Anxiety DisordersNCT03255122
Technology and Early Anxiety Treatment
A study testing I-CALM and Delayed I-CALM in people with Anxiety Disorders, run by Florida International University at 1 site in United States.
Trial summary
The goal of the study is to evaluate the efficacy of an Internet-delivered format of an evidence-based CBT treatment for early social anxiety disorder (Coaching Approach behavior and Leading by Modeling, or the CALM Program) in which therapists and families meet in real-time via videoconferencing and parent-child… Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- I-CALM and Delayed I-CALM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2016to 22 Apr 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 3-8 years old, and at least one primary caregiver
- Child has diagnosis of social anxiety disorder (as assessed in pre-treatment assessment).
- Child and parent both speak either English or Spanish fluently
- Family's home is equipped with computing device and high-speed internet
Who cannot join
- Child has emotional/behavioral problem more impairing than difficulties captured by an anxiety disorder diagnosis.
- Child receiving medication or other psychotherapy to manage emotional difficulties
- History of severe physical or mental impairments (e.g., intellectual disability, deafness, blindness, pervasive developmental disorder) in child or participating caregiver(s)
- Child is a ward of the state
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
Official title: Harnessing Technology to Extend the Reach of Supported Care for Families Affected by Early Child Social Anxiety
The goal of the study is to evaluate the efficacy of an Internet-delivered format of an evidence-based CBT treatment for early social anxiety disorder (Coaching Approach behavior and Leading by Modeling, or the CALM Program) in which therapists and families meet in real-time via videoconferencing and parent-child interactions are broadcast from the family's home via a webcam while therapists provide bug-in-the-ear coaching from a remote site. In a randomized controlled trial (RCT), the proposed work will evaluate 40 youth with social anxiety disorder (ages 3-8); 20 will receive the CALM Program over the Internet (I-CALM) and 20 will be assigned to a waitlist control and will complete a course of I-CALM after the waitlist period. Outcomes will be assessed via structured diagnostic interviews and parent-report questionnaires.
Read the detailed description
The goal of the study is to evaluate the efficacy of an Internet-delivered format of an evidence-based CBT treatment for early child social anxiety disorder (Coaching Approach behavior and Leading by Modeling, or the CALM Program) in which therapists and families meet in real-time via videoconferencing and parent-child interactions are broadcast from the family's home via a webcam while therapists provide bug-in-the-ear coaching from a remote site. In a randomized controlled trial (RCT), the proposed work will evaluate 40 youth with social anxiety disorder (ages 3-8); 20 will receive the CALM Program over the Internet (I-CALM) and 20 will be assigned to a waitlist control, followed by I-CALM treatment.
SPECIFIC AIMS:
- Aim 1: To evaluate I-CALM efficacy for reducing early child social anxiety symptoms and related impairments and for improving child and parent quality of life.
- Aim 2: To examine the extent to which I-CALM helps families overcome traditional barriers to effective care, including geographic barriers and regional professional workforce shortages in social anxiety expert care.
- Aim 3: To evaluate the feasibility, acceptability, and satisfaction of I-CALM from the perspective of treated\ families, and lay the foundation for a large Florida statewide implementation of I-CALM for early social anxiety.
RATIONALE: Despite progress in supported programs for child social anxiety disorder, gaps persist between treatment in specialty clinics and services broadly available in the community. Although considerable advances show social anxiety is treatable when appropriate CBT is available, barriers interfere with the broad provision of quality care. Few sufferers receive services, and those who do receive services do not necessarily receive evidence-based care. Many U.S. counties have no psychologist, psychiatrist, or social worker, let alone professionals trained in supported social anxiety treatments. When effective programs are available, transportation issues constrain access, with large proportions of patients reporting that services are too far away or they have no way to get to a clinic. Expert providers cluster around metropolitan regions and major academic hubs, leaving considerable numbers of youth without access to supported service options. Youth from low-income or remote and rural communities are particularly unlikely to receive appropriate care. High rates of stigma-related beliefs further constrain service utilization, with many reporting negative attitudes about visiting a mental health clinic.
