Internet-based Universal Parent Training as a Booster to PATHS®: Parent Web

Family Relations Clinical Trial

— PW  

Official title:

A Non-randomized Controlled Trial of the Effects of an Internet-delivered Parent Training Intervention (Parent Web) at the Transition to Early Adolescence for Parents of Children That Have Participated in Preschool PATHS®

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05172297
• Other study ID #: FoUI-940010
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: Stockholm University
• Contact: Laura Ferrer-Wreder, PhD.,
• Phone: +4608163898
• Email: laura.ferrer-wreder[@]psychology.su.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To test an online parent training program. Relative to a matched comparison, those in the Parent Web (PW) will show benefits on well-being, parenting, stress, youth mental health. Parents of PATHS children are the immediate intervention group.

Description:

Parent-Web (PW) is internet delivered and rooted in social learning and coercion theory, PW supports parenting practices and parent-child interactions encouraging prosocial behavior and emotion regulation, reduce coercive parenting, improve communication, problem solving, and warmth. PW has a universal and selective edition. Universal PW has 5 basic modules (1 module per week, 6-8 weeks) and bonus modules. Basic modules contain information, exercises, and videos of actors showing parenting practices. A family guide supports PW participants through PW modules. No published outcome evaluations of universal PW currently exist. However, benefits were found for selective PW. This study will test the effects of universal PW as a booster to PATHS (Promoting Alternative Thinking Strategies) a universal school-based intervention designed to enhance child social emotional competence. All PW trial participants are parents to at least one adolescent child (aged 11-13). Immediate PW participants are parents who have a child that participated in PATHS at age 4-5 years old.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 576
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Immediate intervention group are parents of children aged 11-13 who participated in PATHS at age 4-5 years old. Parents in the wait list comparison group have children who are matched to the children of parents in the immediate intervention group. Matching criteria are: Wait-list group parents' child's present-day gender (matching criteria 1) is the same as the matched child who's parents are in the immediate intervention group, wait-list group parents' child's present-day age is similar to the matched child who's parents are in the immediate intervention group, namely child birthdays within 6 months of each other (matching criteria 2), and wait-list group parents' children live in the same postal code as the matched immediate intervention group child (matching criteria 3), and matched children have all lived in Sweden since 2014 (matching criteria 4). If these 4-matching criteria are too restrictive and do not provide enough matches to recruit from, then the matching criteria will be reduced to points 1, 2, and point 3. Children do not participate in the Parent Web intervention trial, but parents of children do participate. Exclusion Criteria: See inclusion criteria

Related Conditions & MeSH terms

• Family Conflict
• Family Dysfunction
• Family Relations

Intervention

Behavioral:
• Parent Web
Parent-Web (PW) is internet delivered and rooted in social learning and coercion theory, PW supports parenting practices and parent-child interactions encouraging prosocial behavior and emotion regulation, reduce coercive parenting, improve communication, problem solving, and warmth. PW has a universal and selective edition. Universal PW has 5 basic modules (1 module per week, 6-8 weeks) and bonus modules. Basic modules contain information, exercises, and videos of actors showing parenting practices. A family guide supports parents through modules.

Locations

Country	Name	City	State
Sweden	Stockholm University	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Stockholm University

Country where clinical trial is conducted

Sweden, 

References & Publications (9)

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Criss MM, Shaw DS. Sibling relationships as contexts for delinquency training in low-income families. J Fam Psychol. 2005 Dec;19(4):592-600. doi: 10.1037/0893-3200.19.4.592. — View Citation

Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x. — View Citation

Hofmann SG, Kashdan TB. The Affective Style Questionnaire: Development and Psychometric Properties. J Psychopathol Behav Assess. 2010 Jun 1;32(2):255-263. doi: 10.1007/s10862-009-9142-4. — View Citation

Malmberg M, Rydell AM, Smedje H. Validity of the Swedish version of the Strengths and Difficulties Questionnaire (SDQ-Swe). Nord J Psychiatry. 2003;57(5):357-63. doi: 10.1080/08039480310002697. — View Citation

Pelham WE Jr, Gnagy EM, Greenslade KE, Milich R. Teacher ratings of DSM-III-R symptoms for the disruptive behavior disorders. J Am Acad Child Adolesc Psychiatry. 1992 Mar;31(2):210-8. doi: 10.1097/00004583-199203000-00006. Erratum In: J Am Acad Child Adolesc Psychiatry 1992 Nov;31(6):1177. — View Citation

Ringle JL, Mason WA, Oats RG, Cogua J. Parenting Children and Adolescents (PARCA) scale English to Spanish translation: An investigation of measurement invariance. J Fam Psychol. 2019 Dec;33(8):938-944. doi: 10.1037/fam0000559. Epub 2019 Jul 18. — View Citation

