ParentingNCT03704974
The Impact of Parent Training on the Child's Health Services
An observational study of Parenting and Child Rearing, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
The purpose of the study is to determine whether parent training with the Incredible Years Parent Program delivered in pediatric primary care decreases usage of healthcare services for the next year when compared to annual healthcare service use during the two years prior to the parents participating in program. Read more about this study
- Who is it for?
- Ages 36 to 83 months
- Conditions the study is for
- Parenting, Child Rearing, Child Behavior Problem
- What is being tested?
- Video-Based Parent Training Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2018to 22 Jun 2022
- Phase
- Observational
- 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 36 to 83 months
- All sexes
- No healthy volunteers
- Child
Study population: Children participating in the study will be referred from the AltaMed Federally Qualified Health Center, which manages the primary pediatric care at Children's Hospital Los Angeles for 20,000 children who generate 85,000 outpatient visits per year. The population reflects the diversity of Los Angeles County and is predominantly Latino.
Who may be able to join
- Children receiving primary care at CHLA AltaMed with parent-reported behavioral concerns whose parents are referred by their pediatricians for participation in the Incredible Years Parenting Program.
- Continuous enrollment in AltaMed Medicaid funded health services during the 24 months prior to participation in IY and 12 months following participation in IY with lapses in coverage of no more than 90 days in length.
- Parents are English or Spanish-speaking or willing to use interpretation if they speak another language.
Who cannot join
- Private (commercial non-Medicaid) insurance coverage for greater than 90 days during the 24 months prior to participation in IY and 12 months following participation in IY.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this study
Official title: The Impact of Evidence-Based Parent Training on Pediatric Health Services Utilization
The purpose of the study is to determine whether parent training with the Incredible Years Parent Program delivered in pediatric primary care decreases usage of healthcare services for the next year when compared to annual healthcare service use during the two years prior to the parents participating in program.
Read the detailed description
Pediatric health services utilization (pHSU) by children with mental health conditions demonstrated dramatic increases between 2006 and 2011. These national trends reflecting large increases in pHSU for mental health conditions were seen across multiple developmental levels. Health services costs for children with mental health conditions are estimated to be twice those for the average child. The Incredible Years® Parent Program (IY) has a strong evidence-base supporting its effectiveness in reducing early onset conduct problems. The overall objective of this stage 3 (T3) translational research proposal is to conduct a pilot study of 45 pediatrician-referred parents who participate in IY and examine the impact of IY on pHSU of their children. Pediatric HSU outcome measures include: all-cause ED visits; in-patient hospitalizations and length of stay; authorizations for specialist referrals; primary and acute care visits; and ED visits for mental health conditions. The investigator's central hypothesis is that children ages 3 to 6 years with behavior concerns whose parents are referred by their pediatricians for participation in IY will have decreased mean annual all-cause pHSU and decreased ED visits for mental health conditions in the 12 months following IY, compared to the 24 months prior to IY participation. This is important to demonstrate because significant financial barriers exist to integrating effective family focused prevention services like IY into pediatric primary care settings. Demonstration of reduced pHSU is one way to address these translational barriers. Results of this pilot study are expected to provide preliminary data on pre- and post-intervention effect sizes; these data will be used to demonstrate the feasibility of collecting data using existing sources of pHSU to design a more fully powered multi-site trial with a robust comparator group.
- Conditions
- Parenting, Child Rearing, Child Behavior Problem
- Being tested
- Video-Based Parent Training Program
- Keywords
- Child Health Services, Pediatric Health Service Utilization, Incredible Years
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Based Parent Training ProgramBehavioural
Also called Incredible Years® Preschool BASIC Parenting Program, Incredible Years® Early Childhood BASIC Parenting Program
An18-20 week evidence-based social cognitive theory-based parenting program where parents see brief video vignettes of effective and less effective parenting and develop concepts to modify their child's behavior.