An Internet-delivered, real-time intervention for the remote treatment of early child social anxiety disorder has the potential to meaningfully extend the reach of effective social anxiety treatment for underserved youth and can serve as the critical foundation upon which to build a larger-scale statewide implementation of early social anxiety treatment. Moreover, treating youth in their homes can overcome stigma-related concerns that interfere with families attending services at a psychiatric clinic, and treatment gains may be more generalizable and ecologically valid as services are provided to youth in their natural settings.
SERVICES: The CALM Program (Coaching Approach behavior and Leading by Modeling) was developed as a developmentally compatible intervention to treat anxiety disorders in children below age 8. The CALM Program is an adaptation of Parent-Child Interaction Therapy (PCIT), which was initially developed to treat early behavior problems, and incorporates a family-based approach to early child anxiety. Whereas effective treatment for older socially anxious youth requires a set of cognitive abilities that younger children typically do not fully possess, it has been demonstrated that adaptations of PCIT-which do not target children directly, but rather work to reshape the primary contexts of child development in order to treat child anxiety-can offer more developmentally compatible approaches for intervening with early social anxiety. The CALM Program is a parent-focused treatment that educates families about social anxiety and teaches parents skills to effectively reinforce their children's brave social behavior and coaches the use of these skills during in-session parent-child interactions. The treatment emphasizes live, bug-in-the-ear coaching of parents during in vivo exposure sessions. Child symptoms are targeted by reshaping interaction patterns associated with the maintenance of child anxiety and by reducing parental accommodation of child bids to avoid social situations.
Traditionally, the CALM therapist is situated behind a one-way mirror and unobtrusively provides real-time feedback to parents through a parent-worn earpiece. It has been suggested that PCIT-based approaches are particularly amenable to a web format given that by design the therapist conducts live observation and feedback from another room via a parent-worn bug-in-the-ear device. That is, even in standard clinic-based CALM, the therapist is predominantly separated from the family in order to foster naturalistic family interactions and child behavior. Despite progress in the development of the CALM Program for social anxiety, and progress in the field of behavioral telehealth, research has yet to evaluate the efficacy of an Internet-delivered format of the CALM Program (I-PCIT) for extending the accessibility of treatment. I-CALM families will receive treatment using secure and encrypted videoconferencing software, and parents will receive live coaching via a Bluetooth earpiece. Independent evaluators will conduct diagnostic interviews, collect parent-report forms, and conduct structured observations at baseline, post-treatment, and 6-months follow-up.
OUTCOMES: Independent evaluators (IEs) masked to participant condition assignment will conduct diagnostic interviews, collect parent-report forms, and conduct structured observations at baseline, post-treatment, and 6-month follow-up.
- Conditions
- Anxiety Disorders
- Being tested
- I-CALM, Delayed I-CALM
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-CALMBehavioural
Families receiving I-CALM will immediately receive a videoconferencing-based, Internet-delivered format of an evidence-based CBT treatment for early child social anxiety disorder (Coaching Approach behavior and Leading by Modeling, or the CALM Program; Puliafico, Comer, \& Albano, 2013) in which therapists and families meet in real-time via videoconferencing and parent-child interactions are broadcast from the family's home via a webcam while therapists provide bug-in-the-ear coaching from a remote site. Parents are taught and guided in how to coach their young anxious child to engage in brave, approach behavior.
Delayed I-CALMBehavioural
Families receiving Delayed I-CALM will participate in a waitlist period, and then will complete the I-CALM treatment program.
| Study group | Role | What they receive |
|---|---|---|
| Immediate treatment | Experimental | Individuals in this condition will immediately receive I-CALM treatment, which draws on videoconferencing to remotely deliver real time cognitive-behavioral therapy for early child anxiety to families in their home. Receives: Behavioral: I-CALM |
| Waitlist | Other | Individuals in Waitlist will participate in an initial waitlist condition, and then after post-waitlist assessment will be offered the I-CALM intervention. Accordingly families in this condition receive Delayed I-CALM. Receives: Behavioral: Delayed I-CALM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impressions Scales - Severity and Improvement (CGI-S/I)
CGI-S/I is the most widely used clinician-rated measure of treatment-related changes in functioning (Guy \& Bonato, 1970) and will be completed by IEs in the present study. The CGI-S score rates illness severity on a 7-point scale, ranging from 1 ("normal") to 7 ("among the most severely ill patients"). The CGI-I rates clinical improvement on a 7-point scale, ranging from 1 ("very much improved") to 7 ("very much worse").