Wetterborg D, Enebrink P, Lonn Rhodin K, Forster M, Risto E, Dahlstrom J, Forsberg K, Ghaderi A. A pilot randomized controlled trial of Internet-delivered parent training for parents of teenagers. J Fam Psychol. 2019 Oct;33(7):764-774. doi: 10.1037/fam0000541. Epub 2019 Jun 17. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in parent rating of child's emotional problems, conduct problems, hyperactivity, peer problems and prosocial behavior	Change from baseline up to 10 months later (immediate intervention group, two time points) and up to 20 months later (wait-list comparison group, three time points) in parent rating of their child's emotional problems, conduct problems, hyperactivity, peer problems and prosocial behavior as indexed by the Strengths and Difficulties Questionnaire (SDQ). The SDQ consists of 25 items rated on a 3-point Likert scale with response options that range from 0 = not true, 1 = somewhat true, 2 = certainly true. Higher scores indicate a worse outcome on the emotional problems, conduct problems, hyperactivity, peer problems scale scores. Higher scores on the prosocial behavior scale indicate a better outcome.	Immediate PW group pretest in Fall 2022. Post test up to 10 months after pretest. Wait-list group pretest in Fall 2022. Post test 1 up to 10 months after pretest. Post test 2 for wait-list up to 10 months after post test 1
Primary	Change from baseline in parent rated view of their child's behavioral problems/defiant behavior	Change from baseline up to 10 months later (immediate intervention group, two time points) and up to 20 months later (wait-list comparison group, three time points) in parent view of their child's behavioral problems/defiant behavior as measured by the Oppositional Defiant Scale of the Disruptive Disorder Rating Scale (DBD) which consists of 7 items rated on a 4-point scale ranging from 1 (not at all) to 4 (very much). Higher scores indicate a worse outcome.	Immediate PW group pretest in Fall 2022. Post test up to 10 months after pretest. Wait-list group pretest in Fall 2022. Post test 1 up to 10 months after pretest. Post test 2 for wait-list up to 10 months after post test 1
Primary	Change from baseline in parent rated family warmth and conflict	Change from baseline up to 10 months later (immediate intervention group, two time points) and up to 20 months later (wait-list comparison group, three time points) in parent rated warmth and conflict. Warmth and conflict are indexed by eight items rated on a five-point scale from 1 (never) to 5 (more than 7 times). Five items measure parent-child warmth and three items measure parent-child conflicts. Higher scores on parental warmth scale indicate a better outcome. Higher scores on the parent-child conflicts scale score indicate a worse outcome.	Immediate PW group pretest in Fall 2022. Post test up to 10 months after pretest. Wait-list group pretest in Fall 2022. Post test 1 up to 10 months after pretest. Post test 2 for wait-list up to 10 months after post test 1
Secondary	Change from baseline in parent rated encouragement of positive behaviors, setting limits, and proactive parenting behaviors	Change from baseline up to 10 months later (immediate intervention group, two time points) and up to 20 months later (wait-list comparison group, three time points) in parent rated encouragement of positive behaviors, setting limits, and proactive parenting behaviors as indexed by the Parenting Children and Adolescents Scale (PARCA). The PARCA has 19 items rated on a five-point scale 1 = never to 5 = Very Often. The scale has three subscales on encouragement of positive behaviors, setting limits, and proactive parenting behaviors. Higher scores indicate a better outcome.	Immediate PW group pretest in Fall 2022. Post test up to 10 months after pretest. Wait-list group pretest in Fall 2022. Post test 1 up to 10 months after pretest. Post test 2 for wait-list up to 10 months after post test 1
Secondary	Change from baseline in parent rated stress	Change from baseline up to 10 months later (immediate intervention group, two time points) and up to 20 months later (wait-list comparison group, three time points) in parent rated stress as measured by the Perceived Stress Scale (PSS). PSS consists of 10 questions about perceived stress during the last month rated on a 5-point Likert scale (0 = Never to 4 = Very Often). The scale measures the extent to which situations in one's life are assessed and perceived as stressful and current stress levels. Higher scores indicate a worse outcome.	Immediate PW group pretest in Fall 2022. Post test up to 10 months after pretest. Wait-list group pretest in Fall 2022. Post test 1 up to 10 months after pretest. Post test 2 for wait-list up to 10 months after post test 1
Secondary	Change from baseline in parent rated health	Change from baseline up to 10 months later (immediate intervention group, two time points) and up to 20 months later (wait-list comparison group, three time points) in parent rated health as measured by the Hospital Anxiety and Depression Scale (HAD). HAD consists of two scales (a total of 14 items), one for anxiety and one for depression with seven questions each. Items are rated on a 4-point Likert scale. Higher scores indicate a worse outcome.	Immediate PW group pretest in Fall 2022. Post test up to 10 months after pretest. Wait-list group pretest in Fall 2022. Post test 1 up to 10 months after pretest. Post test 2 for wait-list up to 10 months after post test 1
Secondary	Change from baseline in parent rated parents validation of their child's emotions when expressed	Change from baseline up to 10 months later (immediate intervention group, two time points) and up to 20 months later (wait-list comparison group, three time points) in parent rated affective style as measured by the tolerating subscale of the Affective Style Questionnaire (ASQ). The ASQ consists of five items (rated on a 3 point Likert scale, 1 = Completely Agree to 3 = Completely Disagree) that examine how parents view their own validation of their child's emotions when expressed. Higher scores indicate a worse outcome.	Immediate PW group pretest in Fall 2022. Post test up to 10 months after pretest. Wait-list group pretest in Fall 2022. Post test 1 up to 10 months after pretest. Post test 2 for wait-list up to 10 months after post test 1