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AutismNCT02236650

Primary Care Stepping Stones Triple P for Children With Autism

A study testing Primary Care Stepping Stones Triple P (PC-SS Triple P) and Treatment as Usual in people with Autism, run by St. Louis University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the effectiveness of Primary Care Stepping Stones Triple P (PC-SS Triple P), an empirically supported parent mediated intervention, to improve the behavioral functioning of children newly diagnosed with Autism (aged 2-12 years), increase parental resilience and decrease… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Autism
What is being tested?
Primary Care Stepping Stones Triple P (PC-SS Triple P) and Treatment as Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
Jul 2014to Dec 2015
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Parent inclusion criteria:
  • being at least 18 years of age
  • Index child inclusion criteria:
  • receives a Diagnostic and Statistical Manual V (DSM-V) diagnosis of Autism with mild or moderate severity within 12 months of study onset.
  • age is > or equal to 24 months (2 years, 0 months) and < or equal to 155 months old (12 years, 11 months).

Who cannot join

  • Parent exclusion criteria:
  • inability to provide informed consent.
  • being non-English speaking.
  • Index child exclusion criteria:
  • being a ward of the State of Missouri.
  • being a sibling of another study participant.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Saint Louis University, Knights of Columbus Developmental Center

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Pilot Study of Primary Care Stepping Stones Triple P for Children With Autism

The purpose of this study is to determine the effectiveness of Primary Care Stepping Stones Triple P (PC-SS Triple P), an empirically supported parent mediated intervention, to improve the behavioral functioning of children newly diagnosed with Autism (aged 2-12 years), increase parental resilience and decrease parental stress.

Read the detailed description

Research literature exists on best practices for screening and diagnosing children with Autism. However, less is known about how to intervene with the child's parent. Across studies, relative to parents of children without disabilities, parents of children with Autism have reported higher levels of stress and lower levels of parenting competence. Such stress places children at risk for adverse developmental outcomes

The proposed study aims to determine the effectiveness of Primary Care Stepping Stones Triple P (PC-SS Triple P), an empirically supported parent mediated intervention, to improve the behavioral functioning of children newly diagnosed with Autism (aged 2-12 years), increase parental resilience and decrease parental stress.

The specific hypotheses include:

  1. Children whose parents receive PC-SS Triple P will demonstrate significantly greater improvements in their behavioral functioning than children of parents receiving Wait-list Control (WLC) at service closure.
  2. At service closure, parents receiving the PC-SS Triple P intervention will be more resilient and demonstrate lower levels of stress than parents in the Wait-List Control (WLC) condition.
  3. Parenting resilience and levels of parental stress will be positively associated with improvements in child behavior.

Seventy-six parents of children newly diagnosed with Autism will be randomized into one of two conditions: a) PC-SS Triple P (N=38) or b) Wait List Control (WLC; N=38). Study data will be collected with the assistance of a data collector appropriately trained in human subject rights protections.

It is anticipated that the present project will assist in the development and use of evidence-based practices for working with parents of children newly diagnosed with Autism within pediatric settings.

Conditions
Autism
Being tested
Primary Care Stepping Stones Triple P (PC-SS Triple P), Treatment as Usual
Keywords
Parental Resilience, Parental Stress, Family Adaptation, Autistic Disorder, Behavior, Child Behavior, Child Development Disorders, Pervasive Developmental Disabilities, Caregivers, Parents, Parenting, Primary Health Care
Medical subject headings
Autistic Disorder, Behavior, Child Behavior, Developmental Disabilities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Primary Care Stepping Stones Triple P (PC-SS Triple P)Behavioural

    Also called Postive Parenting Program, Triple P, Stepping Stones Triple P, Stepping Stones Positive Parenting Program

    PC-SS Triple P is a parenting and family support strategy that aims to prevent and treat behavioral problems in children by enhancing parental resilience.

  • Treatment as UsualOther

    Also called Service as Usual

    Treatment as Usual for 4 weeks

Study groups in NCT02236650
Study groupRoleWhat they receive
Primary Care Stepping Stones Triple PExperimentalPrimary Care Stepping Stones Triple P program (PC-SS Triple P) - a parenting and family support strategy that aims to prevent and treat behavioral problems in children by enhancing parental resilience.
Receives: Behavioral: Primary Care Stepping Stones Triple P (PC-SS Triple P)
Wait List Control (WLC)Active comparatorWait List Control - Participants who will have access to treatment as usual services during the 4 weeks between baseline and 4 week assessment time points and then will have the opportunity to receive PC-SS Triple P.
Receives: Other: Treatment as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Eyberg Child Behavior Inventory Score at 4 weeks

    Measure conduct problem behavior in children between the ages of 2 and 16 years.

    Measured: Baseline and 4 weeks

  2. Change from Baseline in Connor-Davidson Resilience Scale Score at 4 weeks

    General scale of resilience in adult populations with a bias towards coping with stress and adversity.

    Measured: Baseline and 4 weeks

  3. Change from Baseline in Parent Stress Index - Short Form Score at 4 weeks

    Sources and different types of stress that every parent can experience. Provides information in 4 specific domains of parenting stress:

    1. Parental Distress,
    2. Parent-Child Dysfunctional Interaction,
    3. Difficult Child, and
    4. Total Stress.

    Measured: Baseline and 4 weeks

  4. Change from Baseline in Family Assessment Device score at 4 weeks

    Assesses family functioning on six different dimensions:

    1. Problem Solving (ability to resolve problems),
    2. Communication (exchange of clear and direct verbal information),
    3. Roles (division of responsibility for completing family tasks),
    4. Affective Responsiveness (ability to respond with appropriate emotion),
    5. Affective Involvement (degree to which family members are involved and interested in one another), and
    6. Behavior Control (manner used to express and maintain standards of behavior).