| Study group | Role | What they receive |
|---|---|---|
| Children of Parents Receiving IY | Children ages 3 to 6 years at start of group with behavior concerns whose parents are referred by their pediatricians for participation in a video-based parent training program from 2014 through 2018. Receives: Behavioral: Video-Based Parent Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Annual Pediatric Health Services Utilization from 24 months prior to IY Parent Group Participation to 12 months following IY Parent Group Participation
(1) all-cause Emergency Department (ED) visits (yes/no) and number; (2) ED visits for mental health conditions (yes/no) and number; (3) in-patient hospitalizations (yes/no) and number, and length of stay in days; (4) authorizations for specialist referrals from AltaMed (yes/no) and number; (5) number of AltaMed primary care visits; (6) AltaMed acute care visits (yes/no) and number; (7) AltaMed mental health visits (yes/no) and number; (8) Children's Hospital Los Angeles (CHLA) specialty mental health visits (yes/no) and number.
Measured: Utilization for 24 months prior to intervention and 12 months following intervention
Secondary outcomes (3)
Eyberg Child Behavior Inventory
Raw and T-scores for Intensity [measures frequency of problem behaviors; range 36 to 252; higher worse] and Problem [measures number of behaviors that are a problem for the parent; range 0 to 36; higher worse] Subscales
Measured: During week before or after starting group; and during week before or after ending group, up to 20 weeks
Youth Outcome Questionnaire (Parent Report)
Total raw score [measures change in frequency of child symptoms and prosocial behaviors; range -16 to 240; higher worse].
Measured: During week before or after starting group; and during week before or after ending group, up to 20 weeks
Pediatric Symptom Checklist
Total raw score [measures frequency of pediatric psychosocial problems; range 0 to 70; higher worse].
Measured: During week before or after starting group; and during week before or after ending group, up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start16 Aug 2018
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
Why it stopped: Current high clinical demands of PI.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- AltaMed Health Services Corporation, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Dean Coffey, Children's Hospital Los Angeles
- Investigators
- DEAN M COFFEY, PsyD, MS, Principal investigator, University of Southern California; Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704974
- Sponsor's protocol ID
- CHLA-17-00001
- Other IDs
- UL1TR001855
- Status last verified
- Nov 2024
- First submitted
- 2 Jul 2018
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan approved by our Institutional Review Board (IRB) for sharing individual participant data.
Publications
General US. Mental health: A report of the surgeon general. Rockville, MD: US Department of Health and Human Services. Substance Abuse and Mental Health Services Administration, Center for Mental Health Services, National Institutes of Health, National Institute of Mental Health. 1999.
US Department of Health and Human Services. The national survey of children's health 2007. US Department of Health and Human Services, Health Resources and Service Administration, Maternal and Child Health Bureau, Rockville, MD. 2009.
Saxena S, Thornicroft G, Knapp M, Whiteford H. Resources for mental health: scarcity, inequity, and inefficiency. Lancet. 2007 Sep 8;370(9590):878-89. doi: 10.1016/S0140-6736(07)61239-2.
PubMed 17804062Perou R, Bitsko RH, Blumberg SJ, Pastor P, Ghandour RM, Gfroerer JC, Hedden SL, Crosby AE, Visser SN, Schieve LA, Parks SE, Hall JE, Brody D, Simile CM, Thompson WW, Baio J, Avenevoli S, Kogan MD, Huang LN; Centers for Disease Control and Prevention (CDC). Mental health surveillance among children--United States, 2005-2011. MMWR Suppl. 2013 May 17;62(2):1-35.
PubMed 23677130Torio CM, Encinosa W, Berdahl T, McCormick MC, Simpson LA. Annual report on health care for children and youth in the United States: national estimates of cost, utilization and expenditures for children with mental health conditions. Acad Pediatr. 2015 Jan-Feb;15(1):19-35. doi: 10.1016/j.acap.2014.07.007. Epub 2014 Nov 13.
PubMed 25444653Fox SE, Levitt P, Nelson CA 3rd. How the timing and quality of early experiences influence the development of brain architecture. Child Dev. 2010 Jan-Feb;81(1):28-40. doi: 10.1111/j.1467-8624.2009.01380.x.
