Growth & DevelopmentNCT03431545
An Integrative Approach to Improve Child Outcomes Through Research-based Parent and Teacher Interventions
A study testing PALS and and BEECH in people with Growth & Development, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to learn whether a combination of two research-proven programs, a responsive caregiving parenting program and a teacher training program, will have an effect on infants' and toddlers' language, cognitive, social-emotional, and self-regulation skills. Read more about this study
- Who is it for?
- Ages 5 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Growth & Development
- What is being tested?
- PALS and and BEECH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 19 Sep 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 5 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Given that the target population includes EHS agencies, low-income children speaking English and/or Spanish will be eligible for participation.
- In some cases, children with mild delays (e.g., receiving speech therapy services) can participate.
Who cannot join
- Children with significant developmental disabilities (e.g., intellectual disabilities, significant sensory impairments, and children diagnosed with moderately severe forms of Autism Spectrum Disorders) will not be consented for assessments as the interventions are not specialized to meet the needs of these children.
- Children primarily speaking a language other than Spanish or English will be excluded due to the fact that appropriate assessment procedures are lacking.
- In terms of exclusionary criteria for teachers, those that are participating in other research studies, or who have recently completed other similar studies, will not be recruited.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to learn whether a combination of two research-proven programs, a responsive caregiving parenting program and a teacher training program, will have an effect on infants' and toddlers' language, cognitive, social-emotional, and self-regulation skills. The interventions are designed to specifically target parent use of a responsive, stimulating caregiving style in the home in combination with teacher instructional practices and the use of a responsive interactive style in the classroom.
- Conditions
- Growth & Development
- Being tested
- PALS and, BEECH, Control condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PALS andBehavioural
Play and Learning Strategies (PALS) include web-based parent training courses with remote coaching and in-person meetings that support the adults' developing a set of core behaviors that comprise a responsive interactive style including responses contingent to children's needs and interests with rich language input.
Parents will begin their 11 week (infant) or 14 week (toddler) parenting program in October and complete it by April. There will be monthly Parent Meetings related to the content they are learning online. Post-assessments will occur in late April and May. Each weekly online parent session will take approximately 30 minutes to complete with a 40 - 60 minute weekly remote coach call.
BEECHBehavioural
Beginning Education: Early Childcare at Home (BEECH) includes web-based teacher training courses with remote coaching and in-person meetings that support the adults' developing a set of core behaviors that comprise a responsive interactive style including responses contingent to children's needs and interests with rich language input.
Teachers will complete the 20 online sessions weekly, except for planned center closings due to holidays or agency-related events. The three in-person trainings will occur before Session 1 and after Sessions 8 and 14. Each weekly online teacher session will take approximately one-hour for a teacher to complete with a 30 minute weekly remote coach call. Each in-person teacher training will be 6-hours in duration.
Control conditionBehavioural
Parents and teachers conduct business as usual in regards to care-giving in the school and at home.
| Study group | Role | What they receive |
|---|---|---|
| PALS and BEECH | Experimental | Play and Learning Strategies (PALS) and Beginning Education: Early Childcare at Home (BEECH) include web-based parent and teacher training courses with remote coaching and in-person meetings that support the adults' developing a set of core behaviors that comprise a responsive interactive style including responses contingent to children's needs and interests with rich language input. Receives: Behavioral: PALS and; Behavioral: BEECH |
| Control condition | Active comparator | Parents and teachers conduct business as usual in regards to care-giving in the school and at home. Receives: Behavioral: Control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in teacher behavior as assessed by the The Quality of Caregiver-Child Interactions for Infant and Toddlers (Q-CCIIT) Scale
Scales: Support for Social Emotional Development (ratings range from 1 to 7 with higher values indicate better outcome), Support for Language and Literacy (ratings range from 1 to 7 with higher values indicate better outcome), Support for Cognitive Development (ratings range from 1 to 7 with higher values indicate better outcome), Areas of Concern (ratings range from 1 to 3 with higher values indicate worse outcome)
Measured: baseline, 9 months
Change in parent behavior as assessed by coding of videotaped parent-child interactions during toy play in the home
The parent-child dyad will be provided with a set of age-appropriate toys to use during a 15 minute period where parents are asked to play with their children in "typical ways" with a few constraints (e.g., television must be off). Specific variables in each of the four responsiveness components (i.e., support of children's signals and interests, contingent responsiveness, rich language input, warm sensitivity) will be coded from the activity using a previously developed coding system for videotaped parent-child interactions.