    Measured: Baseline and 4 weeks

Secondary outcomes (3)

  1. Change from Baseline in Aberrant Behavior Checklist Score at 4 weeks

    Assesses behavior problems in individuals with developmental disabilities across 5 domains:

    1. Irritability and Agitation (15 items)
    2. Lethargy and Social Withdrawal (16 items)
    3. Stereotypic Behavior (7 items)
    4. Hyperactivity and Noncompliance (16 items) and
    5. Inappropriate Speech (4 items).

    Measured: Baseline and 4 weeks

  2. Change from Baseline in The Parenting Scale Score at 4 weeks

    Measures dysfunctional discipline styles in parents by asking about the probability with which the parent uses particular discipline strategies. It yields four scores:

    1. Total score,
    2. Laxness (permissive, inconsistent discipline);
    3. Over-reactivity (harsh, emotional, authoritarian discipline and irritability); and
    4. Verbosity/Hostility (use of verbal or physical force).

    Measured: Baseline and 4 weeks

  3. Change from Baseline in the Parenting Sense of Competence Scale Score at 4 weeks

    Measures parents' sense of confidence and satisfaction with their parenting and their self-efficacy in the parenting role.

    Measured: Baseline and 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

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
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02236650
Sponsor's protocol ID
SLUBM_24272
Status last verified
Dec 2015
First submitted
8 Sep 2014
Last updated
17 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • Turner K, Markie-Dadds C, Sanders M. Practitioner's manual for primary care tripleP. Brisbane, QLD, Australia: Triple P International Pty. Ltd.; 2010.

  • Mazzucchelli T, Sanders M. Stepping Stones Triple P: A Population Approach to the Promotion of Competent Parenting of Children with Disability. Brisbane, Queensland, Australia,: The University of Queensland;2012.

  • Prinz RJ, Sanders MR, Shapiro CJ, Whitaker DJ, Lutzker JR. Population-based prevention of child maltreatment: the U.S. Triple p system population trial. Prev Sci. 2009 Mar;10(1):1-12. doi: 10.1007/s11121-009-0123-3.

    PubMed 19160053

  • Sanders M, Morawska A. Can changing parental knowledge, dysfunctional expectations and attributions, and emotion regulation improve outcomes for children? In: Tremblay R, Boivin M, Peters R, eds. Encyclopedia on Early Childhood Development [online]. 2nd ed. Montreal, Quebec: Centre of Excellence for Early Childhood Development 2008:1-12.

  • Sanders MR, Markie-Dadds C, Tully LA, Bor W. The triple P-positive parenting program: a comparison of enhanced, standard, and self-directed behavioral family intervention for parents of children with early onset conduct problems. J Consult Clin Psychol. 2000 Aug;68(4):624-40.

    PubMed 10965638

  • Sanders, Mazzucchelli T, Studman L. Stepping Stones Triple P: The theoretical basis and development of an evidence-based positive parenting program for families with a child who has a disability. Journal of Intellectual & Developmental Disability. 2004 2004;29(3):265-283.

  • Tellegen CL, Sanders MR. Stepping Stones Triple P-Positive Parenting Program for children with disability: a systematic review and meta-analysis. Res Dev Disabil. 2013 May;34(5):1556-71. doi: 10.1016/j.ridd.2013.01.022. Epub 2013 Mar 6.

    PubMed 23475006

  • Whittingham K, Sofronoff K, Sheffield J, Sanders MR. Stepping Stones Triple P: an RCT of a parenting program with parents of a child diagnosed with an autism spectrum disorder. J Abnorm Child Psychol. 2009 May;37(4):469-80. doi: 10.1007/s10802-008-9285-x.

    PubMed 19023654

  • Becvar D. Handbook of family resilience. New York, NY: Springer; 2012.

  • Roberts C, Mazzucchelli T, Studman L, Sanders MR. Behavioral family intervention for children with developmental disabilities and behavioral problems. J Clin Child Adolesc Psychol. 2006 Jun;35(2):180-93. doi: 10.1207/s15374424jccp3502_2.

    PubMed 16597214

  • Eyberg S, Pincus D. Eyberg Child Behavior Inventory and Sutter-Eyberg Student Behaviour Inventory- Revised: Professional manual. Odessa, FL: Psychological Assessment Resources; 1999.

  • Aman MG, Singh NN, Stewart AW, Field CJ. The aberrant behavior checklist: a behavior rating scale for the assessment of treatment effects. Am J Ment Defic. 1985 Mar;89(5):485-91.

    PubMed 3993694

  • Karabekiroglu K, Aman MG. Validity of the aberrant behavior checklist in a clinical sample of toddlers. Child Psychiatry Hum Dev. 2009 Mar;40(1):99-110. doi: 10.1007/s10578-008-0108-7. Epub 2008 Jul 4.

    PubMed 18600444

  • Guy WR, 1976. M. ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: US Department of Heath, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration; 1976.

  • Arnold D, O'Leary S, Wolff S, Acher M. The Parenting Scale: A measure of dysfunctional parenting in discipline situations. Psychological Assessment. 1993 1993;5:137-144.

Questions about this trial

What is this clinical trial studying?

A study testing Primary Care Stepping Stones Triple P (PC-SS Triple P) and Treatment as Usual in people with Autism, run by St. Louis 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 5 inclusion and 6 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 17 Dec 2015. 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 from Baseline in Eyberg Child Behavior Inventory Score at 4 weeks (time frame: Baseline and 4 weeks). The study lists 4 primary outcomes in all. 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 NCT02236650, which also lists 40 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 17 Dec 2015.

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