PubMed 20331653Hertzman C, Boyce T. How experience gets under the skin to create gradients in developmental health. Annu Rev Public Health. 2010;31:329-47 3p following 347. doi: 10.1146/annurev.publhealth.012809.103538.
PubMed 20070189Yousafzai AK, Rasheed MA, Rizvi A, Armstrong R, Bhutta ZA. Effect of integrated responsive stimulation and nutrition interventions in the Lady Health Worker programme in Pakistan on child development, growth, and health outcomes: a cluster-randomised factorial effectiveness trial. Lancet. 2014 Oct 4;384(9950):1282-93. doi: 10.1016/S0140-6736(14)60455-4. Epub 2014 Jun 16.
PubMed 24947106Webster-Stratton, C. The Incredible Years®: parents, teachers and children training series. Leader's guide: Preschool version of BASIC. 2008. Seattle, WA
Reid MJ, Webster-Stratton C, Baydar N. Halting the development of conduct problems in head start children: the effects of parent training. J Clin Child Adolesc Psychol. 2004 Jun;33(2):279-91. doi: 10.1207/s15374424jccp3302_10.
PubMed 15136193Reid MJ, Webster-Stratton C, Beauchaine TP. Parent training in head start: a comparison of program response among African American, Asian American, Caucasian, and Hispanic mothers. Prev Sci. 2001 Dec;2(4):209-27. doi: 10.1023/a:1013618309070.
PubMed 11833925Scott S, Briskman J, O'Connor TG. Early prevention of antisocial personality: long-term follow-up of two randomized controlled trials comparing indicated and selective approaches. Am J Psychiatry. 2014 Jun;171(6):649-57. doi: 10.1176/appi.ajp.2014.13050697.
PubMed 24626738Scott S, Spender Q, Doolan M, Jacobs B, Aspland H. Multicentre controlled trial of parenting groups for childhood antisocial behaviour in clinical practice. BMJ. 2001 Jul 28;323(7306):194-8. doi: 10.1136/bmj.323.7306.194.
PubMed 11473908Scott S, Sylva K, Doolan M, Price J, Jacobs B, Crook C, Landau S. Randomised controlled trial of parent groups for child antisocial behaviour targeting multiple risk factors: the SPOKES project. J Child Psychol Psychiatry. 2010 Jan;51(1):48-57. doi: 10.1111/j.1469-7610.2009.02127.x. Epub 2009 Sep 1.
PubMed 19732250Webster-Stratton C. Preventing conduct problems in Head Start children: strengthening parenting competencies. J Consult Clin Psychol. 1998 Oct;66(5):715-30. doi: 10.1037//0022-006x.66.5.715.
PubMed 9803690
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Evidence-Based Parent Training on Pediatric Health Services Utilization
- ClinicalTrials.gov ID
- NCT03704974
- Acronym / sponsor ID
- CHLA-17-00001
- Conditions
- Parenting, Child Rearing, Child Behavior Problem
- Keywords
- Child Health Services, Pediatric Health Service Utilization, Incredible Years
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Current high clinical demands of PI.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- AltaMed Health Services Corporation, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 15 Oct 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 the study is to determine whether parent training with the Incredible Years Parent Program delivered in pediatric primary care decreases usage of healthcare services for the next year when compared to annual healthcare service use during the two years prior to the parents participating in program.