Measured: 5 minutes
Secondary outcomes (10)
Children's Global Assessment Scale
The Children's Global Assessment Scale (CGAS; Shaffer et al., 1983) is a widely used measure of overall child disturbance, providing a clinician-rated index of functioning. Scores range from 0-100, with lower scores indicating greater functional impairments.
Measured: 5 minutes
Child Anxiety Impact Scale
The Child Anxiety Impact Scale (CAIS) is a brief parent-report measure of anxiety-related functional impairment, and has shown strong psychometric properties (Langley et al., 2014).
Measured: 5 minutes
Family Burden Assessment Scale
The Family Burden Assessment Scale (BAS) is a brief measure of subjective and objective consequences of disorder/illness on primary caretakers.
Measured: 5 minutes
Family Accommodation Checklist and Interference Scale
The Family Accommodation Checklist and Impact Scale (FACLIS; Thompson-Hollands et al., 2014) is a parent report measure of the extent to which parents are changing their behavior in attempts to prevent or reduce child distress, and has shown strong validity and reliability in samples of youth with anxiety disorders (e.g., Thompson-Hollands et al., 2014).
Measured: 10 minutes
Family Accommodation Scale- Anxiety
The Family Accommodation Scale-Anxiety (FASA) asks parents to rate the frequency of their participation in their child's anxiety-related behaviors (e.g., assisting avoidance, providing reassurance) and modification of family routines because of child anxiety. The FASA has demonstrated strong reliability and validity (Lebowitz et al., 2013).
Measured: 10 minutes
Working Alliance Inventory
The Working Alliance Inventory (Horvath, 1994) is a 36-item assessment of perceptions of the quality of therapeutic rapport and collaboration throughout treatment. Therapy participants and therapists will both rate each item independently on a scale from 1 (Never) to 7 (Always) to characterize their perceptions of the affective bond between the client and therapist and the extent of their agreement about the goals and tasks of treatment. The WAI has demonstrated favorable psychometric support (Horvath \& Greenberg, 1989). In the present study, we will include posttreatment total scores from Mother-reports about their perceived relationship with the therapist and from Therapist-reports about their perceived relationship with the child.
Measured: 10 minutes
Client Satisfaction Questionnaire
The Client Satisfaction Questionnaire (CSQ-8; Larsen, Attkisson, Hargreaves \& Nguyen, 1979) is a generic 8-item assessment of consumer satisfaction with services received (e.g., "How would you rate the quality of the services you received?" and "If a friend were in need of similar help, would you recommend our program to him or her?"). Each item is rated on a 4-point scale and a total score is used to reflect overall satisfaction with treatment. Mother-reports at posttreatment will included in the present study. The CSQ-8 is one of the most frequently used measures of satisfaction with services and has demonstrated strong psychometric properties across a range of treatment populations.
Measured: 3 minutes
Child Behavior Checklist
The Child Behavior Checklist (CBCL) is a standardized instrument for assessing behavioral and emotional problems, demonstrating very strong psychometric properties. Caregivers rate each item as 0 (not true), 1 (somewhat or sometimes true), or 2 (very true or often true). Empirically based scales, normed for age and gender, are generated, including three broadband dimensions (internalizing problems, externalizing problems, and total problems) as well as a number of syndrome scales and DSM-oriented scales; t-scores below 65 reflect normative functioning. For the present purposes, we will included the internalizing problems scale and the anxiety problems scale. Parents of participants ages five and below will complete the CBCL 1.5-5 (Achenbach \& Rescorla, 2000) and parents of youth six and older completed the CBCL 6-18 (Achenbach, 2001).
Measured: 25 minutes
Anxiety Disorders Interview Schedule for Children (ADIS-C/P)
The ADIS is is a semi-structured diagnostic interview that assesses child psychopathology in accordance with DSM criteria.
