Behavioral InhibitionNCT02308826
Multi-Component Early Intervention for Socially Inhibited Preschool Children
A study testing Turtle Program and Cool Little Kids in people with Behavioral Inhibition and Anxiety, run by University of Maryland, College Park at 1 site in United States.
Trial summary
This project is intended to provide a rigorous test of the Turtle Program, an early intervention program for behaviorally inhibited preschoolers. The proposed project will extend promising pilot study findings by: (a) evaluating the integrated intervention in a larger sample (n = 150) of 45-64 month children and their… Read more about this study
- Who is it for?
- Ages 45 to 64 months
- Conditions the study is for
- Behavioral Inhibition, Anxiety
- What is being tested?
- Turtle Program and Cool Little Kids
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Jun 2019
- 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 45 to 64 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child must be attending preschool; child must score within top 15% on parent-rated Behavioral Inhibition Questionnaire
Who cannot join
- child has a diagnosis of pervasive developmental disorder, selective mutism, or mental retardation; child scores above clinical cutoff on Social Communication Questionnaire; child is currently receiving treatment for anxiety; child does not have a custodial parent who has also consented to participate
Trial locations and contacts
1 site in 1 country.
About this study
This project is intended to provide a rigorous test of the Turtle Program, an early intervention program for behaviorally inhibited preschoolers. The proposed project will extend promising pilot study findings by: (a) evaluating the integrated intervention in a larger sample (n = 150) of 45-64 month children and their parents, which will allow for an examination of mediators and moderators of treatment effects; (b) comparing the Turtle Program to the best available treatment for preschool behavioral inhibition, the Cool Little Kids (CLK) parent psychoeducation group; (c) examining heart rate reactivity and regulation as both baseline moderators of treatment response and as outcome measures; (d) examining parent anxiety disorders as a moderator of treatment response; (e) including a mid-treatment assessment and extending follow-up to one year.
- Conditions
- Behavioral Inhibition, Anxiety
- Being tested
- Turtle Program, Cool Little Kids
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turtle ProgramBehavioural
Cool Little KidsBehavioural
| 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 |
| Cool Little Kids | Active comparator | A 6-week parent psychoeducation group administered over an 8-week period. Receives: Behavioral: Cool Little Kids |
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 (Anxiety Disorders Interview Schedule) with parents
Measured: pre-treatment, mid-treatment (week 4), post-treatment (week 8), and 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 169 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
- NCT02308826
- Sponsor's protocol ID
- R01MH103253-01A1
- Status last verified
- May 2023
- First submitted
- 2 Dec 2014
- Last updated
- 10 May 2023
- Results posted
- No
Publications
Fleece H, Wagner NJ, Chronis-Tuscano A, Smith KA, Novick DR, Druskin LR, Shakiba N, Danko CM, Rubin KH. Can behaviorally inhibited preschoolers make friends? Dev Psychol. 2024 Jul;60(7):1203-1213. doi: 10.1037/dev0001742. Epub 2024 Apr 22.
PubMed 38647467Novick DR, Meyer CT, Wagner NJ, Rubin KH, Danko CM, Dougherty LR, Druskin LR, Smith KA, Chronis-Tuscano A. Testing reciprocal associations between child anxiety and parenting across early interventions for inhibited preschoolers. J Child Psychol Psychiatry. 2023 Dec;64(12):1665-1678. doi: 10.1111/jcpp.13879. Epub 2023 Aug 29.
PubMed 37644651Wagner NJ, Shakiba N, Bui HNT, Sem K, Novick DR, Danko CM, Dougherty LR, Chronis-Tuscano A, Rubin KH. Examining the Relations Between Children's Vagal Flexibility Across Social Stressor Tasks and Parent- and Clinician-Rated Anxiety Using Baseline Data from an Early Intervention for Inhibited Preschoolers. Res Child Adolesc Psychopathol. 2023 Aug;51(8):1213-1224. doi: 10.1007/s10802-023-01050-3. Epub 2023 Mar 24.
PubMed 36961596Chronis-Tuscano A, Novick DR, Danko CM, Smith KA, Wagner NJ, Wang CH, Druskin L, Dougherty LR, Rubin KH. Early intervention for inhibited young children: a randomized controlled trial comparing the Turtle Program and Cool Little Kids. J Child Psychol Psychiatry. 2022 Mar;63(3):273-281. doi: 10.1111/jcpp.13475. Epub 2021 Jun 29.