Detailed description
Pediatric health services utilization (pHSU) by children with mental health conditions demonstrated dramatic increases between 2006 and 2011. These national trends reflecting large increases in pHSU for mental health conditions were seen across multiple developmental levels. Health services costs for children with mental health conditions are estimated to be twice those for the average child. The Incredible Years® Parent Program (IY) has a strong evidence-base supporting its effectiveness in reducing early onset conduct problems. The overall objective of this stage 3 (T3) translational research proposal is to conduct a pilot study of 45 pediatrician-referred parents who participate in IY and examine the impact of IY on pHSU of their children. Pediatric HSU outcome measures include: all-cause ED visits; in-patient hospitalizations and length of stay; authorizations for specialist referrals; primary and acute care visits; and ED visits for mental health conditions. The investigator's central hypothesis is that children ages 3 to 6 years with behavior concerns whose parents are referred by their pediatricians for participation in IY will have decreased mean annual all-cause pHSU and decreased ED visits for mental health conditions in the 12 months following IY, compared to the 24 months prior to IY participation. This is important to demonstrate because significant financial barriers exist to integrating effective family focused prevention services like IY into pediatric primary care settings. Demonstration of reduced pHSU is one way to address these translational barriers. Results of this pilot study are expected to provide preliminary data on pre- and post-intervention effect sizes; these data will be used to demonstrate the feasibility of collecting data using existing sources of pHSU to design a more fully powered multi-site trial with a robust comparator group.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children of Parents Receiving IY | – | Behavioral: Video-Based Parent Training ProgramChildren ages 3 to 6 years at start of group with behavior concerns whose parents are referred by their pediatricians for participation in a video-based parent training program from 2014 through 2018. |
Who may qualify
- Ages
- 36 to 83 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children participating in the study will be referred from the AltaMed Federally Qualified Health Center, which manages the primary pediatric care at Children's Hospital Los Angeles for 20,000 children who generate 85,000 outpatient visits per year. The population reflects the diversity of Los Angeles County and is predominantly Latino.
Key inclusion criteria (3 listed)
- Children receiving primary care at CHLA AltaMed with parent-reported behavioral concerns whose parents are referred by their pediatricians for participation in the Incredible Years Parenting Program.
- Continuous enrollment in AltaMed Medicaid funded health services during the 24 months prior to participation in IY and 12 months following participation in IY with lapses in coverage of no more than 90 days in length.
- Parents are English or Spanish-speaking or willing to use interpretation if they speak another language.
Key exclusion criteria (1 listed)
- Private (commercial non-Medicaid) insurance coverage for greater than 90 days during the 24 months prior to participation in IY and 12 months following participation in IY.
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 |
|---|---|---|
| Video-Based Parent Training ProgramAlso: Incredible Years® Preschool BASIC Parenting Program, Incredible Years® Early Childhood BASIC Parenting ProgramAn18-20 week evidence-based social cognitive theory-based parenting program where parents see brief video vignettes of effective and less effective parenting and develop concepts to modify their child's behavior. | Behavioural | Children of Parents Receiving IY |
Primary outcome
Change in Annual Pediatric Health Services Utilization from 24 months prior to IY Parent Group Participation to 12 months following IY Parent Group Participation
Time frame: Utilization for 24 months prior to intervention and 12 months following intervention
(1) all-cause Emergency Department (ED) visits (yes/no) and number; (2) ED visits for mental health conditions (yes/no) and number; (3) in-patient hospitalizations (yes/no) and number, and length of stay in days; (4) authorizations for specialist referrals from AltaMed (yes/no) and number; (5) number of AltaMed primary care visits; (6) AltaMed acute care visits (yes/no) and number; (7) AltaMed mental health visits (yes/no) and number; (8) Children's Hospital Los Angeles (CHLA) specialty mental health visits (yes/no) and number.
3 secondary outcomes
Eyberg Child Behavior Inventory
Time frame: During week before or after starting group; and during week before or after ending group, up to 20 weeks
Youth Outcome Questionnaire (Parent Report)
Time frame: During week before or after starting group; and during week before or after ending group, up to 20 weeks
Pediatric Symptom Checklist
Time frame: During week before or after starting group; and during week before or after ending group, up to 20 weeks
Results and safety
The study was stopped early (reason given: Current high clinical demands of PI.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- BackgroundGeneral US. Mental health: A report of the surgeon general. Rockville, MD: US Department of Health and Human Services. Substance Abuse and Mental Health Services Administration, Center for Mental Health Services, National Institutes of Health, National Institute of Mental Health. 1999.
- BackgroundUS Department of Health and Human Services. The national survey of children's health 2007. US Department of Health and Human Services, Health Resources and Service Administration, Maternal and Child Health Bureau, Rockville, MD. 2009.
