A Trial of "Coping Coach," a Web-based Preventive Intervention for Children

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ClinicalTrials.gov Identifier: NCT01653288

Recruitment Status : Completed

First Posted : July 31, 2012

Results First Posted : February 26, 2019

Last Update Posted : February 26, 2019

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

The University of Queensland

Information provided by (Responsible Party):

Children's Hospital of Philadelphia

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention
Condition	Stress Disorders, Post Traumatic
Intervention	Behavioral: Coping Coach
Enrollment	72

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Coping Coach	Coping Coach Waitlist Control
Arm/Group Description	Receive access to Coping Coach onli...	Treatment as usual till 12 wk asses...
Arm/Group Description	Receive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks. Coping Coach: Coping Coach is a self-guided web-based intervention that utilizes an interactive, developmentally appropriate, game-like format, to provide practical information and teach children adaptive coping strategies. Children are primary users of the intervention, with parent supervision. Modules (20-30 minutes each) can be repeated to solidify skills / learning. The feelings module targets recognition of emotions after potentially traumatic experiences. The appraisals module targets the connection of helpful or unhelpful thoughts to feelings and behavior. The avoidance module targets reducing reliance on avoidance as a (maladaptive) coping response. Promoting social support is folded throughout the intervention. Information will be provided to parents about how to access additional resources and when to get additional professional help.	Treatment as usual till 12 wk assessment, then access to Coping Coach intervention for use (self-guided, email reminders) over next 6 wks. Coping Coach: Coping Coach is a self-guided web-based intervention that utilizes an interactive, developmentally appropriate, game-like format, to provide practical information and teach children adaptive coping strategies. Children are primary users of the intervention, with parent supervision. Modules (20-30 minutes each) can be repeated to solidify skills / learning. The feelings module targets recognition of emotions after potentially traumatic experiences. The appraisals module targets the connection of helpful or unhelpful thoughts to feelings and behavior. The avoidance module targets reducing reliance on avoidance as a (maladaptive) coping response. Promoting social support is folded throughout the intervention. Information will be provided to parents about how to access additional resources and when to get additional professional help.
Period Title: Overall Study
Started	36	36
Completed	26	35
Not Completed	10	1