Measured: 2 hours
Spence Children's Anxiety Scale
Spence Children's Anxiety Scale for Parents (SCAS-P; Spence, 1999)-a 39-item parent-report of child anxiety in youth ages 6-18-will be used to assess child anxiety in families with 6-8 year-olds. The SCAS-P has demonstrated good internal consistency, convergent validity, and discriminant validity (Nauta et al., 2004). The Total Score of the Preschool Anxiety Scale-Revised (PAS-R; Spence et al., 2008)-a 34-item parent-report of anxiety among preschoolers-will be used to assess child anxiety in families with 3-5 year-olds. The PAS-R is a downward extension of the SCAS-P for younger children and has demonstrated good construct validity and reliability (Spence et al., 2001).
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start3 Nov 2016
- Primary completion22 Jan 2020
- Study completion22 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies 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
- Model description
- Families are randomly designed to receive either immediate treatment (I-CALM) or waitlist and then I-CALM
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- Andrew Kukes Foundation for Social Anxiety
- Responsible party
- Principal investigator, Jonathan S. Comer, Florida International University
- Investigators
- Jonathan S Comer, PhD, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255122
- Sponsor's protocol ID
- IRB-16-0182
- Status last verified
- Jul 2020
- First submitted
- 20 Mar 2017
- Last updated
- 2 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carpenter AL, Puliafico AC, Kurtz SM, Pincus DB, Comer JS. Extending parent-child interaction therapy for early childhood internalizing problems: new advances for an overlooked population. Clin Child Fam Psychol Rev. 2014 Dec;17(4):340-56. doi: 10.1007/s10567-014-0172-4.
PubMed 25212716Comer, J.S. (2015). Introduction to the special section: Applying new technologies to extend the scope and accessibility of mental health care. Cognitive and Behavioral Practice, 22, 253-257. doi:http://dx.doi.org/10.1016/j.cbpra.2015.04.002
Comer JS, Barlow DH. The occasional case against broad dissemination and implementation: retaining a role for specialty care in the delivery of psychological treatments. Am Psychol. 2014 Jan;69(1):1-18. doi: 10.1037/a0033582. Epub 2013 Aug 5.
PubMed 23915401Comer JS, Blanco C, Hasin DS, Liu SM, Grant BF, Turner JB, Olfson M. Health-related quality of life across the anxiety disorders: results from the national epidemiologic survey on alcohol and related conditions (NESARC). J Clin Psychiatry. 2011 Jan;72(1):43-50. doi: 10.4088/JCP.09m05094blu. Epub 2010 Aug 24.
PubMed 20816036Comer JS, Furr JM, Cooper-Vince CE, Kerns CE, Chan PT, Edson AL, Khanna M, Franklin ME, Garcia AM, Freeman JB. Internet-delivered, family-based treatment for early-onset OCD: a preliminary case series. J Clin Child Adolesc Psychol. 2014;43(1):74-87. doi: 10.1080/15374416.2013.855127. Epub 2013 Dec 2.
PubMed 24295036Comer JS, Furr JM, Cooper-Vince C, Madigan RJ, Chow C, Chan P, Idrobo F, Chase RM, McNeil CB, Eyberg SM. Rationale and Considerations for the Internet-Based Delivery of Parent-Child Interaction Therapy. Cogn Behav Pract. 2015 Aug 1;22(3):302-316. doi: 10.1016/j.cbpra.2014.07.003.
PubMed 26120268Comer JS, Furr JM, Kerns CE, Miguel E, Coxe S, Elkins RM, Carpenter AL, Cornacchio D, Cooper-Vince CE, DeSerisy M, Chou T, Sanchez AL, Khanna M, Franklin ME, Garcia AM, Freeman JB. Internet-delivered, family-based treatment for early-onset OCD: A pilot randomized trial. J Consult Clin Psychol. 2017 Feb;85(2):178-186. doi: 10.1037/ccp0000155. Epub 2016 Nov 21.
