Behavioral InhibitionNCT03486860
A Multi-Method Early Intervention Program for Inhibited and Anxious Preschoolers
A study testing Parent Psychoeducation and Turtle Program in people with Behavioral Inhibition and Anxiety, run by University of Maryland, College Park at 1 site in United States.
Trial summary
This project aims to develop and evaluate a novel early intervention program that targets the specific risk factors implicated in the development and persistence of shyness, social reticence, and withdrawal in children. Read more about this study
- Who is it for?
- Ages 42 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Behavioral Inhibition, Anxiety
- What is being tested?
- Parent Psychoeducation and Turtle Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2010to 30 Nov 2012
- 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 42 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child must be attending preschool; child must score within top 15% on parent-rated Behavioral Inhibition Questionnaire; child has a biological parent with at least 50% physical custody who consents to participate
Who cannot join
- Child has a diagnosis of pervasive developmental disorder or mental retardation; child scores above clinical cutoff on Social Communication Questionnaire; child is currently receiving treatment for anxiety
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland
College Park, Maryland, 20742
About this study
This project aims to develop and evaluate a novel early intervention program that targets the specific risk factors implicated in the development and persistence of shyness, social reticence, and withdrawal in children. The project includes a program development phase, Phase I (pilot test of full study procedures using developed treatment protocol), and Phase II (randomized controlled trial/RCT). Outcomes that will be assessed include change in child behavioral inhibition and parenting, using parent and teacher reports and observational data. Families are assessed at three time points: baseline, post-treatment (or at approximately 8 weeks for the control group), and 2 month follow-up.
- Conditions
- Behavioral Inhibition, Anxiety
- Being tested
- Parent Psychoeducation, Turtle Program
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent PsychoeducationBehavioural
6-session parent psychoeducation group on child anxiety, following their children's lead, and encouraging approach behaviors.
Turtle ProgramBehavioural
The Turtle Program involves a child social and emotional skills group (Social Skills Facilitated Play) and a modification of Parent-Child Interaction Therapy in which parents are provided in-vivo coaching in following their children's lead and encouraging approach behaviors within the peer context. The child group provides a forum of same-age peers to learn to develop social and emotion regulation skills. The Turtle Program is administered over an 8-week period.
| Study group | Role | What they receive |
|---|---|---|
| Turtle Program | Experimental | The Turtle Program involves a child social and emotional skills group (Social Skills Facilitated Play) and a modification of Parent-Child Interaction Therapy in which parents are provided in-vivo coaching in following their children's lead and encouraging approach behaviors within the peer context. The child group provides a forum of same-age peers to learn to develop social and emotion regulation skills. The Turtle Program is administered over an 8-week period. Receives: Behavioral: Turtle Program |
| Waitlist Control | Other | Untreated comparison group during the study, received parent psychoeducation intervention after the active treatment group. Receives: Behavioral: Parent Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in child anxiety disorder symptoms
Assessed with diagnostic interviews (Preschool Age Psychiatric Assessment) with parents
Measured: Pre-treatment (baseline), post-treatment (week 8), and 2-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start1 Feb 2010
- Primary completion30 Nov 2012
- Study completion30 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral InhibitionStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Chronis-Tuscano, University of Maryland, College Park
- Investigators
- Andrea Chronis-Tuscano, Ph.D., Principal investigator, University of MarylandKenneth Rubin, Ph.D., Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486860
- Sponsor's protocol ID
- R34MH083832
- Status last verified
- May 2023
- First submitted
- 27 Mar 2018
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Method Early Intervention Program for Inhibited and Anxious Preschoolers
- ClinicalTrials.gov ID
- NCT03486860
- Acronym / sponsor ID
- R34MH083832
- Conditions
- Behavioral Inhibition, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Study start
- 1 Feb 2010 (actual)
- Primary completion
- 30 Nov 2012 (actual)
- Study completion
- 30 Nov 2012 (actual)
- First posted
- 3 Apr 2018 (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.
This project aims to develop and evaluate a novel early intervention program that targets the specific risk factors implicated in the development and persistence of shyness, social reticence, and withdrawal in children. The project includes a program development phase, Phase I (pilot test of full study procedures using developed treatment protocol), and Phase II (randomized controlled trial/RCT). Outcomes that will be assessed include change in child behavioral inhibition and parenting, using parent and teacher reports and observational data. Families are assessed at three time points: baseline, post-treatment (or at approximately 8 weeks for the control group), and 2 month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Turtle Program | Experimental | Behavioral: Turtle ProgramThe Turtle Program involves a child social and emotional skills group (Social Skills Facilitated Play) and a modification of Parent-Child Interaction Therapy in which parents are provided in-vivo coaching in following their children's lead and encouraging approach behaviors within the peer context. The child group provides a forum of same-age peers to learn to develop social and emotion regulation skills. The Turtle Program is administered over an 8-week period. |
| Waitlist Control | Other | Behavioral: Parent PsychoeducationUntreated comparison group during the study, received parent psychoeducation intervention after the active treatment group. |
Who may qualify
- Ages
- 42 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child must be attending preschool; child must score within top 15% on parent-rated Behavioral Inhibition Questionnaire; child has a biological parent with at least 50% physical custody who consents to participate
Key exclusion criteria (1 listed)
- Child has a diagnosis of pervasive developmental disorder or mental retardation; child scores above clinical cutoff on Social Communication Questionnaire; child is currently receiving treatment for anxiety
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 |
|---|---|---|
| Parent Psychoeducation6-session parent psychoeducation group on child anxiety, following their children's lead, and encouraging approach behaviors. | Behavioural | Waitlist Control |
| Turtle ProgramThe Turtle Program involves a child social and emotional skills group (Social Skills Facilitated Play) and a modification of Parent-Child Interaction Therapy in which parents are provided in-vivo coaching in following their children's lead and encouraging approach behaviors within the peer context. The child group provides a forum of same-age peers to learn to develop social and emotion regulation skills. The Turtle Program is administered over an 8-week period. | Behavioural | Turtle Program |
Primary outcome
Change in child anxiety disorder symptoms
Time frame: Pre-treatment (baseline), post-treatment (week 8), and 2-month follow-up
Assessed with diagnostic interviews (Preschool Age Psychiatric Assessment) with parents
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 10 May 2023.
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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.
Andrea Chronis-Tuscano, Ph.D. principal investigator
University of Maryland
Kenneth Rubin, Ph.D. principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Psychoeducation and Turtle Program in people with Behavioral Inhibition and Anxiety, run by University of Maryland, College Park 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 1 inclusion and 1 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 10 May 2023. 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?
Change in child anxiety disorder symptoms (time frame: Pre-treatment (baseline), post-treatment (week 8), and 2-month follow-up). 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 10 May 2023.