Measured: baseline, 9 months
Change in parent behavior as assessed by coding of videotaped parent-child interactions during shared reading in the home
Parent and child will be asked to engage in a 5 minute shared reading activity using books provided to family. Specific variables in each of the four responsiveness components (i.e., support of children's signals and interests, contingent responsiveness, rich language input, warm sensitivity) will be coded from the activity using a previously developed coding system for videotaped parent-child interactions.
Measured: baseline, 9 months
Change in child language as assessed by the Preschool Language Scale-Fifth Edition
Auditory Comprehension Scale (standard scores range from 50 - 150 with higher value representing a better outcome)
Measured: baseline, 9 months
Change in child language as assessed by the Early Communication Indicator
Measured: baseline, 9 months
Change in child language as assessed by the MacArthur-Bates Communicative Development Inventories - Short Form (parent reported)
Measured: baseline, 9 months
Change in child cognitive skills as assessed by the Bayley Scales of Development - III Screening Test
Cognitive Scale (cut score based on child's chronological age places child in either 'at-risk,' 'emerging,' and 'competent' category)
Measured: baseline, 9 months
Change in child social-emotional behaviors as assessed by coding of videotaped parent-child interactions during toy play in the home.
Children's social behaviors in the home will be coded for: 1) cooperation, 2) language use, 3) social engagement, and 4) initiative during parent-child home-based "free play" interaction.
Measured: baseline, 9 months
Change in child social-emotional behaviors as assessed by coding of videotaped parent-child interactions during c in the home.
Children's social behaviors in the home will be coded for: 1) cooperation, 2) language use, 3) social engagement, and 4) initiative during parent-child home-based "shared reading" interaction.
Measured: baseline, 9 months
Change in child socio-emotional skills as assessed by the Brief Infant Toddler Social Emotional Assessment (parent reported)
Measured: baseline, 9 months
Change in child self-regulation as assessed by a delay task
A delay task will be administered to children 24 months and older. In the "Gift/Waiting for the Bow" paradigm the child is left alone for 3 minutes with the gift while the examiner gets a bow (actually, the experimenter will turn his/her back and engage in other activities) and is told not to touch or open the gift; latencies to touching and opening are recorded.
Measured: baseline, 9 months
Change in child self-regulation as assessed by a slowing down motor task
A slowing down motor task will be administered to children 18 months and older. In the "Walk the Line" task, the child walks as slowly as possible down a 6 foot tape line on the floor to their parent; times for a baseline trial (child walk to parent as they normally would) and two slow trials are recorded live. This measure taps early inhibitory control, particularly the ability to modulate a response to context.
Measured: baseline, 9 months
Change in child self-regulation as assessed by a suppressing/initiating a response task
A suppressing/initiating a response task will be administered to children 22 months and older. In the "Tower" task the child and the experimenter build a tower together out of big, foam blocks. The experimenter explains to the child what it means to "take turns." The experimenter then deliberately waits for the child to indicate that the experimenter may have a turn. This task also taps early inhibitory control, particularly the ability to inhibit a desired response (to place the block oneself), in favor of a more socially desirable response (give the experimenter a turn).
Measured: baseline, 9 months
Secondary outcomes (5)
Change in teacher characteristics as assessed by the Center for Epidemiologic Studies Depression Scale - Revised
One depression scale (range from 0 - 4 with higher values related to worse outcomes)
Measured: baseline, 9 months
Change in teacher characteristics as assessed by the Parental Modernity Scale
Two subscales: traditional beliefs (ratings from 1 - 5 with higher values representing traditional beliefs) and progressive beliefs (ratings from 1 - 5 with higher values representing progressive beliefs).
Measured: baseline, 9 months
Change in parent characteristics as assessed by the Center for Epidemiologic Studies Depression Scale - Revised
One depression scale (range from 0 - 4 with higher values related to worse outcomes)
Measured: baseline, 9 months
Change in parent characteristics as assessed by the Parental Modernity Scale
Two subscales: traditional beliefs (ratings from 1 - 5 with higher values representing traditional beliefs) and progressive beliefs (ratings from 1 - 5 with higher values representing progressive beliefs).