PubMed 27869451Comer JS, Furr JM, Miguel EM, Cooper-Vince CE, Carpenter AL, Elkins RM, Kerns CE, Cornacchio D, Chou T, Coxe S, DeSerisy M, Sanchez AL, Golik A, Martin J, Myers KM, Chase R. Remotely delivering real-time parent training to the home: An initial randomized trial of Internet-delivered parent-child interaction therapy (I-PCIT). J Consult Clin Psychol. 2017 Sep;85(9):909-917. doi: 10.1037/ccp0000230. Epub 2017 Jun 26.
PubMed 28650194Comer JS, Puliafico AC, Aschenbrand SG, McKnight K, Robin JA, Goldfine ME, Albano AM. A pilot feasibility evaluation of the CALM Program for anxiety disorders in early childhood. J Anxiety Disord. 2012 Jan;26(1):40-9. doi: 10.1016/j.janxdis.2011.08.011. Epub 2011 Aug 25.
PubMed 21917417Costello EJ, Mustillo S, Erkanli A, Keeler G, Angold A. Prevalence and development of psychiatric disorders in childhood and adolescence. Arch Gen Psychiatry. 2003 Aug;60(8):837-44. doi: 10.1001/archpsyc.60.8.837.
PubMed 12912767Egger HL, Angold A. Common emotional and behavioral disorders in preschool children: presentation, nosology, and epidemiology. J Child Psychol Psychiatry. 2006 Mar-Apr;47(3-4):313-37. doi: 10.1111/j.1469-7610.2006.01618.x.
PubMed 16492262Guy, W. (1976) ECDEU Assessment Manual for Psychopharmacology - Revised. Rockville, MD: U.S. Department of Health, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, NIMH Psychopharmacology Research Branch, Division of Extramural Research Programs.
Puliafico, A.C., Comer, J.S., & Albano, A.M. (2013). Coaching Approach behavior and Leading by Modeling: Rationale, principles, and a case illustration of the CALM Program for anxious preschoolers. Cognitive and Behavioral Practice, 20, 517-528. doi:http://dx.doi.org/10.1016/j.cbpra.2012.05.002
Puliafico AC, Comer JS, Pincus DB. Adapting parent-child interaction therapy to treat anxiety disorders in young children. Child Adolesc Psychiatr Clin N Am. 2012 Jul;21(3):607-19. doi: 10.1016/j.chc.2012.05.005. Epub 2012 Jun 2.
PubMed 22800997Silverman, W. K., & Albano, A. M. (1997). The Anxiety Disorders Interview Schedule for children for DSM-IV: Child and parent versions. San Antonio, TX: Psychological Corporation.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing Technology to Extend the Reach of Supported Care for Families Affected by Early Child Social Anxiety
- ClinicalTrials.gov ID
- NCT03255122
- Acronym / sponsor ID
- IRB-16-0182
- Conditions
- Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- Andrew Kukes Foundation for Social Anxiety
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Apr 2020 (actual)
- First posted
- 21 Aug 2017 (actual)
- 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.
The goal of the study is to evaluate the efficacy of an Internet-delivered format of an evidence-based CBT treatment for early social anxiety disorder (Coaching Approach behavior and Leading by Modeling, or the CALM Program) in which therapists and families meet in real-time via videoconferencing and parent-child interactions are broadcast from the family's home via a webcam while therapists provide bug-in-the-ear coaching from a remote site. In a randomized controlled trial (RCT), the proposed work will evaluate 40 youth with social anxiety disorder (ages 3-8); 20 will receive the CALM Program over the Internet (I-CALM) and 20 will be assigned to a waitlist control and will complete a course of I-CALM after the waitlist period. Outcomes will be assessed via structured diagnostic interviews and parent-report questionnaires.
Detailed description
The goal of the study is to evaluate the efficacy of an Internet-delivered format of an evidence-based CBT treatment for early child social anxiety disorder (Coaching Approach behavior and Leading by Modeling, or the CALM Program) in which therapists and families meet in real-time via videoconferencing and parent-child interactions are broadcast from the family's home via a webcam while therapists provide bug-in-the-ear coaching from a remote site. In a randomized controlled trial (RCT), the proposed work will evaluate 40 youth with social anxiety disorder (ages 3-8); 20 will receive the CALM Program over the Internet (I-CALM) and 20 will be assigned to a waitlist control, followed by I-CALM treatment.