Baseline Characteristics

Arm/Group Title		Coping Coach	Coping Coach Waitlist Control	Total
Arm/Group Description		Receive access to Coping Coach onli...	Treatment as usual till 12 wk asses...	Total of all reporting groups
Arm/Group Description		Receive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks. Coping Coach: Coping Coach is a self-guided web-based intervention that utilizes an interactive, developmentally appropriate, game-like format, to provide practical information and teach children adaptive coping strategies. Children are primary users of the intervention, with parent supervision. Modules (20-30 minutes each) can be repeated to solidify skills / learning. The feelings module targets recognition of emotions after potentially traumatic experiences. The appraisals module targets the connection of helpful or unhelpful thoughts to feelings and behavior. The avoidance module targets reducing reliance on avoidance as a (maladaptive) coping response. Promoting social support is folded throughout the intervention. Information will be provided to parents about how to access additional resources and when to get additional professional help.	Treatment as usual till 12 wk assessment, then access to Coping Coach intervention for use (self-guided, email reminders) over next 6 wks. Coping Coach: Coping Coach is a self-guided web-based intervention that utilizes an interactive, developmentally appropriate, game-like format, to provide practical information and teach children adaptive coping strategies. Children are primary users of the intervention, with parent supervision. Modules (20-30 minutes each) can be repeated to solidify skills / learning. The feelings module targets recognition of emotions after potentially traumatic experiences. The appraisals module targets the connection of helpful or unhelpful thoughts to feelings and behavior. The avoidance module targets reducing reliance on avoidance as a (maladaptive) coping response. Promoting social support is folded throughout the intervention. Information will be provided to parents about how to access additional resources and when to get additional professional help.	Total of all reporting groups
Overall Number of Baseline Participants		36	36	72
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	36 participants	36 participants	72 participants
	<=18 years	36 100.0%	36 100.0%	72 100.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	36 participants	36 participants	72 participants
		9.8 (1.5)	9.8 (1.3)	9.8 (1.4)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	36 participants	36 participants	72 participants
	Female	15 41.7%	18 50.0%	33 45.8%
	Male	21 58.3%	18 50.0%	39 54.2%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
Child race / ethnicity	Number Analyzed	36 participants	36 participants	72 participants
	Black	12 33.3%	12 33.3%	24 33.3%
	White	21 58.3%	24 66.7%	45 62.5%
	Other race / ethnicity	3 8.3%	0 0.0%	3 4.2%
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants
United States	Number Analyzed	36 participants	36 participants	72 participants
United States		36 100.0%	36 100.0%	72 100.0%
Parent education Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	36 participants	36 participants	72 participants
	Attended or completed high school	7 19.4%	7 19.4%	14 19.4%
	Attended college	20 55.6%	8 22.2%	28 38.9%
	Completed college or graduate degree	9 25.0%	21 58.3%	30 41.7%
Annual household income Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	36 participants	36 participants	72 participants
	less than $30K	10 27.8%	6 16.7%	16 22.2%
	$30K to less than $50K	8 22.2%	7 19.4%	15 20.8%
	$50K to less than $75K	4 11.1%	4 11.1%	8 11.1%
	$75K to less than $100K	5 13.9%	4 11.1%	9 12.5%
	$100K or more	8 22.2%	15 41.7%	23 31.9%
	Not reported	1 2.8%	0 0.0%	1 1.4%
Type of acute medical event experienced by child Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	36 participants	36 participants	72 participants
	Appendicitis	13 36.1%	18 50.0%	31 43.1%
	Asthma-related	4 11.1%	2 5.6%	6 8.3%
	Abdominal pain	3 8.3%	3 8.3%	6 8.3%
	Acute joint pain or arthritis	1 2.8%	3 8.3%	4 5.6%
	Other acute medical illness	9 25.0%	6 16.7%	15 20.8%
	Injury	6 16.7%	4 11.1%	10 13.9%
Child's prior trauma exposure Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	36 participants	36 participants	72 participants
Any prior trauma	yes	27 75.0%	25 69.4%	52 72.2%
Any prior trauma	no	9 25.0%	11 30.6%	20 27.8%
Prior interpersonal trauma	yes	7 19.4%	3 8.3%	10 13.9%
Prior interpersonal trauma	no	29 80.6%	33 91.7%	62 86.1%
Prior non-interpersonal trauma	yes	27 75.0%	24 66.7%	51 70.8%
Prior non-interpersonal trauma	no	9 25.0%	12 33.3%	21 29.2%
Baseline stats for outcome measures ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale	Number Analyzed	36 participants	36 participants	72 participants
mean (SD) CPTCI score - maladaptive appraisals		45.4 (12.1)	40.5 (11.6)	43.0 (12.0)
mean (SD) HICUPS score - avoidance coping)		32.4 (7.3)	29.3 (7.4)	30.9 (7.5)
mean (SD) CPSS score - traumatic stress severity		18.4 (11.8)	13.3 (7.3)	15.6 (10.1)
mean (SD) PedsQL score - health quality of life		78.0 (17.3)	82.1 (15.8)	79.9 (16.6)
		[1] Measure Description: Child PTSD Symptom Scale (CPSS) measures child posttraumatic stress symptoms, possible range 0-51, high scores = more severe. Pediatric Quality of Life Inventory (PedsQL) measures child health-related quality of life, possible range 0-100, high scores = better quality of life. How I Coped Under Pressure Scale (HICUPS) measures child avoidance coping strategies, possible range 12-48, high scores = more use of avoidance coping. Child Posttraumatic Cognitions Inventory (CPTCI) measures child post trauma cognitive appraisals, possible range 25-100, high scores = more maladaptive appraisals.

Outcome Measures

1.Primary Outcome


Title	Feasibility of the Coping Coach Online Intervention
Description	Feasibility was measured using automated monitoring data, the number o...
Description	Feasibility was measured using automated monitoring data, the number of participants who logged in at least once and the number of participants who completed the entire online intervention are presented here.
Time Frame	6 weeks

Outcome Measure Data