PubMed 34184792
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
- Multi-Component Early Intervention for Socially Inhibited Preschool Children
- ClinicalTrials.gov ID
- NCT02308826
- Acronym / sponsor ID
- R01MH103253-01A1
- Conditions
- Behavioral Inhibition, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 4 Dec 2014 (estimated)
- 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 is intended to provide a rigorous test of the Turtle Program, an early intervention program for behaviorally inhibited preschoolers. The proposed project will extend promising pilot study findings by: (a) evaluating the integrated intervention in a larger sample (n = 150) of 45-64 month children and their parents, which will allow for an examination of mediators and moderators of treatment effects; (b) comparing the Turtle Program to the best available treatment for preschool behavioral inhibition, the Cool Little Kids (CLK) parent psychoeducation group; (c) examining heart rate reactivity and regulation as both baseline moderators of treatment response and as outcome measures; (d) examining parent anxiety disorders as a moderator of treatment response; (e) including a mid-treatment assessment and extending follow-up to one year.
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. |
| Cool Little Kids | Active comparator | Behavioral: Cool Little KidsA 6-week parent psychoeducation group administered over an 8-week period. |
Who may qualify
- Ages
- 45 to 64 months
- Sex
- All
- Healthy volunteers
- Not 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
Key exclusion criteria (1 listed)
- child has a diagnosis of pervasive developmental disorder, selective mutism, or mental retardation; child scores above clinical cutoff on Social Communication Questionnaire; child is currently receiving treatment for anxiety; child does not have a custodial parent who has also consented to participate
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 |
|---|---|---|
| Turtle Program | Behavioural | Turtle Program |
| Cool Little Kids | Behavioural | Cool Little Kids |
Primary outcome
Change in child anxiety disorder symptoms
Time frame: pre-treatment, mid-treatment (week 4), post-treatment (week 8), and 1-year follow-up
Assessed with diagnostic interviews (Anxiety Disorders Interview Schedule) 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.
- Derived from this study: PubMed 38647467Fleece H, Wagner NJ, Chronis-Tuscano A, Smith KA, Novick DR, Druskin LR, Shakiba N, Danko CM, Rubin KH. Can behaviorally inhibited preschoolers make friends? Dev Psychol. 2024 Jul;60(7):1203-1213. doi: 10.1037/dev0001742. Epub 2024 Apr 22.
- Derived from this study: PubMed 37644651Novick DR, Meyer CT, Wagner NJ, Rubin KH, Danko CM, Dougherty LR, Druskin LR, Smith KA, Chronis-Tuscano A. Testing reciprocal associations between child anxiety and parenting across early interventions for inhibited preschoolers. J Child Psychol Psychiatry. 2023 Dec;64(12):1665-1678. doi: 10.1111/jcpp.13879. Epub 2023 Aug 29.
- Derived from this study: PubMed 36961596Wagner NJ, Shakiba N, Bui HNT, Sem K, Novick DR, Danko CM, Dougherty LR, Chronis-Tuscano A, Rubin KH. Examining the Relations Between Children's Vagal Flexibility Across Social Stressor Tasks and Parent- and Clinician-Rated Anxiety Using Baseline Data from an Early Intervention for Inhibited Preschoolers. Res Child Adolesc Psychopathol. 2023 Aug;51(8):1213-1224. doi: 10.1007/s10802-023-01050-3. Epub 2023 Mar 24.
- Derived from this study: PubMed 34184792Chronis-Tuscano A, Novick DR, Danko CM, Smith KA, Wagner NJ, Wang CH, Druskin L, Dougherty LR, Rubin KH. Early intervention for inhibited young children: a randomized controlled trial comparing the Turtle Program and Cool Little Kids. J Child Psychol Psychiatry. 2022 Mar;63(3):273-281. doi: 10.1111/jcpp.13475. Epub 2021 Jun 29.
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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 Turtle Program and Cool Little Kids 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, mid-treatment (week 4), post-treatment (week 8), and 1-year follow-up). 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 NCT02308826, which also lists 4 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 10 May 2023.