SPECIFIC AIMS:
- Aim 1: To evaluate I-CALM efficacy for reducing early child social anxiety symptoms and related impairments and for improving child and parent quality of life.
- Aim 2: To examine the extent to which I-CALM helps families overcome traditional barriers to effective care, including geographic barriers and regional professional workforce shortages in social anxiety expert care.
- Aim 3: To evaluate the feasibility, acceptability, and satisfaction of I-CALM from the perspective of treated\ families, and lay the foundation for a large Florida statewide implementation of I-CALM for early social anxiety.
RATIONALE: Despite progress in supported programs for child social anxiety disorder, gaps persist between treatment in specialty clinics and services broadly available in the community. Although considerable advances show social anxiety is treatable when appropriate CBT is available, barriers interfere with the broad provision of quality care. Few sufferers receive services, and those who do receive services do not necessarily receive evidence-based care. Many U.S. counties have no psychologist, psychiatrist, or social worker, let alone professionals trained in supported social anxiety treatments. When effective programs are available, transportation issues constrain access, with large proportions of patients reporting that services are too far away or they have no way to get to a clinic. Expert providers cluster around metropolitan regions and major academic hubs, leaving considerable numbers of youth without access to supported service options. Youth from low-income or remote and rural communities are particularly unlikely to receive appropriate care. High rates of stigma-related beliefs further constrain service utilization, with many reporting negative attitudes about visiting a mental health clinic.
An Internet-delivered, real-time intervention for the remote treatment of early child social anxiety disorder has the potential to meaningfully extend the reach of effective social anxiety treatment for underserved youth and can serve as the critical foundation upon which to build a larger-scale statewide implementation of early social anxiety treatment. Moreover, treating youth in their homes can overcome stigma-related concerns that interfere with families attending services at a psychiatric clinic, and treatment gains may be more generalizable and ecologically valid as services are provided to youth in their natural settings.
SERVICES: The CALM Program (Coaching Approach behavior and Leading by Modeling) was developed as a developmentally compatible intervention to treat anxiety disorders in children below age 8. The CALM Program is an adaptation of Parent-Child Interaction Therapy (PCIT), which was initially developed to treat early behavior problems, and incorporates a family-based approach to early child anxiety. Whereas effective treatment for older socially anxious youth requires a set of cognitive abilities that younger children typically do not fully possess, it has been demonstrated that adaptations of PCIT-which do not target children directly, but rather work to reshape the primary contexts of child development in order to treat child anxiety-can offer more developmentally compatible approaches for intervening with early social anxiety. The CALM Program is a parent-focused treatment that educates families about social anxiety and teaches parents skills to effectively reinforce their children's brave social behavior and coaches the use of these skills during in-session parent-child interactions. The treatment emphasizes live, bug-in-the-ear coaching of parents during in vivo exposure sessions. Child symptoms are targeted by reshaping interaction patterns associated with the maintenance of child anxiety and by reducing parental accommodation of child bids to avoid social situations.
Traditionally, the CALM therapist is situated behind a one-way mirror and unobtrusively provides real-time feedback to parents through a parent-worn earpiece. It has been suggested that PCIT-based approaches are particularly amenable to a web format given that by design the therapist conducts live observation and feedback from another room via a parent-worn bug-in-the-ear device. That is, even in standard clinic-based CALM, the therapist is predominantly separated from the family in order to foster naturalistic family interactions and child behavior. Despite progress in the development of the CALM Program for social anxiety, and progress in the field of behavioral telehealth, research has yet to evaluate the efficacy of an Internet-delivered format of the CALM Program (I-PCIT) for extending the accessibility of treatment. I-CALM families will receive treatment using secure and encrypted videoconferencing software, and parents will receive live coaching via a Bluetooth earpiece. Independent evaluators will conduct diagnostic interviews, collect parent-report forms, and conduct structured observations at baseline, post-treatment, and 6-months follow-up.
