales [ Time Frame: In-treatment and follow-up (6-12 months) ]The CGI is a clinician-rated measures of global severity and improvement. The Severity of illness scale reports the severity of current symptoms on a scale from 1 (not at all ill) to 7 (among the most extremely ill patients.) The Global Improvement Scale tracks improvement since treatment initiation on a scale from 1 (very much improved) to 7 (very much worse). The highest possible score on either scale is 7, indicating extreme severity or worse treatment outcome.
- Child Sheehan Disability Scale [ Time Frame: In-treatment and follow-up (6-12 months) ]The CSDS measures the extent to which anxiety symptoms interfere with functioning. The Disability Scale measures the degree to which anxiety impacts school, social, and home life on a scale from 0 (Not at all) to 10 (very, very much.) Total anxiety-related impairment ranges from 0-30, with higher scores indicating greater impairment.
- Homework Compliance Form [ Time Frame: Up to 6 months ]The measure tracks both the quality and quantity of homework completed between treatment sessions. This form has been used previously by our research group in large-scale treatment trials, and has been helpful in determining barriers to homework completion.
- Exposure Guide [ Time Frame: Up to 6 months ]The Exposure Guide is a exposure therapy fidelity/quality tool completed by study therapists. This tool collects information regarding the use of specific therapeutic tools during exposures.
- Therapeutic Alliance Scales for Caregivers and Parents (TASCP) [ Time Frame: Up to 6 months ]The TASCP is a 12-item measure of therapeutic alliance between a caregiver and his/her child's therapist. This measure assesses the bond and collaboration between caregiver and therapist. Each item is rated using a scale from 0: "not true" to 4: "very much true."
- Therapeutic Alliance Scales for Children-Revised (TASC-r) [ Time Frame: Up to 6 months ]75 The TASC-r is a 12-item measure of therapeutic alliance between a child and his/her therapist. This measure assesses the degree of affective bond between child and therapist, as well as amount of therapeutic task collaboration. Each item is rated using a scale from 0: "not true" to 4: "very much true."
- Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) [ Time Frame: In-treatment and follow-up (6-12 months) ]The PQ-LES-Q is a 13-item measure of child functioning in life that uses a 5-point ratings scale, with higher scores indicating better quality of life. This measure has both parent and child versions, assessing the same items from both child and parent perspectives. The measure assesses quality of the child's life in a variety of domains.
- Top Problems Assessment (TPA) [ Time Frame: In-treatment and follow-up (6-12 months) ]The TPA is designed to independently solicit from youth and parent the top 3 problems they feel are most important to address in treatment. This is an idiographic measure of impairment that is driven by the individual needs and desires of the consumer. Respondents rate how much each problem bothers them from 0 ("not at all") to 10 (very, very much).
- Caregiver Strain Questionnaire (CSQ) [ Time Frame: In-treatment and follow-up (6-12 months) ]The CSQ assesses parent perceptions of the extent to which caring for a child with emotional problems affects several domains, including family life and relationships, demands on time, financial strain, disruption of social life, worry, guilt, and fatigue. This is a 21-item self-report measure that calls for parents to rate the extent of strain for each item using a 0 ("not at all") to 4 ("very much") scale.
- Barriers to Treatment Questionnaire - Parent Version (BTQ-P) [ Time Frame: In-treatment and follow-up (6-12 months) ]The BTQ-P is a 28-item measure adapted from the BTQ to assess parent perceptions of barriers to accessing treatment for their child's anxiety. The measure is completed at the outset of treatment and assesses such domains as logistic and financial barriers, stigma, and aspects of treatment. Items are rated on a 0 ("not at all true") to 2 ("mostly true") scale.
- Pediatric Accommodation Scale-Parent Report (PAS-PR) [ Time Frame: In-treatment and follow-up (6-12 months) ]The PAS-PR is a 5-item questionnaire assessing the frequency and interference associated with accommodating the child's anxiety. Each item is followed by a series of common examples to illustrate the principle of accommodation for parents. Responses for frequency include 0 (never), 1 (rarely), 2 (occasionally), 3 (often), and 4 (always). Response options for interference due to accommodation include 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (extreme).
- Randomization Debrief [ Time Frame: Administered at baseline ]We will record reactions from caregivers and child to treatment assignment using this clinician-rated measure. It includes capturing both verbatim responses from caregivers and child, as well as asking for interviewer impressions reactions from caregivers and child to treatment group assignment following randomization. The clinician also records the likelihood that the family will remain in the study and adhere to study protocols.