Measured: baseline, 9 months
Change in parent characteristics as assessed by the Parenting Stress Index, Fourth Edition Short Form
Measured: baseline, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Aug 2016
- Primary completion19 Sep 2019
- Study completion19 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth & DevelopmentStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Landry, The University of Texas Health Science Center, Houston
- Investigators
- Janelle J Montroy, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431545
- Sponsor's protocol ID
- HSC-MS-15-0841
- Status last verified
- May 2022
- First submitted
- 6 Feb 2018
- Last updated
- 9 May 2022
- 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 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrative Approach to Improve Child Outcomes Through Research-based Parent and Teacher Interventions
- ClinicalTrials.gov ID
- NCT03431545
- Acronym / sponsor ID
- HSC-MS-15-0841
- Conditions
- Growth & Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 19 Sep 2019 (actual)
- Study completion
- 19 Sep 2019 (actual)
- First posted
- 13 Feb 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.
The purpose of this study is to learn whether a combination of two research-proven programs, a responsive caregiving parenting program and a teacher training program, will have an effect on infants' and toddlers' language, cognitive, social-emotional, and self-regulation skills. The interventions are designed to specifically target parent use of a responsive, stimulating caregiving style in the home in combination with teacher instructional practices and the use of a responsive interactive style in the classroom.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PALS and BEECH | Experimental | Behavioral: PALS and, Behavioral: BEECHPlay and Learning Strategies (PALS) and Beginning Education: Early Childcare at Home (BEECH) include web-based parent and teacher training courses with remote coaching and in-person meetings that support the adults' developing a set of core behaviors that comprise a responsive interactive style including responses contingent to children's needs and interests with rich language input. |
| Control condition | Active comparator | Behavioral: Control conditionParents and teachers conduct business as usual in regards to care-giving in the school and at home. |
Who may qualify
- Ages
- 5 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Given that the target population includes EHS agencies, low-income children speaking English and/or Spanish will be eligible for participation.
- In some cases, children with mild delays (e.g., receiving speech therapy services) can participate.
Key exclusion criteria (3 listed)
- Children with significant developmental disabilities (e.g., intellectual disabilities, significant sensory impairments, and children diagnosed with moderately severe forms of Autism Spectrum Disorders) will not be consented for assessments as the interventions are not specialized to meet the needs of these children.
- Children primarily speaking a language other than Spanish or English will be excluded due to the fact that appropriate assessment procedures are lacking.
- In terms of exclusionary criteria for teachers, those that are participating in other research studies, or who have recently completed other similar studies, will not be recruited.
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 |
|---|---|---|
| PALS andPlay and Learning Strategies (PALS) include web-based parent training courses with remote coaching and in-person meetings that support the adults' developing a set of core behaviors that comprise a responsive interactive style including responses contingent to children's needs and interests with rich language input. Parents will begin their 11 week (infant) or 14 week (toddler) parenting program in October and complete it by April. There will be monthly Parent Meetings related to the content they are learning online. Post-assessments will occur in late April and May. Each weekly online parent session will take approximately 30 minutes to complete with a 40 - 60 minute weekly remote coach call. | Behavioural | PALS and BEECH |
| BEECHBeginning Education: Early Childcare at Home (BEECH) includes web-based teacher training courses with remote coaching and in-person meetings that support the adults' developing a set of core behaviors that comprise a responsive interactive style including responses contingent to children's needs and interests with rich language input. Teachers will complete the 20 online sessions weekly, except for planned center closings due to holidays or agency-related events. The three in-person trainings will occur before Session 1 and after Sessions 8 and 14. Each weekly online teacher session will take approximately one-hour for a teacher to complete with a 30 minute weekly remote coach call. Each in-person teacher training will be 6-hours in duration. | Behavioural | PALS and BEECH |
| Control conditionParents and teachers conduct business as usual in regards to care-giving in the school and at home. | Behavioural | Control condition |
Primary outcome
Change in teacher behavior as assessed by the The Quality of Caregiver-Child Interactions for Infant and Toddlers (Q-CCIIT) Scale
Time frame: baseline, 9 months
Scales: Support for Social Emotional Development (ratings range from 1 to 7 with higher values indicate better outcome), Support for Language and Literacy (ratings range from 1 to 7 with higher values indicate better outcome), Support for Cognitive Development (ratings range from 1 to 7 with higher values indicate better outcome), Areas of Concern (ratings range from 1 to 3 with higher values indicate worse outcome)
Change in parent behavior as assessed by coding of videotaped parent-child interactions during toy play in the home
Time frame: baseline, 9 months
The parent-child dyad will be provided with a set of age-appropriate toys to use during a 15 minute period where parents are asked to play with their children in "typical ways" with a few constraints (e.g., television must be off). Specific variables in each of the four responsiveness components (i.e., support of children's signals and interests, contingent responsiveness, rich language input, warm sensitivity) will be coded from the activity using a previously developed coding system for videotaped parent-child interactions.