OUTCOMES: Independent evaluators (IEs) masked to participant condition assignment will conduct diagnostic interviews, collect parent-report forms, and conduct structured observations at baseline, post-treatment, and 6-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Families are randomly designed to receive either immediate treatment (I-CALM) or waitlist and then I-CALM
| Arm | Type | Receives |
|---|---|---|
| Immediate treatment | Experimental | Behavioral: I-CALMIndividuals in this condition will immediately receive I-CALM treatment, which draws on videoconferencing to remotely deliver real time cognitive-behavioral therapy for early child anxiety to families in their home. |
| Waitlist | Other | Behavioral: Delayed I-CALMIndividuals in Waitlist will participate in an initial waitlist condition, and then after post-waitlist assessment will be offered the I-CALM intervention. Accordingly families in this condition receive Delayed I-CALM. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children 3-8 years old, and at least one primary caregiver
- Child has diagnosis of social anxiety disorder (as assessed in pre-treatment assessment).
- Child and parent both speak either English or Spanish fluently
- Family's home is equipped with computing device and high-speed internet
Key exclusion criteria (4 listed)
- Child has emotional/behavioral problem more impairing than difficulties captured by an anxiety disorder diagnosis.
- Child receiving medication or other psychotherapy to manage emotional difficulties
- History of severe physical or mental impairments (e.g., intellectual disability, deafness, blindness, pervasive developmental disorder) in child or participating caregiver(s)
- Child is a ward of the state
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 |
|---|---|---|
| I-CALMFamilies receiving I-CALM will immediately receive a videoconferencing-based, Internet-delivered format of an evidence-based CBT treatment for early child social anxiety disorder (Coaching Approach behavior and Leading by Modeling, or the CALM Program; Puliafico, Comer, \& Albano, 2013) in which therapists and families meet in real-time via videoconferencing and parent-child interactions are broadcast from the family's home via a webcam while therapists provide bug-in-the-ear coaching from a remote site. Parents are taught and guided in how to coach their young anxious child to engage in brave, approach behavior. | Behavioural | Immediate treatment |
| Delayed I-CALMFamilies receiving Delayed I-CALM will participate in a waitlist period, and then will complete the I-CALM treatment program. | Behavioural | Waitlist |
Primary outcome
Clinical Global Impressions Scales - Severity and Improvement (CGI-S/I)
Time frame: 5 minutes
CGI-S/I is the most widely used clinician-rated measure of treatment-related changes in functioning (Guy \& Bonato, 1970) and will be completed by IEs in the present study. The CGI-S score rates illness severity on a 7-point scale, ranging from 1 ("normal") to 7 ("among the most severely ill patients"). The CGI-I rates clinical improvement on a 7-point scale, ranging from 1 ("very much improved") to 7 ("very much worse").
10 secondary outcomes
Children's Global Assessment Scale
Time frame: 5 minutes
Child Anxiety Impact Scale
Time frame: 5 minutes
Family Burden Assessment Scale
Time frame: 5 minutes
Family Accommodation Checklist and Interference Scale
Time frame: 10 minutes
Family Accommodation Scale- Anxiety
Time frame: 10 minutes
Working Alliance Inventory
Time frame: 10 minutes
Client Satisfaction Questionnaire
Time frame: 3 minutes
Child Behavior Checklist
Time frame: 25 minutes
Anxiety Disorders Interview Schedule for Children (ADIS-C/P)
Time frame: 2 hours
Spence Children's Anxiety Scale
Time frame: 15 minutes
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 2 Jul 2020.
- Background: PubMed 25212716Carpenter AL, Puliafico AC, Kurtz SM, Pincus DB, Comer JS. Extending parent-child interaction therapy for early childhood internalizing problems: new advances for an overlooked population. Clin Child Fam Psychol Rev. 2014 Dec;17(4):340-56. doi: 10.1007/s10567-014-0172-4.
- BackgroundComer, J.S. (2015). Introduction to the special section: Applying new technologies to extend the scope and accessibility of mental health care. Cognitive and Behavioral Practice, 22, 253-257. doi:http://dx.doi.org/10.1016/j.cbpra.2015.04.002
- Background: PubMed 23915401Comer JS, Barlow DH. The occasional case against broad dissemination and implementation: retaining a role for specialty care in the delivery of psychological treatments. Am Psychol. 2014 Jan;69(1):1-18. doi: 10.1037/a0033582. Epub 2013 Aug 5.