- Treatment Expectancy [ Time Frame: Administered at baseline ]This measure is a 3-item self-report questionnaire that captures parental beliefs about the efficacy about each treatment condition (office-based or home/community-based) using a scale from 1:"I expect my child will be very much improved," to 7: "I expect my child will be very much worse." The parent is also asked to select which treatment option would be best for their family. There is also a patient version of this measure used to capture patient beliefs about the efficacy about each treatment condition (office-based or home/community-based) using the same scale. The patient is asked to select which treatment option they believe would be best for them and their family. The patient version of this measure will be completed by youth 12+.
- The Social Responsiveness Scale, Second Edition (SRS-2) [ Time Frame: Administered at baseline and at discharge (up to 6-months) ]The SRS-2 is a 65-item self-report measure administered to caregivers or teachers to assess their perception of the presence of a child's social impairment. This measure is used to evaluate children aged 4-18 years old. Items are rated on a scale from 1 ("not true") to 4 ("almost always true").
- Affective Reactivity Index - Parent Version (ARI-P) [ Time Frame: In-treatment and follow-up (6-12 months) ]The ARI-P is a 7-item parent report questionnaire assessing child's irritability. The items are each given a rating of: "not true," "somewhat true" or "certainly true".
- Affective Reactivity Index - Self Report (ARI-S) [ Time Frame: In-treatment and follow-up (6-12 months) ]The ARI-S is a 7-item self-report report questionnaire assessing irritability. The items are each given a rating of: "not true," "somewhat true" or "certainly true".
- Distress Intolerance Index [ Time Frame: In-treatment and follow-up (6-12 months) ]The Distress Intolerance Index is a 10-item self-report report questionnaire assessing the inability to tolerate negative somatic and emotional states. Items are rated on a 5-point scale from "very little" (0) to "very much".
- Parent Accommodation Scale (PAS) [ Time Frame: In-treatment and follow-up (6-12 months) ]The PAS is a 12-item questionnaire assessing the frequency of and beliefs about parental accommodation. The frequency of parental accommodation is measured on a scale from "Never/Almost Never" (0), to "Always/Almost Always" (3). The beliefs about parental accommodation are measured on a scale from "Strongly Disagree" (0), to "Strongly Agree" (3).
- Feedback Forms - Caregiver and Child Versions [ Time Frame: Administered only at discharge, up to 6-months into study ]The feedback form is a 3-item self-report questionnaire that asks caregivers or child which treatment group their family was in and for open-ended feedback about their experience in the study (i.e. what did they really like, what would they change, general suggestions/ comments). All responses on this survey are received anonymously. Caregivers and children complete separate feedback forms. Children 8+ will complete the child version of this measure.
- End of Treatment Form [ Time Frame: Administered only at discharge, up to 6-months into study ]This form captures whether the patient ended treatment before or at 6 months, as well as the reasons for discontinuation (e.g., scheduling, transportation, financial, treatment fit, symptoms) that apply. This form also gathers information about whether referrals were provided to the family upon study discharge.
- Sharing Study Findings [ Time Frame: Administered only at discharge, up to 6-months into study ]This 7-item measure asks for participants' caregivers to discuss to whom they would like the findings of the study to be disseminated (i.e., local policy makers, educators, etc.). Additionally, it asks for information on how they would like findings to be shared (i.e., via social media, presentations, etc.) as well as caregivers to share highlights of their experience in the study.
- Treatment Attendance [ Time Frame: Up to 6 months ]We will record the rate of session reschedules, cancellations and no-shows, along with the overall number of sessions attended. We will also document the reason why a scheduled appointment does not occur using the Treatment Cancellation Form.
- Reasons for Treatment Discontinuation form [ Time Frame: Administered only at discharge, up to 6-months into study ]This is a case record form that documents any change in patient status (e.g., drop-out and premature termination) and the reasons for such changes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528109
|Contact: Jennifer Freeman, PhDfirstname.lastname@example.org|
|Contact: Elena Schiavone, BAemail@example.com|
|United States, Rhode Island|
|Riverside, Rhode Island, United States, 02915|
|Contact: Jennifer Freeman, PhD 401-432-1057 firstname.lastname@example.org|
|Contact: Elena Schiavone, BA 401-432-1635 email@example.com|
|Principal Investigator:||Jennifer Freeman, PhD||Warren Alpert Medical School of Brown University|