Change in parent behavior as assessed by coding of videotaped parent-child interactions during shared reading in the home
Time frame: baseline, 9 months
Parent and child will be asked to engage in a 5 minute shared reading activity using books provided to family. Specific variables in each of the four responsiveness components (i.e., support of children's signals and interests, contingent responsiveness, rich language input, warm sensitivity) will be coded from the activity using a previously developed coding system for videotaped parent-child interactions.
Change in child language as assessed by the Preschool Language Scale-Fifth Edition
Time frame: baseline, 9 months
Auditory Comprehension Scale (standard scores range from 50 - 150 with higher value representing a better outcome)
Change in child language as assessed by the Early Communication Indicator
Time frame: baseline, 9 months
Change in child language as assessed by the MacArthur-Bates Communicative Development Inventories - Short Form (parent reported)
Time frame: baseline, 9 months
Change in child cognitive skills as assessed by the Bayley Scales of Development - III Screening Test
Time frame: baseline, 9 months
Cognitive Scale (cut score based on child's chronological age places child in either 'at-risk,' 'emerging,' and 'competent' category)
Change in child social-emotional behaviors as assessed by coding of videotaped parent-child interactions during toy play in the home.
Time frame: baseline, 9 months
Children's social behaviors in the home will be coded for: 1) cooperation, 2) language use, 3) social engagement, and 4) initiative during parent-child home-based "free play" interaction.
Change in child social-emotional behaviors as assessed by coding of videotaped parent-child interactions during c in the home.
Time frame: baseline, 9 months
Children's social behaviors in the home will be coded for: 1) cooperation, 2) language use, 3) social engagement, and 4) initiative during parent-child home-based "shared reading" interaction.
Change in child socio-emotional skills as assessed by the Brief Infant Toddler Social Emotional Assessment (parent reported)
Time frame: baseline, 9 months
Change in child self-regulation as assessed by a delay task
Time frame: baseline, 9 months
A delay task will be administered to children 24 months and older. In the "Gift/Waiting for the Bow" paradigm the child is left alone for 3 minutes with the gift while the examiner gets a bow (actually, the experimenter will turn his/her back and engage in other activities) and is told not to touch or open the gift; latencies to touching and opening are recorded.
Change in child self-regulation as assessed by a slowing down motor task
Time frame: baseline, 9 months
A slowing down motor task will be administered to children 18 months and older. In the "Walk the Line" task, the child walks as slowly as possible down a 6 foot tape line on the floor to their parent; times for a baseline trial (child walk to parent as they normally would) and two slow trials are recorded live. This measure taps early inhibitory control, particularly the ability to modulate a response to context.
Change in child self-regulation as assessed by a suppressing/initiating a response task
Time frame: baseline, 9 months
A suppressing/initiating a response task will be administered to children 22 months and older. In the "Tower" task the child and the experimenter build a tower together out of big, foam blocks. The experimenter explains to the child what it means to "take turns." The experimenter then deliberately waits for the child to indicate that the experimenter may have a turn. This task also taps early inhibitory control, particularly the ability to inhibit a desired response (to place the block oneself), in favor of a more socially desirable response (give the experimenter a turn).
5 secondary outcomes
Change in teacher characteristics as assessed by the Center for Epidemiologic Studies Depression Scale - Revised
Time frame: baseline, 9 months
Change in teacher characteristics as assessed by the Parental Modernity Scale
Time frame: baseline, 9 months
Change in parent characteristics as assessed by the Center for Epidemiologic Studies Depression Scale - Revised
Time frame: baseline, 9 months
Change in parent characteristics as assessed by the Parental Modernity Scale
Time frame: baseline, 9 months
Change in parent characteristics as assessed by the Parenting Stress Index, Fourth Edition Short Form
Time frame: baseline, 9 months
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 9 May 2022.
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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.
Janelle J Montroy, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PALS and and BEECH in people with Growth & Development, run by The University of Texas Health Science Center, Houston 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 2 inclusion and 3 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 9 May 2022. 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 teacher behavior as assessed by the The Quality of Caregiver-Child Interactions for Infant and Toddlers (Q-CCIIT) Scale (time frame: baseline, 9 months). The study lists 13 primary outcomes in all. 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 9 May 2022.