- Background: PubMed 20816036Comer JS, Blanco C, Hasin DS, Liu SM, Grant BF, Turner JB, Olfson M. Health-related quality of life across the anxiety disorders: results from the national epidemiologic survey on alcohol and related conditions (NESARC). J Clin Psychiatry. 2011 Jan;72(1):43-50. doi: 10.4088/JCP.09m05094blu. Epub 2010 Aug 24.
- Background: PubMed 24295036Comer JS, Furr JM, Cooper-Vince CE, Kerns CE, Chan PT, Edson AL, Khanna M, Franklin ME, Garcia AM, Freeman JB. Internet-delivered, family-based treatment for early-onset OCD: a preliminary case series. J Clin Child Adolesc Psychol. 2014;43(1):74-87. doi: 10.1080/15374416.2013.855127. Epub 2013 Dec 2.
- Background: PubMed 26120268Comer JS, Furr JM, Cooper-Vince C, Madigan RJ, Chow C, Chan P, Idrobo F, Chase RM, McNeil CB, Eyberg SM. Rationale and Considerations for the Internet-Based Delivery of Parent-Child Interaction Therapy. Cogn Behav Pract. 2015 Aug 1;22(3):302-316. doi: 10.1016/j.cbpra.2014.07.003.
- Background: PubMed 27869451Comer JS, Furr JM, Kerns CE, Miguel E, Coxe S, Elkins RM, Carpenter AL, Cornacchio D, Cooper-Vince CE, DeSerisy M, Chou T, Sanchez AL, Khanna M, Franklin ME, Garcia AM, Freeman JB. Internet-delivered, family-based treatment for early-onset OCD: A pilot randomized trial. J Consult Clin Psychol. 2017 Feb;85(2):178-186. doi: 10.1037/ccp0000155. Epub 2016 Nov 21.
- Background: PubMed 28650194Comer JS, Furr JM, Miguel EM, Cooper-Vince CE, Carpenter AL, Elkins RM, Kerns CE, Cornacchio D, Chou T, Coxe S, DeSerisy M, Sanchez AL, Golik A, Martin J, Myers KM, Chase R. Remotely delivering real-time parent training to the home: An initial randomized trial of Internet-delivered parent-child interaction therapy (I-PCIT). J Consult Clin Psychol. 2017 Sep;85(9):909-917. doi: 10.1037/ccp0000230. Epub 2017 Jun 26.
- Background: PubMed 21917417Comer JS, Puliafico AC, Aschenbrand SG, McKnight K, Robin JA, Goldfine ME, Albano AM. A pilot feasibility evaluation of the CALM Program for anxiety disorders in early childhood. J Anxiety Disord. 2012 Jan;26(1):40-9. doi: 10.1016/j.janxdis.2011.08.011. Epub 2011 Aug 25.
- Background: PubMed 12912767Costello EJ, Mustillo S, Erkanli A, Keeler G, Angold A. Prevalence and development of psychiatric disorders in childhood and adolescence. Arch Gen Psychiatry. 2003 Aug;60(8):837-44. doi: 10.1001/archpsyc.60.8.837.
- Background: PubMed 16492262Egger HL, Angold A. Common emotional and behavioral disorders in preschool children: presentation, nosology, and epidemiology. J Child Psychol Psychiatry. 2006 Mar-Apr;47(3-4):313-37. doi: 10.1111/j.1469-7610.2006.01618.x.
- BackgroundGuy, W. (1976) ECDEU Assessment Manual for Psychopharmacology - Revised. Rockville, MD: U.S. Department of Health, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, NIMH Psychopharmacology Research Branch, Division of Extramural Research Programs.
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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.
Jonathan S Comer, PhD principal investigator
Florida International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-CALM and Delayed I-CALM in people with Anxiety Disorders, run by Florida International University 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 4 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: finished, as of the sponsor's last update on 2 Jul 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?
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?
Clinical Global Impressions Scales - Severity and Improvement (CGI-S/I) (time frame: 5 minutes). 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 NCT03255122, which also lists 23 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 2 Jul 2020.