- Background: PubMed 17804062Saxena S, Thornicroft G, Knapp M, Whiteford H. Resources for mental health: scarcity, inequity, and inefficiency. Lancet. 2007 Sep 8;370(9590):878-89. doi: 10.1016/S0140-6736(07)61239-2.
- Background: PubMed 23677130Perou R, Bitsko RH, Blumberg SJ, Pastor P, Ghandour RM, Gfroerer JC, Hedden SL, Crosby AE, Visser SN, Schieve LA, Parks SE, Hall JE, Brody D, Simile CM, Thompson WW, Baio J, Avenevoli S, Kogan MD, Huang LN; Centers for Disease Control and Prevention (CDC). Mental health surveillance among children--United States, 2005-2011. MMWR Suppl. 2013 May 17;62(2):1-35.
- Background: PubMed 25444653Torio CM, Encinosa W, Berdahl T, McCormick MC, Simpson LA. Annual report on health care for children and youth in the United States: national estimates of cost, utilization and expenditures for children with mental health conditions. Acad Pediatr. 2015 Jan-Feb;15(1):19-35. doi: 10.1016/j.acap.2014.07.007. Epub 2014 Nov 13.
- Background: PubMed 20331653Fox SE, Levitt P, Nelson CA 3rd. How the timing and quality of early experiences influence the development of brain architecture. Child Dev. 2010 Jan-Feb;81(1):28-40. doi: 10.1111/j.1467-8624.2009.01380.x.
- Background: PubMed 20070189Hertzman C, Boyce T. How experience gets under the skin to create gradients in developmental health. Annu Rev Public Health. 2010;31:329-47 3p following 347. doi: 10.1146/annurev.publhealth.012809.103538.
- Background: PubMed 24947106Yousafzai AK, Rasheed MA, Rizvi A, Armstrong R, Bhutta ZA. Effect of integrated responsive stimulation and nutrition interventions in the Lady Health Worker programme in Pakistan on child development, growth, and health outcomes: a cluster-randomised factorial effectiveness trial. Lancet. 2014 Oct 4;384(9950):1282-93. doi: 10.1016/S0140-6736(14)60455-4. Epub 2014 Jun 16.
- BackgroundWebster-Stratton, C. The Incredible Years®: parents, teachers and children training series. Leader's guide: Preschool version of BASIC. 2008. Seattle, WA
- Background: PubMed 15136193Reid MJ, Webster-Stratton C, Baydar N. Halting the development of conduct problems in head start children: the effects of parent training. J Clin Child Adolesc Psychol. 2004 Jun;33(2):279-91. doi: 10.1207/s15374424jccp3302_10.
- Background: PubMed 11833925Reid MJ, Webster-Stratton C, Beauchaine TP. Parent training in head start: a comparison of program response among African American, Asian American, Caucasian, and Hispanic mothers. Prev Sci. 2001 Dec;2(4):209-27. doi: 10.1023/a:1013618309070.
- Background: PubMed 24626738Scott S, Briskman J, O'Connor TG. Early prevention of antisocial personality: long-term follow-up of two randomized controlled trials comparing indicated and selective approaches. Am J Psychiatry. 2014 Jun;171(6):649-57. doi: 10.1176/appi.ajp.2014.13050697.
- Link to REDCap DatabaseLink provided by the sponsor.
- Individual participant dataSharing planned: No. No current plan approved by our Institutional Review Board (IRB) for sharing individual participant data.
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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.
DEAN M COFFEY, PsyD, MS principal investigator
University of Southern California; Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parenting and Child Rearing, run by Children's Hospital Los Angeles 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 3 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: stopped early, as of the sponsor's last update on 7 Nov 2024. 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 was stopped early (reason given: Current high clinical demands of PI.). Results are not available in the source record.
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 Annual Pediatric Health Services Utilization from 24 months prior to IY Parent Group Participation to 12 months following IY Parent Group Participation (time frame: Utilization for 24 months prior to intervention and 12 months following intervention). 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 NCT03704974, which also lists 33 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 7 Nov 2024.